Tuesday, July 31, 2012

What Causes White Spots To Appear on a Person's Skin, And Can One Get Rid Of Them?

If you have suddenly begun seeing white spots appearing on your skin, you will no doubt be concerned that you may have picked up an infection of some kind, or maybe you are worried you have some serious illness. The good news is, spots are rarely connected to anything serious. Read more

Safra anuncia oferta para comprar ações de classe B registradas e publicamente negociadas do Sarasin

Safra anuncia oferta para comprar ações de classe B registradas e publicamente negociadas do Sarasin

LUXEMBURGO, 31 de julho de 2012 /PRNewswire/ -- O Safra anunciou hoje sua intenção de fazer uma oferta de compra de ações de classe "B" registradas e publicamente negociadas do Bank Sarasin & Co. Ltd, de Basiléia, Suiça (Sarasin), a CHF 27,00 por ação. A oferta deverá ser feita em 20 de agosto de 2012 pela JSH S.A. Luxembourg, uma entidade do Safra. Sujeita a potenciais adiamentos ou prorrogações, a oferta deverá ser aberta para aceitações de 4 de setembro de 2012 a 17 de setembro de 2012.

A oferta segue o fechamento em 31 de julho de 2012 da aquisição previamente anunciada de participação do Rabobank no Sarasin pelo Safra. Em decorrência do fechamento, o Safra detém agora 50,15% do capital social e 71,01% dos direitos de voto do Bank Sarasin.

Considerando a tendência geral com relação às exigências de maior capital para bancos e outras instituições financeiras, o Safra espera que o Bank Sarasin irá, no futuro, fortalecer sua base de participação acionária, aumentando seu capital social em um valor de aproximadamente CHF 250 milhões. Além disso, a política de dividendos do Bank Sarasin será ajustada para refletir a política aplicada às empresas dentro do Grupo Europeu (European Group) do Safra, que, no momento, se foca no reinvestimento total das receitas no desenvolvimento e fortalecimento de seus negócios e irá, por consequência, envolver distribuições eliminadoras aos acionistas, incluindo em 2012.

O Credit Suisse está atuando como consultor financeiro do Safra e coordenador da transação, em conexão com a oferta.

Para mais informações:
Kekst and Company
Robert Siegfried, (+1) 212-521-4832 / (+1) 917-842-1126 | e-mail:
robert-siegfried@kekst.com
Jeremy Fielding, (+1) 212-521-4858 / (+1) 646-644-4825 | e-mail: jeremy-fielding@kekst.com
Mark Semer, (+1) 212-521-4802 / (+1) 917-439-3507 | e-mail: mark-semer@kekst.com

Safra Group

O Safra Group é um nome altamente conceituado no mundo em atividades bancárias, com uma história duradoura de sucesso. Os bancos do grupo Safra incluem o Banco Safra, Banque J. Safra (Suíça), Banque J. Safra (Mônaco), Banque Safra Luxembourg, Bank J. Safra (Gibraltar), Safra National Bank of New York e o Safra International Bank and Trust, todos desenvolvidos em fortes fundações financeiras. Em dezembro de 2011, o Safra Group agregou participação de acionistas no valor de aproximadamente US$ 12 bilhões e ativos totais sob sua administração no valor de US$ 101 bilhões. Os bancos do grupo Safra estão presentes em 125 localidades no mundo e têm mais de 6.300 funcionários.

DISTRIBUIÇÃO NÃO AUTORIZADA PARA OS ESTADOS UNIDOS DA AMÉRICA

FONTE Safra Group

SOURCE Safra Group

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Source: www.prnewswire.com

Emergency Medicine Organizations Herald New Office of Emergency Care Research at NIH as An Investment in the Future

Emergency Medicine Organizations Herald New Office of Emergency Care Research at NIH as An Investment in the Future

WASHINGTON, July 31, 2012 /PRNewswire-USNewswire/ -- The American College of Emergency Physicians (ACEP) and the Society for Academic Emergency Medicine (SAEM) today lauded the announcement by the National Institutes of Health (NIH) about the creation of a new Office of Emergency Care Research (OECR) as a gift to emergency patients everywhere.  The NIH is the largest federal agency dedicated to medical research.  The formation of the OECR has been heralded as a significant advance for emergency medicine investigators and emergency patients.

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"This is a landmark event for emergency care research," said David Seaberg, MD, FACEP, president of the American College of Emergency Physicians.  "It would not have been possible without longstanding leadership by and collaboration among ACEP, SAEM and many individual emergency physicians dedicated to advancing emergency care through research."

"The creation of the OECR is a major step forward for emergency patients whose illnesses and injuries cross the whole spectrum of medicine, from neurology to trauma to pediatrics," said Debra Houry, MD, MPH, past president of SAEM.  "The unique challenges of emergency medicine finally have one home at the national level committed to studying key issues affecting the 136 million patients who visit emergency departments every year."

A dedicated centralized office for emergency care research was called for in previous research reports issued by ACEP and SAEM and was a key recommendation of the IOM Report on Emergency Care issued in 2006.  In addition, the immediate past president of SAEM, Jill Baren, MD, MBE, FACEP, FAAP, professor and chair of the Department of Emergency Medicine at the University of Pennsylvania in Philadelphia, Pa. hailed the announcement as a great step forward for the emergency medical research community, and by extension, the patients who benefit from that research.

Since the release of the IOM Report in 2006, members of an ACEP/SAEM Task Force have been collaborating with the NIH to advance emergency care research.  This collaboration has resulted in a number of recent developments, including: the NIH Emergency Medicine Research Roundtable reports released in 2010; the awarding of the first national K12 grant program by the National Heart, Lung and Blood Institute specifically for the career development of emergency medicine researchers in 2011; and the newly established OECR.

"Emergency medicine has been shown to directly affect the quality and duration of patients' lives and this investment by the NIH in emergency care research provides a formal structure to advance the field," said Charles B. Cairns, MD, FACEP, professor and chair at the University of North Carolina School of Medicine in Chapel Hill, N.C. and co-chair of the ACEP/SAEM joint task force.

"The establishment of a dedicated NIH office reflects the sincerity of the NIH's commitment to support emergency care research," said Roger J. Lewis, MD, Ph.D., FACEP, professor of medicine at Harbor-UCLA Medical Center in Los Angeles, Calif. and ACEP/SAEM Task Force co-chair.

Robert W. Neumar, MD, Ph.D., FACEP, associate professor of emergency medicine at the University of Pennsylvania in Philadelphia, Pa. and ACEP/SAEM Task Force member, agreed: "The creation of the OECR offers lasting evidence that the efforts that we've engaged in over the past six years are paying off."

ACEP/SAEM Task Force members have met with the NIH Director Dr. Francis S. Collins to address concerns raised in the NIH Emergency Research Roundtable Reports. The development of the OECR is a direct result of these discussions. 

Dr. Walter Koroshetz, the Deputy Director of the National Institute of Neurological and Stroke Disorders, has been named the Acting Director of OECR.  Dr. Koroshetz has been actively engaged in the Roundtable reports and in discussions with Director Collins regarding emergency care research.   The Acting Deputy Director will be Alice M. Mascette, MD, senior clinical science advisor in the Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute.  The establishment of the OECR is groundbreaking precisely because until now there has been disagreement about which institute or center emergency care research falls under at the NIH.  The NIH's structure hasn't enabled research into the evaluation and treatment of emergency patients because it doesn't naturally fall into any specific institute or center within the NIH.

"This announcement is a boon to emergency care researchers in academia across the country," said Craig Newgard, MD, FACEP, Ph.D., associate professor of emergency medicine at Oregon Health & Science University in Portland Ore. and an ACEP/SAEM Task Force member. "The leaders of residency programs and academic departments of emergency medicine will need to identify potential researchers and intensify research efforts."

"The NIH investment in emergency care research will require that emergency physicians identify key research areas, including those that aim at improving efficiency and resource utilization in our increasingly overburdened emergency care system," said David Sklar, MD, FACEP, professor of emergency medicine at the University of New Mexico in Albuquerque, N.M., and a past member of the ACEP/SAEM Task Force.

The immediate past president of ACEP, Sandra Schneider, MD, FACEP, saluted the announcement as the fulfillment of longstanding goal of ACEP.  

"Although the number of institutes has been frozen, preventing emergency medicine from having its own institute, the OECR will be the dedicated advocate for funding within NIH," said ACEP's immediate past president and a past president of SAEM, Sandra Schneider, MD, FACEP, of the Department of Emergency Medicine at the University of Rochester in Rochester, N.Y.  "The establishment of the OECR at NIH required input from many outside groups but also internal support from NIH staff. This would not have happened without those scientists who were willing to champion the effort. The NIH is one of the world's largest research organizations with over $30 billion a year in annual funding, so for emergency medicine to have a dedicated office within the NIH is a remarkable accomplishment for our field."

Drs. Seaberg and Schneider further commended the work of other ACEP/SAEM Task Force members in supporting the creation of the OECR, specifically Drs. James Hoekstra, Judd Hollander, Arthur Kellermann, Edward Sloan and John Younger. Drs. Seaberg and Schneider further acknowledge financial contributions by emergency physicians to the Emergency Medicine Fund and the SAEM Fund as instrumental in the successful effort to create the OECR. 

ACEP is a national medical specialty society representing emergency medicine. ACEP is committed to advancing emergency care through continuing education, research and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies. 

SAEM leads the advancement of emergency care through education and research, advocacy, and professional development in academic emergency medicine. Headquartered in Chicago, IL, SAEM is the academic voice of emergency medicine and has nearly 6,000 members from medical schools and teaching institutions in the United States and throughout the world. The Society brings together diverse individuals who are interested in the pursuit of knowledge and the promotion of academic emergency medicine and research in this field.

SOURCE American College of Emergency Physicians (ACEP)

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Source: www.prnewswire.com

Cell Therapeutics, Inc. (CTI) to Report Second Quarter Financial Results on August 1

Cell Therapeutics, Inc. (CTI) to Report Second Quarter Financial Results on August 1

SEATTLE, July 31, 2012 /PRNewswire/ -- On Wednesday, August 1, 2012, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of Cell Therapeutics, Inc.'s (CTI) (NASDAQ and MTA: CTIC) management team will host a conference call to discuss the Company's 2012 second quarter achievements and financial results.

