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HEMISPHERX BIO
5.100 (c) USD
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US42366C5094 HEB

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HEMISPHERX BIO : HEB & Département fédéral de la défense

sevy00
14 mai 201416:32

Hemispherx Biopharma collabore officiellement avec le Département fédéral de la défense , de la protection civile et des Sports pour étudier Alferon ® souches contre la grippe Tamiflu résistant Virus

... Étude doit être effectuée par l'Institut suisse pour la protection ABC ( SPIEZ Laboratoire)

Philadelphie , PA , le 14 mai 2014: Hemispherx Biopharma , Inc. ( NYSE Amex : HEB ) ( la «Société » ou « Hemispherx " ) , a annoncé qu'elle a conclu une entente de recherche en collaboration formelle pour tester Alferon N Injection ® , le seulement multi-espèces , l'interféron alpha naturel approuvé dans le commerce aux États-Unis Il va maintenant être évaluée par rapport type sauvage et le virus de la grippe Tamiflu ® (oseltamivir ) résistant H7N9 dans l'annexe DEA ( accord d'échange de données ) pour accord Bio -défense civile médicale et entre la suisse chirurgien général