Conference Call Numbers
Wednesday, August 1
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-6010 (US Participants)
1-480-629-9644 (International)
Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1- 800-406-7325 (US Participants)
1- 303-590-3030 (International)
Passcode: 4552195 #
Live audio webcast at
www.celltherapeutics.com will be archived for post listening approximately two hours after call ends.

SOURCE Cell Therapeutics, Inc.

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Source: www.prnewswire.com

Monday, July 30, 2012

New Center at Abt Associates to Focus on Risk and Resilience

New Center at Abt Associates to Focus on Risk and Resilience

BETHESDA, Md., July 30, 2012 /PRNewswire/ -- How can vulnerable populations protect themselves against risk and mitigate the effects of financial, environmental or health-related events that could negatively affect them? That question is at the heart of Abt Associate's new Risk and Resilience Methods Center, which will work to develop strategies that help people protect themselves against risks—such as illness and financial loss — and improve their ability to respond to these events.

"Preparing people and communities to withstand emergencies is more effective than providing relief once the emergency is over," said Thierry van Bastelaer, principal associate in Abt's International Health division and co-director of the Risk and Resilience Methods Center. "In our work, we are constantly struck by the boundless talents that vulnerable populations bring to managing risk, day after day. They clearly have the skills to manage risk—what they lack are the tools to do it better. While our work serves more than 70 countries and addresses a wide variety of conditions, we are unified by our goal of providing these tools to vulnerable populations."

Risk reduction is focused on reducing the probability of an adverse event, such as losing one's job, which can be partially mitigated by on-the-job training. Resilience deals with people's capacity to reduce the impact associated with an adverse event, such as loss of income from joblessness, which can be partially alleviated by savings and unemployment insurance. 

These concepts are embodied in fields as varied as climate change mitigation, preventative medical treatment, career pathways, homelessness prevention, protection against harmful chemical products, disaster prevention, health insurance, and household asset-building.

"Over the last 45 years, Abt has developed risk and resilience tools in the United States and internationally that span implementation and research, from helping farmers in Bolivia improve their crop yields to designing programs aimed at keeping families from becoming homeless," said Carlos Martin, senior associate in Abt's Social and Economic Policy division and co-director of the Center.

Abt currently implements more than 150 projects that are reducing risk and strengthening peoples' resilience to risk. For example, Abt-led projects are helping HIV-positive men who are unaware of their condition get treatment, making injectable contraceptives more available to young married women in India, and developing private sector health insurance targeted at low-income families.

"This new Center will draw on Abt's rich history and deep expertise to strengthen the science and practice of resilience, which will ultimately  benefit our clients and vulnerable populations in the United States and around the world," said Mark Spranca, vice president of Reputational Capital and Technical Leadership.

About Abt Associates

Abt Associates is a mission-driven, global leader in research and program implementation in the fields of health, social and environmental policy, and international development. Known for its rigorous approach to solving complex challenges, Abt Associates was ranked as one of the top 20 global research firms in 2011 and also named one of the top 40 international development innovators. The company has multiple offices in the U.S. and program offices in nearly 40 countries. www.abtassociates.com

SOURCE Abt Associates

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Source: www.prnewswire.com

ProMedica Joins Cleveland Clinic Innovation Alliance

ProMedica Joins Cleveland Clinic Innovation Alliance

Multi-institutional collaboration aims to accelerate technology development and commercialization

TOLEDO, Ohio, July 30, 2012 /PRNewswire-USNewswire/ -- ProMedica has entered into a collaborative business relationship with Cleveland Clinic as part of a national Innovation Alliance network to help commercialize medical innovations.

ProMedica joins the University of Notre Dame, MedStar Health and North Shore-LIJ as part of a collaborative network focused on identifying and executing joint development and commercialization opportunities for medical innovations.

ProMedica will work directly with Cleveland Clinic Innovations' comprehensive technology and commercialization services ecosystem to identify commercialization opportunities within ProMedica's healthcare system.

A Cleveland Clinic Innovations senior commercialization officer will be dedicated to working with ProMedica to bring new medical innovations to patients.

John Pigott, MD, Medical Director for ProMedica Innovations, will serve as chief liaison for ProMedica, working closely with Cleveland Clinic Innovations.

"Innovation is increasingly becoming a critical institutional priority for ProMedica, and we are looking for new ways to engage our physicians and employees in offering them a pathway to turn their ideas into products and services that meet the needs of our communities," says Lee Hammerling, MD, Chief Medical Officer for ProMedica. "We are excited to be working with Cleveland Clinic, which has a strong history in technology and new venture development, and a proven track record in converting and commercializing medical expertise. "

By employing the same knowledge and resources that have helped it create a reputation as an industry leader in navigating the commercialization process, resulting in 48 spin-off companies and more than 300 licensed technologies, Cleveland Clinic Innovations and its Alliance partners are taking a bold step in what is proving to be a growing trend in health care.

Cleveland Clinic is forming collaborations with universities and health systems to speed up the commercialization of medical innovations. Individually, corporate venturing arms struggle to find the best way to properly utilize their budgets and allocate their limited resources. Collectively, through the Alliance structure, organizations can leverage the experience and expertise of their partners to streamline the process of getting life-saving technologies to patients.

"We look forward to launching this Alliance. ProMedica has a strong commitment to innovation. We believe our collaboration will rapidly benefit patients and will be an important element of our growing national Innovation Alliance network," says Chris Coburn, Executive Director, Cleveland Clinic Innovations. 

An additional benefit of this Innovation Alliance is that through the efforts of innovation and collaboration, the technologies that are commercialized have the potential to create new companies and jobs for the State of Ohio, in addition to improving and extending the lives of patients.

"This partnership is another powerful step toward creating a medical corridor that will benefit Ohioans on so many positive levels," said Mark D. Kvamme, President and Interim Chief Investment Officer for JobsOhio. "Together, Cleveland Clinic Innovations and ProMedica - and other similar, recent collaborations - are laying a foundation to not only better serve patients, but also attract innovative new companies and technologies that lead to more jobs in Ohio."

Toledo, Ohio-based ProMedica is a mission-based, not-for-profit healthcare organization formed in 1986. ProMedica has more than 14,300 employees and nearly 1,700 physicians with more than 400 healthcare providers employed by ProMedica Physicians. Its 11 hospitals and more than 306 facilities offer comprehensive diagnostic, medical and surgical specialties in heart and vascular, oncology, orthopaedics, neurology, and women and pediatric services. ProMedica's mission is to improve health and well-being, with a strong focus on wellness and clinical excellence, as well as innovative, community advocacy programs that address health-related issues such as hunger and obesity. For more information, please visit www.promedica.org.

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, eight community hospitals and 18 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and opening in 2013, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 167,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at www.clevelandclinic.org.  Follow us at www.twitter.com/ClevelandClinic.  

CONTACT: Tedra White, ProMedica, +1-419-262-0371 (cell), tedra.white@promedica.org, or Joe Milicia, Cleveland Clinic, +1-216-636-5873 (office), milicij2@ccf.org

SOURCE ProMedica

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Source: www.prnewswire.com

Billy Connolly – Aroma Therapy

Billy Connolly – Aroma Therapy

– If you would like to learn Reflexology, Color Therapy, Crystal Therapy or Aromatherapy at your own pace in your own home, please visit the

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Free PDF Health Ebook...

Acupressure for Headaches and Neck Tension

    Simply right click the ebook title above, and choose Save As to save to your desktop!  You can find more FREE Natural Health, Wellness and Pet Ebooks at Remedies4.com!


Source: www.natural-holistic-health.com

Sunday, July 29, 2012

Le gouvernement français accepte de financer une étude sur le dispositif de réduction du volume pulmonaire RePneu de PneumRx

Le gouvernement français accepte de financer une étude sur le dispositif de réduction du volume pulmonaire RePneu de PneumRx

- Le gouvernement français engage 1,3 million d'euros pour financer une étude coût/efficacité du LVRC RePneu auprès de 100 sujets dans 10 centres à travers la France

MOUNTAIN VIEW, Californie, le 30 juillet 2012 /PRNewswire/ -- PneumRx, Inc. (www.pneumrx.com), un chef de file dans le domaine de la pneumologie interventionnelle, a annoncé aujourd'hui que le Ministère français de la santé avait approuvé une étude coût/efficacité du dispositif de réduction du volume pulmonaire RePneu (LVRC RePneu) en France. Le Ministère de la santé a accepté de financer l'étude dans le cadre du programme de soutien aux techniques innovantes coûteuses (STIC), qui offre un financement du gouvernement pour des technologies médicales innovantes ayant été validées par des études cliniques antérieures, en vue d'établir le remboursement de nouveaux dispositifs.

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L'étude PneumRx est l'un de seulement deux projets STIC sélectionnés par le Ministère de la santé pour un financement en 2012, et le premier dans le domaine du traitement de l'emphysème depuis 2006. Le gouvernement français s'est engagé à payer 1,3 million d'euros (1,6 million de dollars) pour soutenir cette étude PneumRx. Le protocole, intitulé « Evaluation médico-économique de la réduction volumique par voie endobronchique au moyen de spirales (REVOLENS) », a été soumis par les professeurs Gaëtan Deslee de l'hôpital universitaire de Reims et Charles-Hugo Marquette de l'hôpital universitaire de Nice, le recrutement des patients en France devrait commencer en janvier 2013.

Le système LVRC RePneu est un dispositif mini-invasif visant à améliorer la fonction pulmonaire chez les patients souffrant d'emphysème en implantant par voie bronchoscopique des spirales en Nitinol dans les poumons afin de comprimer les tissus malades (réduction du volume pulmonaire), restaurer le retour élastique et ajuster la compliance pulmonaire. Ce traitement offre une alternative mini-invasive à la chirurgie de réduction du volume pulmonaire à un large éventail de patients atteints d'emphysème.

Le LVRC RePneu a déjà fait l'objet d'études cliniques étendues en Europe, et a affiché des résultats impressionnants dans le cadre de plus de 250 traitements. La majorité des sujets ayant subi un traitement avec le LVRC RePneu dans le cadre des essais cliniques européens de PneumRx ont bénéficié d'une nette amélioration de la fonction pulmonaire, de la capacité d'exercice et de la qualité de vie à la fois 6 mois et un an après le traitement, avec un risque minimal. 74 % de l'ensemble des sujets cliniques ont conservé une amélioration cliniquement significative de la capacité d'exercice 12 mois après le traitement et 96 % ont connu une amélioration significative de leur qualité de vie. Le LVRC RePneu a obtenu le marquage CE en octobre 2010 et il est disponible commercialement dans certains pays d'Europe. PneumRx a également obtenu l'autorisation de la FDA pour démarrer un essai pivot sur 315 sujets aux États-Unis.

« Nous avons constaté une amélioration très importante chez la plupart des patients que nous avons traités avec le LVRC RePneu jusqu'à ce jour, et nous sommes persuadés que les patients que nous recruterons dans cette étude STIC bénéficieront des mêmes avantages, notamment des améliorations de la capacité d'exercice, de la fonction pulmonaire et de la qualité de vie », a déclaré le professeur Gaëtan Deslee, investigateur principal de l'étude. Le professeur Charles-Hugo Marquette a pour sa part déclaré : « Le LVRC RePneu représente une avancée importante dans le traitement des patients souffrant d'emphysème, et nous sommes ravis à l'idée de pouvoir traiter davantage de patients dans le cadre de ce nouveau protocole ».

« Nous sommes enchantés que le gouvernement français ait reconnu les avantages du LVRC RePneu et accepte de soutenir cette étude importante », a fait remarquer Erin McGurk, président et directeur général de PneumRx. « Nous sommes impatients d'apporter les avantages du LVRC RePneu à un nombre toujours plus important de patients atteints d'emphysème en France et à travers le monde ».

À propos de PneumRx, Inc.

PneumRx, Inc. est une société de matériel médical à croissance rapide, qui se concentre sur le développement et la commercialisation de produits innovants pour traiter l'emphysème en utilisant des techniques mini-invasives. PneumRx, Inc. est une société privée implantée à Mountain View, en Californie.

Site Internet

www.pneumrx.com

SOURCE PneumRx, Inc.

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immatics Announces Publication of IMA901 Cancer Vaccine Data in Nature Medicine: Immune Response Associates With Longer Survival

immatics Announces Publication of IMA901 Cancer Vaccine Data in Nature Medicine: Immune Response Associates With Longer Survival

TUEBINGEN, Germany, July 29, 2012 /PRNewswire/ --

Paper highlights clinical and immunological activity of IMA901 in renal cell carcinoma (RCC)

IMA901 is currently being evaluated in a pivotal phase 3 randomized study in patients with RCC

immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer, today announced that key data covering the scientific and clinical development of its lead cancer vaccine, IMA901, have been published in Nature Medicine. The paper highlights that renal cell carcinoma patients experience longer survival times when their immune system produces an immune response to more than one of the peptides in IMA901, the first multi-peptide therapeutic cancer vaccine for RCC.

IMA901 consists of 10 tumor-associated peptides (TUMAPs) confirmed to be naturally presented on tumor cells in patients with renal cell carcinoma (RCC). immatics identified, selected and validated the peptides in IMA901 using its proprietary XPRESIDENTTM platform, which has enabled a uniquely rational approach to cancer vaccine development.  

The Nature Medicine paper reports the findings of two clinical trials with IMA901 in RCC patients. These results are the first showing that naturally presented TUMAPs are clinically relevant in the development of cancer vaccines and can produce meaningful outcomes. In contrast with a number of other cancer vaccine approaches, this research demonstrates that patients who mount a broad anti-tumor immune response experience extended survival.

In another key finding, the researchers identified two serum biomarkers which may help to determine which patients are most likely to achieve an overall survival benefit in future studies with IMA901. The current pivotal phase 3 trial with IMA901 aims to confirm that these two biomarkers are predictive of improved overall survival.

Dr Harpreet Singh, immatics' Chief Scientific Officer and corresponding author of the publication, said: "Having these results published by Nature Medicine is recognition of the rationale behind our development of IMA901 and our other pipeline products. When we formed immatics we were clear that a rational approach to cancer vaccine development was crucial for success. We have been rigorous in following a highly systematic process to identify multiple relevant peptides from primary tumor tissues and then using immunomonitoring and biomarkers to generate and advance IMA901. This journey has produced several novel findings in the cancer immunotherapy field which we believe will advance the development of cancer vaccines and could change the way the disease is managed and treated."

Paul Higham, immatics' Chief Executive Officer, said: "The potential of IMA901 to extend survival times for patients with renal cancer while offering a very good side effect profile is very exciting and offers the potential of real clinical benefit to patients with RCC. Our results so far illustrate the power of our rational approach to cancer vaccine development. We look forward to confirming the positive findings we have generated when we report the results from our on-going pivotal phase 3 trial with IMA901."

The work was performed in close collaboration with a large number of academic institutions, foremost the University of Tuebingen, where the Department of Immunology ‒ led by Prof. Hans-Georg Rammensee, also the originator of the concept behind IMA901 and co-founder of immatics ‒ and the Department of Urology ‒ led by Prof. Arnulf Stenzl, also the Principal Investigator of both clinical trials described in this publication ‒ played a vital role.

About the publication[1]

The Nature Medicine publication summarizes the results of two clinical trials with IMA901 in a total of 96 RCC patients with a number of important clinical findings.

Firstly, these studies show that patients achieve better clinical benefit if they are able to mount immune responses to multiple peptides in the IMA901 vaccine. This confirms the hypothesis that a broad attack of the immune system on multiple targets simultaneously is beneficial.

Additionally, the study demonstrated in a randomized phase 2 trial that a single dose of cyclophosphamide given prior to the first vaccination with IMA901 reduced numbers of regulatory T cells and was associated with a better overall outcome after vaccination with IMA901. Regulatory T cells are thought to counteract the anti-tumor response of cancer vaccines.

The publication also describes the work to identify serum biomarkers to help predict which patients could achieve an overall survival benefit in future studies with IMA901. Through an analysis of over 300 potential biomarkers in pre-treatment samples from the phase 2 study with IMA901, immatics identified two biomarkers, apolipoprotein A-1 and chemokine (C-C motif) ligand 17, that could predict which patients are most likely to achieve longer survival times with IMA901. The current pivotal phase 3 trial with IMA901 aims to validate that these two biomarkers are predictive of improved overall survival.

And finally, for the first time in RCC patients, the clinical relevance of certain types of myeloid-derived suppressor cells, a novel type of regulatory cell counteracting cancer immunotherapy, was described. Sunitinib, the standard first-line therapy in RCC marketed by Pfizer, is combined in the ongoing phase 3 study with IMA901 to decrease numbers of myeloid-derived suppressor cells.

About IMA901

IMA901 is a rationally designed cancer vaccine comprising 10 different tumor-associated peptides (TUMAPs) that are found to be highly over-expressed in the majority of patients suffering from RCC. IMA901 is a peptide-based vaccine with a stable, off-the-shelf formulation and robust and easily scalable manufacturing. IMA901 has completed phase 1 and 2 development in a total of 96 RCC patients and is currently being developed in a pivotal, randomized controlled phase 3 study in combination with sunitinib.

About immatics

immatics biotechnologies is a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer. immatics' lead product, IMA901, is in a pivotal phase 3 study after completing a successful phase 2 trial in renal cell carcinoma. immatics' pipeline also includes IMA910, which has reported improved overall survival data in patients with advanced colorectal cancer, and IMA950, which is in phase 1 in patients with glioma.

immatics' technology platform rapidly generates defined therapeutic cancer vaccines which are based on multiple tumor-associated peptides (TUMAPs) with the ability to specifically stimulate the immune system against cancer cells. These vaccines - comprising multiple peptides confirmed to be naturally presented by real tumor tissue - offer the prospect of greater effectiveness than existing therapeutic approaches combined with fewer side effects. immatics' products are 'drug like' with stable, off-the-shelf formulations and robust easily scalable manufacturing.

immatics is based in Tuebingen and Martinsried (Munich), Germany.

For additional information on immatics please visit http://www.immatics.com or contact:

Paul Higham, CEO
Nikola Wiegeler, Assistant to the Management
immatics biotechnologies GmbH
Phone: +49-7071-5397-110
E-mail: media@immatics.com

Citigate Dewe Rogerson
David Dible / Chris Gardner / Sita Shah
Phone: +44-207-638-9571
E-mail: david.dible@citigatedr.co.uk

1. "Multipeptide immune response to cancer vaccine IMA901 after single-dose cyclophosphamide associates with longer patient survival," Walter S., Weinschenk T. et al. (2012) Nature Medicine. Published online: 29 July 2012  

SOURCE immatics

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immatics Announces Publication of IMA901 Cancer Vaccine Data in Nature Medicine: Immune Response Associates With Longer Survival

immatics Announces Publication of IMA901 Cancer Vaccine Data in Nature Medicine: Immune Response Associates With Longer Survival

TUEBINGEN, Germany, July 29, 2012 /PRNewswire/ --

Paper highlights clinical and immunological activity of IMA901 in renal cell carcinoma (RCC)

IMA901 is currently being evaluated in a pivotal phase 3 randomized study in patients with RCC

immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer, today announced that key data covering the scientific and clinical development of its lead cancer vaccine, IMA901, have been published in Nature Medicine. The paper highlights that renal cell carcinoma patients experience longer survival times when their immune system produces an immune response to more than one of the peptides in IMA901, the first multi-peptide therapeutic cancer vaccine for RCC.

IMA901 consists of 10 tumor-associated peptides (TUMAPs) confirmed to be naturally presented on tumor cells in patients with renal cell carcinoma (RCC). immatics identified, selected and validated the peptides in IMA901 using its proprietary XPRESIDENTTM platform, which has enabled a uniquely rational approach to cancer vaccine development.  

The Nature Medicine paper reports the findings of two clinical trials with IMA901 in RCC patients. These results are the first showing that naturally presented TUMAPs are clinically relevant in the development of cancer vaccines and can produce meaningful outcomes. In contrast with a number of other cancer vaccine approaches, this research demonstrates that patients who mount a broad anti-tumor immune response experience extended survival.

In another key finding, the researchers identified two serum biomarkers which may help to determine which patients are most likely to achieve an overall survival benefit in future studies with IMA901. The current pivotal phase 3 trial with IMA901 aims to confirm that these two biomarkers are predictive of improved overall survival.

Dr Harpreet Singh, immatics' Chief Scientific Officer and corresponding author of the publication, said: "Having these results published by Nature Medicine is recognition of the rationale behind our development of IMA901 and our other pipeline products. When we formed immatics we were clear that a rational approach to cancer vaccine development was crucial for success. We have been rigorous in following a highly systematic process to identify multiple relevant peptides from primary tumor tissues and then using immunomonitoring and biomarkers to generate and advance IMA901. This journey has produced several novel findings in the cancer immunotherapy field which we believe will advance the development of cancer vaccines and could change the way the disease is managed and treated."

Paul Higham, immatics' Chief Executive Officer, said: "The potential of IMA901 to extend survival times for patients with renal cancer while offering a very good side effect profile is very exciting and offers the potential of real clinical benefit to patients with RCC. Our results so far illustrate the power of our rational approach to cancer vaccine development. We look forward to confirming the positive findings we have generated when we report the results from our on-going pivotal phase 3 trial with IMA901."

The work was performed in close collaboration with a large number of academic institutions, foremost the University of Tuebingen, where the Department of Immunology ‒ led by Prof. Hans-Georg Rammensee, also the originator of the concept behind IMA901 and co-founder of immatics ‒ and the Department of Urology ‒ led by Prof. Arnulf Stenzl, also the Principal Investigator of both clinical trials described in this publication ‒ played a vital role.

About the publication[1]

The Nature Medicine publication summarizes the results of two clinical trials with IMA901 in a total of 96 RCC patients with a number of important clinical findings.

Firstly, these studies show that patients achieve better clinical benefit if they are able to mount immune responses to multiple peptides in the IMA901 vaccine. This confirms the hypothesis that a broad attack of the immune system on multiple targets simultaneously is beneficial.

Additionally, the study demonstrated in a randomized phase 2 trial that a single dose of cyclophosphamide given prior to the first vaccination with IMA901 reduced numbers of regulatory T cells and was associated with a better overall outcome after vaccination with IMA901. Regulatory T cells are thought to counteract the anti-tumor response of cancer vaccines.

The publication also describes the work to identify serum biomarkers to help predict which patients could achieve an overall survival benefit in future studies with IMA901. Through an analysis of over 300 potential biomarkers in pre-treatment samples from the phase 2 study with IMA901, immatics identified two biomarkers, apolipoprotein A-1 and chemokine (C-C motif) ligand 17, that could predict which patients are most likely to achieve longer survival times with IMA901. The current pivotal phase 3 trial with IMA901 aims to validate that these two biomarkers are predictive of improved overall survival.

And finally, for the first time in RCC patients, the clinical relevance of certain types of myeloid-derived suppressor cells, a novel type of regulatory cell counteracting cancer immunotherapy, was described. Sunitinib, the standard first-line therapy in RCC marketed by Pfizer, is combined in the ongoing phase 3 study with IMA901 to decrease numbers of myeloid-derived suppressor cells.

About IMA901

IMA901 is a rationally designed cancer vaccine comprising 10 different tumor-associated peptides (TUMAPs) that are found to be highly over-expressed in the majority of patients suffering from RCC. IMA901 is a peptide-based vaccine with a stable, off-the-shelf formulation and robust and easily scalable manufacturing. IMA901 has completed phase 1 and 2 development in a total of 96 RCC patients and is currently being developed in a pivotal, randomized controlled phase 3 study in combination with sunitinib.

About immatics

immatics biotechnologies is a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer. immatics' lead product, IMA901, is in a pivotal phase 3 study after completing a successful phase 2 trial in renal cell carcinoma. immatics' pipeline also includes IMA910, which has reported improved overall survival data in patients with advanced colorectal cancer, and IMA950, which is in phase 1 in patients with glioma.

immatics' technology platform rapidly generates defined therapeutic cancer vaccines which are based on multiple tumor-associated peptides (TUMAPs) with the ability to specifically stimulate the immune system against cancer cells. These vaccines - comprising multiple peptides confirmed to be naturally presented by real tumor tissue - offer the prospect of greater effectiveness than existing therapeutic approaches combined with fewer side effects. immatics' products are 'drug like' with stable, off-the-shelf formulations and robust easily scalable manufacturing.

immatics is based in Tuebingen and Martinsried (Munich), Germany.

For additional information on immatics please visit http://www.immatics.com or contact:

Paul Higham, CEO
Nikola Wiegeler, Assistant to the Management
immatics biotechnologies GmbH
Phone: +49-7071-5397-110
E-mail: media@immatics.com

Citigate Dewe Rogerson
David Dible / Chris Gardner / Sita Shah
Phone: +44-207-638-9571
E-mail: david.dible@citigatedr.co.uk

1. "Multipeptide immune response to cancer vaccine IMA901 after single-dose cyclophosphamide associates with longer patient survival," Walter S., Weinschenk T. et al. (2012) Nature Medicine. Published online: 29 July 2012  

SOURCE immatics

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Source: www.prnewswire.com

Saturday, July 28, 2012

À l'occasion de la Journée mondiale contre l'hépatite, l'EASL invite les Nations Unies à se joindre aux efforts pour s'attaquer au problème de l'hépatite virale

À l'occasion de la Journée mondiale contre l'hépatite, l'EASL invite les Nations Unies à se joindre aux efforts pour s'attaquer au problème de l'hépatite virale

GENÈVE, July 28, 2012 /PRNewswire/ --

Pour marquer la Journée mondiale contre l'hépatite, l'Association européenne pour l'étude du foie (EASL) lance un appel aux différentes organisations faisant partie des systèmes des Nations Unies à agir afin de combattre l'hépatite virale (hépatites B et C), une maladie du foie potentiellement fatale qui affecte 500 millions de personnes. L'hépatite virale provoque le décès de plus d'un million de personnes par an dans le monde, une personne sur trois a été exposée soit au virus de l'hépatite B, soit à celui de l'hépatite C. Ce qui est encore plus inquiétant, c'est que ceux qui sont infectés ne le savent pas[1] et pour eux, la première indication de l'infection peut être le développement d'un cancer du foie ou d'une insuffisance hépatique.

     (Logo: http://photos.prnewswire.com/prnh/20120728/551976 )

L'EASL reconnaît les progrès réalisés ces dernières années, notamment la mise en place du programme mondial contre l'hépatite de l'OMS, et accueille favorablement la publication récente de la stratégie de l'OMS visant à prévenir et contrôler l'infection par l'hépatite virale[2]. Cependant, le professeur Mark Thursz, secrétaire général de l'EASL, a fait remarquer que « l'hépatite virale doit être reconnue comme une menace sérieuse à part entière et des mesures doivent être prises pour empêcher ceux qui ne sont pas encore infectés de le devenir et pour assurer que des traitements soient disponibles pour ceux qui sont infectés ».

L'EASL se lamente de l'impact de l'attention portée exclusivement sur le VIH, la tuberculose et le paludisme dans les politiques issues des Objectifs du Millénaire pour le développement. Dans le cadre des travaux récents qu'il a entrepris récemment en Afrique, le professeur Thursz a rencontré un patient qui lui a dit : « Si je ne contracte pas le VIH rapidement, je vais mourir ». Des médicaments antiviraux vitaux qui sont actifs à la fois contre le VIH et le virus de l'hépatite B sont fournis par le Fonds mondial pour les patients atteints par le VIH, mais ceux touchés par le virus de l'hépatite B n'y ont pas droit. Le professeur Thursz a fait remarquer que « Continuer d'ignorer l'hépatite virale est discriminant et compromettra les réussites en matière de développement durable. Le PNUD devrait accorder à l'hépatite virale la même priorité qu'au HIV, à la tuberculose et au paludisme ».

Le professeur Markus Peck-Radosavljevic, vice-secrétaire de l'EASL, a fait remarquer que « L'hépatite virale est un problème mondial. L'OMS se doit de jouer un rôle plus actif dans la définition de standards pour contrôler la transmission de l'infection par l'entremise d'interventions médicales et de produits sanguins. Il sera difficile d'aborder efficacement le problème de l'épidémie tant que l'OMS n'aura pas établi des protocoles de dépistage et de surveillance dans chaque région ».

Notes au rédacteur:

L'Association européenne pour l'étude du foie (EASL)

L'EASL est la plus importante association européenne dans le domaine du foie. L'EASL compte parmi ses membres les experts les plus en vue dans le secteur de l'hépatologie et jouit d'une réputation excellente dans la promotion de la recherche dans les maladies du foie, dans le soutien à une éducation plus large et dans la promotion de changements dans la politique européenne en faveur du foie.

L'EASL pense que l'UE a un rôle clé à jouer pour développer la sensibilisation aux maladies hépatiques en Europe, allouer des financements additionnels en faveur de la recherche, définir des standards et des lignes directrices pour la prévention, le diagnostic, le traitement et les soins des maladies hépatiques à travers l'UE et encourager les États membres à accorder aux maladies hépatiques une priorité de recherche et de santé publique.

Pour plus d'informations, veuillez consulter le site http://www.easl.eu

À propos des maladies hépatiques

Les maladies hépatiques, dont on estime qu'elles affectent 6 % de la population de l'UE (environ 29 millions de personnes), représenteraient la cinquième cause de décès dans l'UE, avec au moins un décès sur six. En 2004, le taux de mortalité pour les maladies hépatiques chroniques était estimé à 14,3 cas pour 100 000 dans l'Europe des 25. Cela veut dire que plus de 70 000 européens meurent d'une maladie hépatique chronique chaque année. Encore plus inquiétant est le fait que les statistiques de l'UE n'intègrent pas l'ensemble des maladies hépatiques dans une même catégorie, par ex. les décès liés à l'abus d'alcool et les cancers du foie sont comptabilisés séparément. Par conséquent, le taux réel de décès liés à des maladies hépatiques est certainement bien plus élevé que ce que pourraient laisser penser les statistiques.

L'hépatite est une inflammation du foie, provoquée le plus souvent par une infection virale. Il existe cinq types principaux de virus hépatiques, connus sous les noms de types A, B, C, D et E. Ces cinq types sont l'objet de préoccupations importantes à cause de la charge en maladies et en décès dont ils sont responsables et du potentiel d'apparition de poussées et d'épidémies. En particulier, les types B et C aboutissent à des maladies chroniques chez des centaines de millions de personnes et, ensemble, représentent la cause la plus courante de cirrhose et de cancer du foie.

1. http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/hepatitis/facts-and-figures

2. http://www.who.int/csr/disease/hepatitis/en/

SOURCE The European Association for the Study of the Liver (EASL)

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EASL ruft zum Welt-Hepatitis-Tag die Vereinten Nationen auf, sich auch im Kampf gegen virale Hepatitis zu engagieren

EASL ruft zum Welt-Hepatitis-Tag die Vereinten Nationen auf, sich auch im Kampf gegen virale Hepatitis zu engagieren

GENF, July 28, 2012 /PRNewswire/ --

Anlässlich des Welt-Hepatitis-Tages rief die European Association for the Study of the Liver (EASL) die unterschiedlichen Organisationen innerhalb des Systems der Vereinten Nationen dazu auf, den Kampf gegen die virale Hepatitis (Hepatitis B und C) aufzunehmen, eine potenziell tödliche Infektion der Leber, von der 500 Millionen Menschen betroffen sind. Virale Hepatitis kostet jedes Jahr mehr als eine Million Menschenleben, und weltweit waren einer von drei Menschen entweder dem Hepatitis B- oder dem Hepatitis C-Virus bereits ausgesetzt. Noch beunruhigender ist, dass die Infizierten sich dieser Tatsache nicht bewusst sind[1] und das erste Anzeichen der Infektion, das sie bemerken, die Entstehung von Leberkrebs oder Leberversagen sein kann.

     (Logo: http://photos.prnewswire.com/prnh/20120728/551976 )

Die EASL ist sich darüber bewusst, dass in den letzten Jahren Fortschritte erzielt wurden, unter anderem durch die Einführung des weltweiten Hepatitisprogramms der Weltgesundheitsorganisation WHO, und zeigt sich erfreut über die kürzlich veröffentlichte WHO-Strategie zur Vermeidung und Kontrolle von Infektionen mit viraler Hepatitis[2]. Dennoch stellte Professor Mark Thursz, der Generalsekretär der EASL, fest, dass "virale Hepatitis als ernsthafte Bedrohung anerkannt werden muss und Maßnahmen getroffen werden müssen, um die noch nicht Infizierten vor einer Ansteckung zu schützen und sicherzustellen, dass die, die bereits infiziert sind, behandelt werden."

Die EASL beklagt die Auswirkungen der ausschließlichen Konzentration auf HIV, Tuberkulose und Malaria in den aus den Millennium-Entwicklungszielen hervorgegangenen Richtlinien. Bei seiner Arbeit in Afrika in der jüngeren Vergangenheit traf Prof. Thursz einen Patienten, der zu ihm sagte: "Wenn ich mich nicht bald mit HIV anstecke, sterbe ich." Der Globale Fonds stellt HIV-positiven Patienten lebensrettende antivirale Medikamente zur Verfügung, die sowohl gegen HIV als auch gegen HBV wirksam sind, Patienten, die mit dem Hepatitis B-Virus infiziert sind, jedoch nicht. Prof. Thursz bemerkte dazu: "Virale Hepatitis weiterhin zu ignorieren, ist diskriminierend und setzt im Sinne einer nachhaltigen Entwicklung bereits Erreichtes wieder aufs Spiel. Das Entwicklungsprogramm der Vereinten Nationen UNDP sollte der viralen Hepatitis ebenso viel Bedeutung beimessen wie HIV, Tuberkulose und Malaria."

Prof. Markus Peck-Radosavljevic, der Vizesekretär der EASL, meint dazu: "Virale Hepatitis ist ein weltweites Problem. Es ist unerlässlich, dass die WHO eine aktivere Rolle bei der Festlegung von Standards zur Eindämmung der Ansteckung mit der Krankheit bei medizinischen Behandlungen und durch Blutprodukte übernimmt. Solange die WHO nicht in allen Regionen Untersuchungs- und Überwachungsprotokolle etabliert hat, wird es schwierig werden, wirkungsvolle Maßnahmen gegen die Epidemie zu ergreifen."

Redaktionshinweise:

Die European Association for the Study of the Liver (EASL)

Die EASL ist die führende Gesellschaft zur Erforschung der Leber in Europa. Zu den Mitgliedern der EASL gehören führende Fachleute für Hepatologie, und die Gesellschaft hat bei der Förderung der Erforschung von Lebererkrankungen, einer umfassenden Aufklärung und dem Herbeiführen von Änderungen in der europäischen Politik im Bezug auf Leberkrankheiten bereits beeindruckende Erfolge erzielt.

Die EASL glaubt, dass die EU eine Schlüsselrolle dabei spielen sollte, das Bewusstsein für Leberkrankheiten in Europa zu verbessern, EU-weite Standards und Leitsätze für die Vorbeugung, Diagnose, Behandlung und Pflege bei Leberkrankheiten festzulegen und die Mitgliedsstaaten dazu zu bringen, Lebererkrankungen im Gesundheitswesen und in der Forschung mehr Priorität zu verleihen.

Weitere Informationen finden Sie auf der Website http://www.easl.eu

Informationen zu Lebererkrankungen

Lebererkrankungen betreffen schätzungsweise 6 % der Bevölkerung der EU (ca. 29 Millionen Menschen) und sind für einen von sechs Todesfällen verantwortlich. Sie stellen somit die fünfthäufigste Todesursache in der EU dar. 2004 lag die Sterblichkeitsrate für chronische Lebererkrankungen bei geschätzten 14,3 Todesfällen pro 100.000 Einwohner der 25 EU-Länder. Das bedeutet, dass mehr als 70.000 Europäer jährlich an chronischen Lebererkrankungen sterben. Noch besorgniserregender ist die Tatsache, dass die EU-Statistiken nicht alle Erkrankungen der Leber in einer Kategorie erfassen, z. B. werden Todesfälle in Verbindung mit Alkoholmissbrauch anders behandelt als Leberkrebs. Daher ist die tatsächliche, durch Lebererkrankungen verursachte Sterblichkeitsrate sicherlich deutlich höher, als die Statistiken vermuten lassen.

Hepatitis ist eine Leberentzündung, die in den meisten Fällen durch eine Virusinfektion hervorgerufen wird. Es gibt fünf Haupttypen des Hepatitisvirus, die als Typ A, B, C, D und E bezeichnet werden. Diese fünf Typen bieten den meisten Grund zur Besorgnis, weil sie schwere Erkrankungen und sogar Todesfälle verursachen und das Potenzial für Ausbrüche epidemischen Ausmaßes haben. Vor allem die Typen B und C haben bei mehreren Hundert Millionen Menschen zu chronischen Erkrankungen geführt und gemeinsam sind sie die häufigste Ursache für Leberzirrhose und -krebs.

1. http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/hepatitis/facts-and-figures

2. http://www.who.int/csr/disease/hepatitis/en/

SOURCE The European Association for the Study of the Liver (EASL)

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La EASL insta a las Naciones Unidas a unir sus esfuerzos para abordar la hepatitis vírica

La EASL insta a las Naciones Unidas a unir sus esfuerzos para abordar la hepatitis vírica

GINEBRA, July 28, 2012 /PRNewswire/ --

    - Con ocasión del Día Mundial de la Hepatitis, la EASL insta a las Naciones Unidas a unir sus esfuerzos para abordar la hepatitis vírica

Como conmemoración del Día Mundial de la Hepatitis, la European Association for the Study of the Liver (EASL) insta a las diversas organizaciones que componen los sistemas de las Naciones Unidas a poner en marcha acciones para luchar contra la hepatitis vírica (hepatitis B y C), una infección potencialmente mortal del hígado que afecta a 500 millones de personas. La hepatitis vírica es la causa de fallecimiento de más de 1 millón de personas al año, y en todo el mundo, una de cada 3 personas está expuesta al virus de la hepatitis B o al virus de la hepatitis C. Y lo que aún preocupa más, los que están infectados no conocen estos datos[1], y para ellos la primera indicación de infección puede ser el desarrollo de cáncer de hígado o fallo hepático.

     (Logo: http://photos.prnewswire.com/prnh/20120728/551976 )

La EASL reconoce el progreso realizado en los últimos años, incluyendo la creación del Global Hepatitis Programme de la OMS, y da la bienvenida a la reciente publicación de la estrategia de la OMS para la prevención y control de las infecciones de hepatitis vírica[2]. A pesar de ello, el profesor Mark Thursz, secretario general de la EASL, explicó: "La hepatitis vírica necesita recibir el reconocimiento como una amenaza seria en sí misma, y se deben tomar medidas para prevenir que los que aún no están infectados se contagien y poder asegurar el tratamiento disponible para los que están infectados".  

La EASL lamenta el impacto del énfasis exclusive del VIH, TB y malaria en las políticas que han surgido de los Objetivos de Desarrollo del Milenio. Como parte del trabajo que ha realizado recientemente en África, el profesor Thursz se reunió con un paciente que le dijo: "Si no me contagio de VIH en breve moriré". Los medicamentos antivirales que salva vidas y que funcionan contra el VIH y la HBV son suministrados por medio del Global Fund para los pacientes que padecen VIH, pero son denegados para los pacientes con HBV. El profesor Thursz remarcó: "Continuar ignorando la hepatitis vírica es discriminador, y comprometerá los logros dentro del desarrollo sostenible. UNDP deberá dar a la hepatitis vírica la misma prioridad que al VIH, TB y la malaria".

El profesor Markus Peck-Radosavljevic, vicesecretario de la EASL, explicó: "La hepatitis viral es un problema global. Necesitamos que la OMS lleve a cabo un papel más activo para establecer los estándares de control de la transmisión de la infección por medio de las intervenciones médicas y de los productos de sangre. Será complicado hacer frente a esta epidemia de forma efectiva hasta que la OMS cree los protocolos de control y vigilancia en cada región".

Notas para los redactores:

La European Association for the Study of the Liver (EASL)

La EASL es la principal asociación del hígado en Europa. La EASL atrae a los expertos hepatólogos más destacados como miembros, y dispone de un impresionante registro de seguimiento en la promoción de la investigación de la enfermedad hepática, apoyando una formación más amplia y promoviendo los cambios dentro de la política europea sobre el hígado.

La EASL cree que la UE posee un papel vital para aumentar la concienciación en torno a la enfermedad hepática en Europa, aumentando los fondos adicionales para investigación, estableciendo estándares y directrices para la prevención, diagnosis, tratamiento y cuidado de la enfermedad hepática a través de la UE e instando a los estados miembro a hacer de la enfermedad del hígado una prioridad dentro de la salud pública y la investigación.  

Para más información visite http://www.easl.eu

Acerca de la enfermedad hepática

La enfermedad hepática, que se estima afecta a un 6% de la población de la UE (unos 29 millones de personas), es el quinto mayor asesino de la UE, contabilizando al menos uno de cada seis fallecimientos. En el año 2004, la tasa de mortalidad para las enfermedades hepáticas crónicas se estimaba en un 14,3% por cada 100.000 personas en los 25 países de la UE. Esto significa que más de 70.000 europeos fallecen a consecuencia de una enfermedad relacionada con el hígado cada año. Y lo que es más preocupante es que las estadísticas de la UE no cubren todas las enfermedades del hígado dentro de una categoría, por ejemplo, los fallecimientos relacionados con el abuso del alcohol y el cáncer de hígado se tratan de forma separada. Por ello, la tasa actual de muertes a consecuencia de enfermedad hepática es mucho mayor que lo que se indica en las estadísticas.

La hepatitis es una inflamación del hígado, que suele darse principalmente por una infección vírica. Hay cinco tipos principales de virus de hepatitis, indicados como de tipo A, B, C, D y E. Estos 5 tipos son los que más preocupan, debido a la carga de la enfermedad y el fallecimiento que producen y al potencial de brotes y de propagación epidémica. En concreto, los tipos B y C levan a una enfermedad crónica en cientos de millones de personas, y de forma conjunta, son la causa más habitual de cirrosis hepática y cáncer.

1. http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/hepatitis/facts-and-figures

2. http://www.who.int/csr/disease/hepatitis/en/

SOURCE The European Association for the Study of the Liver (EASL)

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Friday, July 27, 2012

Colorado Ruling Endangers Women's Health

Colorado Ruling Endangers Women's Health

Catholics Demand Respect for Employees' Consciences

WASHINGTON, July 27, 2012 /PRNewswire-USNewswire/ -- A Federal District Court in the District of Colorado ruled today that a private air-conditioning manufacturer can discriminate against its employees and refuse to cover contraception as required by the Affordable Care Act.

Catholics for Choice is dismayed by the injunction in favor of Hercules Industries, a for-profit, private, heating and air conditioning company owned by a Catholic family. The injunction allows the company's executives to deny affordable coverage to employees for contraceptive services and counseling as required by new federal regulations going into effect next Wednesday. This exemption constitutes court-sanctioned discrimination against Hercules' employees by allowing its executives' personal objections to contraception to trump their employees' own beliefs and consciences. The judge stated that this ruling only applied to Hercules, but there is no guarantee that other cases and other judges will extend the ruling more broadly.

Jon O'Brien, the president of Catholics for Choice said, "The bishops and their representatives have stated from the beginning that they will not rest until every institution—religious, secular, for-profit, non-profit, 'Taco Bell' or Catholic diocese—is allowed to refuse contraceptive coverage to its employees. This ruling demonstrates just how far the Catholic hierarchy and its conservative allies are willing to go in their quest to eliminate contraceptive coverage for all people. Some believe that caving to the bishops by allowing employers at certain 'religious institutions' was merely a commonsense, thoughtful compromise. Some likewise believe that granting an additional accommodation to Catholic hospitals or universities would be similarly reasonable. As these suits demonstrate, however, the bishops and their allies will never be satisfied with the miles they've already been given; they will not rest until every single worker must ask their bosses for permission to access affordable, sometimes life-saving contraceptive coverage."

Catholics for Choice shapes and advances sexual and reproductive ethics that are based on justice, reflect a commitment to women's well-being and respect and affirm the capacity of women and men to make moral decisions about their lives.

SOURCE Catholics for Choice

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American Realty Capital Healthcare Trust Acquires Aurora Health Care Portfolio in Wisconsin for $63 Million

American Realty Capital Healthcare Trust Acquires Aurora Health Care Portfolio in Wisconsin for $63 Million

NEW YORK, July 27, 2012 /PRNewswire/ -- American Realty Capital Healthcare Trust, Inc.  ("ARC Healthcare") announced today that it has closed the acquisition of three medical office buildings 100% leased to Aurora Health Care.  The buildings are located in Two Rivers, Wisconsin, Hartford, Wisconsin and Neenah, Wisconsin, and were purchased for $63.0 million, exclusive of closing costs.  Aurora Health Care is a not-for-profit healthcare system that operates 15 hospitals and employs over 1,500 physicians treating 1.2 million individual patients annually across 31 counties in Wisconsin and Illinois.  Certain of Aurora Health Care, Inc.'s senior bonds carry an investment grade credit rating as determined by a major credit rating agency.

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The Aurora Health Care portfolio contains 226,046 rentable square feet of space providing various outpatient services within each building including urgent care, pharmacy services, clinical space, rehabilitation and physical therapy.  The acquisition of the Aurora portfolio increases the total size of ARC Healthcare's portfolio to $409.7 million, comprising 34 properties.

Since the end of Q1 2012, consistent with its investment strategy, ARC Healthcare has closed on the acquisition of 15 properties for an aggregate purchase price of $214.5 million.  The properties, located in eleven states, consist of 12 medical office buildings, two life-science buildings and one hospital, totaling 752,638 square feet.  The 15 properties are 98.9% leased on a weighted average basis with an average of 12.1 years remaining on the primary lease terms. 

"We are very pleased to complete the acquisition of these three high-quality, recently constructed medical office buildings leased and operated by one of the largest and most reputable healthcare systems in the state of Wisconsin, Aurora Health Care," said Tom D'Arcy, chief executive officer of American Realty Capital Healthcare Advisors, LLC.  "As we effectively deploy our capital, these properties add to our diversified portfolio, focused on healthcare assets leased to strong national and regional operators on a long-term basis."

Important Notice

ARC Healthcare is a publicly registered, non-traded real estate investment program.

ARC Healthcare initially filed a registration statement on Form S-11 (including a prospectus) with the Securities and Exchange Commission ("SEC") on August 27, 2010, and the registration statement became effective on February 18, 2011. This communication relates to such offering. Before you invest, you should read the prospectus in that registration statement and other documents that the Company has filed with the SEC for more complete information about the Company and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. The final prospectus, as reprinted on July 24, 2012, is available on the SEC Web site at: http://sec.gov/Archives/edgar/data/1499875/000114420412040762/v319158_424b3.htm.  

Alternatively, the Company or Realty Capital Securities, LLC, the dealer manager participating in the offering, or any other dealer participating in the offering will arrange to send you the prospectus and/or supplements thereto if you request them by calling toll-free 1-877-373-2522.

SOURCE American Realty Capital Healthcare Trust, Inc.

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Mustard Health Benefits

Mustard Health Benefits

One of my favorite condiments is organic Dijon mustard. I slather it on most of my sandwiches – peanut butter and jelly not withstanding. As with most of my other culinary and dietary choices, my decision to use this ingredient is based on the fact that I enjoy the flavor, while hopeful that it will impart certain benefits. If you’ve never thought of mustard as a health promoting ingredient, then please read on.

First things first. The ingredients in your mustard matter. The product I use, which shall remain nameless, is pretty pure and straightforward. It only contains four familiar components: organic mustard seeds, organic vinegar, water and sea salt. And, best of all, you can taste every single ingredient. This mustard has some serious kick to it!

There haven’t been many clinical, human studies published about mustard. In fact, most of the clinical data about mustard has looked into its potential to protect against various malignancies in animals. A little known fact about mustard is that it’s a member of the Brassica family. Vegetables such as broccoli, cabbage and kale are more familiar members of this very same family of plants. Brassicas, including mustard, contain a class of phytochemicals known as glucosinolates and enzymes which convert these chemoprotective substances into even more powerful phytochemicals (isothiocyanates). In rat models of disease, mustard seeds have been shown to discourage the growth of colon, stomach and uterine cancer. Preliminary studies also reveal that dietary mustard improves insulin sensitivity, oxidative stress and unhealthy lipid profiles. These findings suggest, but do not prove, that mustard may be beneficial with regard to some of the most prevalent diseases of today such as diabetes, heart disease and metabolic syndrome.

Two recent human trials have, likewise, spurred new interest in the use of mustard as a bona fide health food. The first, presented in the December 2011 issue of the journal Mutation Research/Genetic Toxicology and Environmental Mutagenesis, reports that mustard consumption protects against DNA damage – an integral stage in cancer development. While a just published study goes on to explain that including 21 grams of mustard in a meal increases the amount of calories burned, a process referred to as diet-induced thermogenesis. All of this is not to say that mustard ought to used as an excuse to overindulge in nitrate-laden hot dogs stuffed in refined buns and drenched in ketchup containing high fructose syrup. But, given a more reasonable context, such as a mustard vinaigrette, this is one condiment that seems like a terrific option indeed.

To learn more about the studies referenced in today’s column, please click on the following links:

Study 1 - Dietary Mustard Seeds (Sinapis alba Linn) Suppress (link)

Study 2 - Mustard seeds (Sinapis Alba Linn) Attenuate Azoxymethane (link)

Study 3 - Novel Mucilage Fraction of Sinapis Alba L. (Mustard) Reduces (link)

Study 4 - Chemopreventive Effects of Mustard (Brassica Compestris) on (link)

Study 5 - Brassica Juncea (Rai) Significantly Prevented the Development of (link)

Study 6 – Effect of Feeding Murraya Koeingii and Brassica Juncea Diet (link)

Study 7 – Anti-Oxidant Effects of Curry Leaf, Murraya Koenigii and Mustard (link)

Study 8 - Biochemical Response in Rats to the Addition of Curry Leaf (Murraya (link)

Study 9 - Isothiocyanate-Containing Mustard Protects Human Cells Against (link)

Study 10 - Acute Effects of Mustard, Horseradish, Black Pepper and Ginger on (link)

Brassica Vegetables May Protect Against DNA Damage

Source: Mutagenesis. 2010 Nov;25(6):595-602. (link)

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Source: www.healthyfellow.com

Aethlon Medical Announces the Appointment of Thomas V. Wornham and Philip A. Ward to its Board of Directors

Aethlon Medical Announces the Appointment of Thomas V. Wornham and Philip A. Ward to its Board of Directors

SAN DIEGO, July 27, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today announced the appointment of Thomas V. Wornham and Philip A. Ward to its board of directors.  "We are honored to have Tom and Phil join our board. Their wealth of business experience will be instrumental in guiding the future growth and achievement of our organization," stated Aethlon Chairman & CEO Jim Joyce.

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Mr. Wornham recently retired as Executive Vice President & Regional Manager at Wells Fargo Bank in San Diego, representing the culmination of an exemplary career that spanned three decades.  At Wells Fargo, Tom's team provided financial solutions to diverse industry organizations whose annual revenues ranged between $10 million to $1 billion dollars.  Included among these organizations were public and private life science, biotechnology and medical device companies located throughout San Diego, Imperial, and Southern Riverside Counties.  Mr. Wornham is also an active civic leader.  He is currently Vice Chairman of the San Diego Water Authority and the past Chairman of the San Diego Regional Chamber of Commerce, The Century Club of San Diego, and the San Diego Regional Economic Development Corporation.  Mr. Wornham graduated from University of California Berkeley, with a BA Political Science.

"This is a tremendous opportunity for me to work with Jim and his team," stated Mr. Wornham.  "I am excited to be part of a group committed to developing technology that I hope will improve the quality of peoples lives."

Mr. Ward is the former Chairman and CEO, Bignell-Ward-Bignell Corporation; former President and CEO, Hawk Financial Services Corporation, A premium finance company; Former Executive Director and COO of Investments, Golden Eagle Insurance Corporation, a property and casualty California insurance company; and former Executive Vice President and COO Finance at Big Bear Supermarkets, where he was also in charge of acquisitions, as well as leasing and sales of all operating units and real properties.

"I believe in the vision of Aethlon Medical and I look forward to contributing my business acumen to the benefit of shareholders," stated Mr. Ward.

About Aethlon Medical

The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.

Certain statements herein may be forward-looking and involve risks and uncertainties.  Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies or as a standalone cancer therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com

Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com

Marc Robins
877.276.2467
mr@aethlonmedical.com

SOURCE Aethlon Medical, Inc.

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Treatment Options For Ezcema

Eczema has a nasty way of drying out your skin. That means the most upfront way of eczema treatment is to bring back all the moisture it lost, is still losing. But we all know that the moisturizers we see on flashing commercial ads will not do the job. As some people who have tried them for eczema treatments said, those products do not even work skin-deep.

There is a form of eczema treatment which does not require the patient suffering from the skin disease to take medications. It’s called phototherapy or light therapy – a treatment for certain skin conditions using artificial light wavelengths from the sun’s ultraviolet spectrum.

As much as possible, when your skin is irritated avoid making it worse by scratching. The trick here is to cover it with a dressing or by wearing thick gloves that can lessen the damage from scratching. If you find that you can’t control yourself from scratching that annoying itch, then try to do as lightly as possible or finding ways to protect your skin from self-abrasion.

There are several forms in which corticosteroids are utilized for the treatment of eczema. They may be in topical forms, the kind of preparations applied onto the skin – ointments, lotions, creams and foams. These kinds of corticosteroids preparations are often used for mild to moderate inflammation of the eczematous skin.

Should I Use Neosporin On Cold Sores

Thursday, July 26, 2012

Eisai ha ottenuto l'autorizzazione all'immissione in commercio di Fycompa® (perampanel)

Eisai ha ottenuto l'autorizzazione all'immissione in commercio di Fycompa® (perampanel)

HATFIELD, Inghilterra, July 27, 2012 /PRNewswire/ --

È la prima autorizzazione a livello globale per questa nuova classe di trattamenti per l'epilessia

L'Agenzia europea per i medicinali (EMA) ha emesso oggi l'autorizzazione all'immissione in commercio per l'uso di Fycompa® (perampanel) come terapia aggiuntiva per il trattamento delle crisi epilettiche parziali, con o senza generalizzazione secondaria, nei pazienti con epilessia di età pari o superiore a 12 anni.[1] In seguito all'approvazione nell'UE, l'Unione Europea rappresenta la prima regione al mondo ad ottenere l'autorizzazione per l'immissione in commercio del perampanel, molecola sviluppata da Eisai.

Scoperto e sviluppato da Eisai in Europa e Giappone, il perampanel è attualmente l'unico farmaco antiepilettico (FAE) approvato che agisce in modo selettivo sui recettori AMPA, i quali hanno un ruolo centrale nella generazione e nella diffusione delle crisi epilettiche.[2] Le crisi epilettiche sono causate principalmente dal neurotrasmettitore glutammato.[3] Come antagonista del recettore AMPA, il perampanel agisce sulle crisi epilettiche bloccando gli effetti del glutammato. Questo meccanismo d'azione è diverso da quello dei FAE disponibili sul mercato e rende il perampanel il primo prodotto di una nuova classe di farmaci.[4, 5] Il perampanel è il primo trattamento con efficacia clinica dimostrata in studi clinici di fase III contro le crisi epilettiche parziali, bloccando selettivamente (in modo non competitivo) la neurotrasmissione eccitatoria mediata dai recettori AMPA a livello post-sinaptico.[6, 7] Perampanel a livello mondiale sarà prodotto e confezionato presso la sede centrale EMEA di Eisai (Europa, Medio Oriente, Africa e Russia) di Hatfield, nel Regno Unito. Inoltre, il Regno Unito sarà il primo paese a lanciare il perampanel a settembre 2012.

"Il migliore controllo delle crisi epilettiche rappresenta una delle esigenze più importanti per il trattamento dei pazienti epilettici. L'approvazione europea del perampanel è un evento di rilevanza, poiché rappresenta un'opzione terapeutica assolutamente nuova per i medici da utilizzare nella lotta contro le crisi epilettiche non controllate. La comunità di esperti in epilessia attende con grande interesse la disponibilità di un farmaco antiepilettico decisamente innovativo", ha commentato il Professor Bernhard Steinhoff, Professore di neurologia, direttore sanitario e direttore del Centro per l'epilessia di Kehl-Kork, in Germania.

Si ritiene che in Europa vi siano circa sei milioni di persone affette da epilessia[8] e il successo del trattamento delle crisi epilettiche parziali (il tipo più comune di epilessia) in alcuni pazienti rimane al momento una sfida. L'incidenza dell'epilessia non controllata rimane elevata nonostante il notevole numero di nuovi FAE disponibili ed è stato stimato che circa il 20-40% dei pazienti con epilessia di nuova diagnosi diventa refrattario al trattamento.[9]

L'UE ha basato la decisione di autorizzare questo farmaco sui dati clinici ottenuti da tre studi pilota di fase III, globali, randomizzati, in doppio cieco, con progressione di dosaggio e controllati vs placebo condotti in 1.480 pazienti con epilessia. Ogni studio ha dimostrato risultati simili per quanto riguarda l'efficacia e la tollerabilità del perampanel come terapia aggiuntiva nei pazienti con crisi epilettiche parziali (con o senza generalizzazione secondaria).[7, 10, 11] Inoltre, il perampanel offre il vantaggio della somministrazione una volta al giorno, riducendo il numero potenziale di assunzioni giornaliere nei pazienti con epilessia.[12] Gli eventi avversi più frequentemente riferiti sono stati capogiri, cefalea, sonnolenza, irritabilità, affaticamento, cadute e atassia.[7, 10, 11]

Il perampanel ha ottenuto il parere positivo dal Comitato per i medicinali per uso umano (Committee for Medicinal Products for Human Use, CHMP) dell'Agenzia europea dei medicinali (EMA) a maggio 2012. Inoltre, la Food and Drug Administration (FDA) statunitense ha accettato la New Drug Application per il perampanel a marzo 2012.

Lo sviluppo del perampanel rinforza la missione di Eisai di fornire assistenza sanitaria umana (hhc, human health care), l'impegno dell'azienda nella scoperta di soluzioni innovative per la prevenzione delle malattie, nella cura e nella salute e il benessere delle persone a livello mondiale. Eisai è impegnata nell'area terapeutica dell'epilessia e a rispondere alle esigenze mediche non soddisfatte dei pazienti con epilessia e dei loro familiari. Eisai è fiera di avere attualmente immesso sul mercato EMEA un numero di prodotti per l'epilessia maggiore di qualsiasi altra azienda.

Note per gli editori

Informazioni sul perampanel

Eisai ha sviluppato il perampanel come terapia aggiuntiva per il trattamento delle crisi parziali, con o senza generalizzazione secondaria, nei pazienti con epilessia di età pari o superiore a 12 anni. Il perampanel è un antagonista non competitivo dei recettori del glutammato (acido α-amino-3-idrossi-5-metil-4-isossazolpropionico) di tipo AMPA con effetti anticonvulsivi dimostrati in studi di fase II e III. I recettori AMPA, ampiamente presenti in quasi tutti i neuroni eccitatori, trasmettono i segnali stimolati dal glutammato, un neurotrasmettitore eccitatorio presente nel cervello. Si ritiene che questi recettori partecipino allo sviluppo di alcune malattie del sistema nervoso centrale caratterizzate da un'eccessiva neuroeccitazione, tra le quali l'epilessia, i disordini neurodegenerativi, i disordini motori, il dolore e i disordini psichiatrici. Il perampanel è il primo prodotto di questa classe di farmaci per il trattamento aggiuntivo delle crisi epilettiche parziali, con o senza generalizzazione secondaria, nei pazienti epilettici di età pari o superiore a 12 anni.

Informazioni sugli studi di fase III sul perampanel (studi 306, 305 e 304)

Il piano per lo sviluppo clinico del perampanel consisteva in tre studi globali di fase III, gli studi 306, 305 e 304, a cui hanno partecipato 1.480 pazienti. L'obiettivo principale dello studio 306 era l'identificazione della dose efficace minima e includeva quattro bracci di trattamento (placebo, 2 mg, 4 mg, e 8 mg). Gli studi 304 e 305 includevano tre bracci (placebo, 8 mg e 12 mg) e avevano l'obiettivo di valutare un intervallo terapeutico più ampio.

Gli studi erano stati progettati in modo simile ed erano studi globali, randomizzati, in doppio cieco, controllati con placebo, con progressione di dosaggio e a gruppi paralleli. Gli endpoint primari e secondari erano gli stessi in tutti gli studi: variazione percentuale nella frequenza delle crisi, tasso di responder del 50%, percentuale di riduzione delle crisi parziali complesse e delle crisi con generalizzazione secondaria e valutazione della risposta in base alla dose. L'endpoint primario per l'EMA è rappresentato da un tasso di responder del 50%, mentre per l'FDA è la variazione percentuale mediana nella frequenza delle crisi.

Studio 306[7]- Australia, Bulgaria, Cina, Repubblica Ceca, Germania, Spagna, Estonia, Hong Kong, Ungheria, India, Italia, Corea del Sud, Lituania, Lettonia, Malesia, Filippine Polonia, Portogallo, Romania, Russia, Serbia e Montenegro, Thailandia, Taiwan e Ucraina

Lo studio 306 ha dimostrato che il perampanel era ben tollerato ed efficace nel ridurre la frequenza mediana delle crisi e nell'aumentare il tasso di responder. In particolare, i risultati hanno dimostrato quanto segue:

  • I tassi di responder del 50% rispetto al placebo per la popolazione ITT (intention-to-treat) erano: 2 mg = 20,6% (p=ns), 4 mg = 28,5% (p=0,0132) e 8 mg = 34,9% (p<0.001) rispetto al 17,9% con il placebo
  • La variazione percentuale mediana nella frequenza delle crisi per la popolazione ITT era: 2 mg = -13,6% (p=0,4197), 4 mg = -23,3% (p=0,003), 8 mg = -30,8% (p<0,0001) rispetto al -10,7% con placebo
  • Gli eventi avversi associati al trattamento più comunemente evidenziati comprendevano capogiri, sonnolenza e cefalea.

Studio 305[11]- Austria, Finlandia, Australia, Belgiio, Germania, Francia, Gran Bretagna, Grecia, India, Israele, Paesi Bassi Italia, Russia, Svezia, Stati Uniti e Sud Africa

L'endpoint primario era una differenza significativa della variazione percentuale mediana nella frequenza delle crisi con perampanel 8 mg e 12 mg. In particolare, i risultati preliminari dello studio 305 hanno dimostrato quanto segue:

  • I tassi di responder del 50% rispetto al placebo per la popolazione ITT erano: 8 mg = 33,3% (p=0.0018), 12 mg = 33,9% (p<0.001) rispetto al 14,7% con il placebo
  • La variazione percentuale mediana nella frequenza delle crisi per la popolazione ITT era: 8 mg = -30,5% (p<0.001), 12 mg = -17,6% (p=0.011) rispetto al -9,7% con il placebo
  • Gli eventi avversi più comunemente evidenziati comprendevano capogiri, sonnolenza, affaticamento e cefalea

Studio 304[10]- Stati Uniti, Canada, Messico, Cile, Argentina

Lo studio 304 ha dimostrato risultati costanti riguardo l'efficacia e la tollerabilità del perampanel per il trattamento di pazienti con crisi epilettiche parziali. In particolare:

  • I tassi di responder del 50% rispetto al placebo per la popolazione ITT erano: 8 mg = 37,6% (p=0,0760), 12 mg = 36,1% (p=0,0914) rispetto al 26,4% con il placebo
  • La variazione percentuale mediana nella frequenza delle crisi per la popolazione ITT era: 8 mg = -26,3% (p=0,0261), 12 mg = -34,5% (p=0,0158) rispetto al -21,0% con il placebo
  • Gli effetti collaterali più comuni erano capogiri, sonnolenza, cefalea, cadute, irritabilità e atassia

Informazioni sull'epilessia

L'epilessia è una delle condizioni neurologiche più comuni al mondo, che colpisce circa 8 su 1000 persone in Europa e si stima che in tutto il mondo il numero di persone affette da questa malattia raggiunga i 50 milioni.[8, 13]

L'epilessia è caratterizzata da un scarica anomala di impulsi delle cellule nervose nel cervello che causa la comparsa di crisi epilettiche. A seconda del tipo, le crisi possono essere limitate a una parte del corpo o possono essere generalizzate e coinvolgere l'intero corpo.

I pazienti possono anche provare sensazioni anomale, alterazioni del comportamento o della coscienza. L'epilessia è un disordine neurologico con molte possibili cause. Spesso la causa dell'epilessia è sconosciuta. Qualsiasi elemento di disturbo del normale schema dell' attività neuronale, dalla malattia al danno celebrale e ai tumori, può causare la comparsa di crisi epilettiche.

Informazioni su Eisai Europa nel campo dell'epilessia

Eisai si è impegnata nello sviluppare e nel fornire nuovi trattamenti efficaci per migliorare la qualità di vita dei pazienti con epilessia. Lo sviluppo di FAE rappresenta un'area strategica per Eisai in Europa, Medio Oriente, Africa e Russia (EMEA).

Nella regione EMEA Eisai dispone attualmente di tre farmaci autorizzati alla commercializzazione:

  • Zonegran® (zonisamide) come monoterapia* e terapia aggiuntiva nei pazienti adulti con crisi a esordio parziale, con o senza generalizzazione secondaria. (Zonegran è in licenza dal produttore Dainippon Sumitomo Pharma).
  • Zebinix® (eslicarbazepina acetato) come terapia aggiuntiva nel trattamento di pazienti adulti con crisi parziali, con o senza generalizzazione secondaria (Zebinix è sotto licenza di BIAL).
  • Inovelon® (rufinamide) come terapia aggiuntiva nel trattamento di crisi epilettiche associate alla sindrome di Lennox-Gastaut in pazienti di età pari o superiore a 4 anni. La monoterapia con zonisamide non è attualmente rimborsata in Italia

*la monoterapia con zonisamide non è attualmente rimborsata in Italia

Informazioni su Eisai

Eisai è una delle case farmaceutiche leader a livello mondiale nella Ricerca e Sviluppo (R&S) e ha come missione aziendale quella di "dare priorità ai pazienti e alle famiglie e aumentare i benefici per la salute" che Eisai stessa definisce come "human health care" (hhc). Eisai ha recentemente ampliato la sede commerciale, di ricerca e di produzione di Hatfield nel Regno Unito che ora supporta le attività in continua crescita dell'area EMEA.

Eisai si concentra nelle sue attività di R&S in tre aree terapeutiche chiave:

  • Neuroscienze: Alzheimer, sclerosi multipla, dolore neuropatico, epilessia, depressione
  • Oncologia: terapie antitumorali, regressione del tumore, estirpazione del tumore, anticorpi e terapie di supporto per il cancro, sollievo dal dolore e dalla nausea
  • Reazioni immunologiche/vascolari: sindrome coronarica acuta, malattia aterotrombotica, sepsi grave, artrite reumatoide, psoriasi, morbo di Crohn

Con attività negli Stati Uniti, in Asia, in Europa e nel mercato nazionale giapponese, Eisai impiega oltre 11.000 dipendenti in tutto il mondo. In Europa, Eisai è impegnata in operazioni di vendita e marketing in oltre 20 mercati, tra cui Regno Unito, Francia, Germania, Italia, Spagna, Svizzera, Svezia, Irlanda, Austria, Danimarca, Finlandia, Norvegia, Portogallo, Islanda, Repubblica Ceca, Russia Slovacchia, Paesi Bassi e Belgio.

Per ulteriori informazioni visitare il sito web http://www.eisai.com

Bibliografia

1. Eisai Data on File.

2. Rogawski MA. Epilepsy Currents 2011;11:56-63.

3. Meldrum BS, et al. Neurotherapeutics 2007;4:18-61.

4. Rogawski MA, et al. Nat Rev Neurosci 2004;5:553-564.

5. Brodie MJ. Seizure 2010; 19: 650-655.

6. Hanada T, et al. Epilepsia. 2011 Jul;52(7):1331-40. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe

http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012].

7. Krauss GM. Serratosa JM, Villanueva V et al. Neurology 2012: Available at: http://www.neurology.org/.

8. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012].

9. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7.

10. French JA. Neurology 2012;79:1-1.

11. French J, et al. 2011, IEC Rome. Abstract# 122/ Ref 020.

12. Cramer JA, et al. JAMA. 1989 Jun 9;261(22):3273-7.

13. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233.

Date of preparation: July 2012

Job code: Perampanel-UK2029

SOURCE Eisai Europe Limited

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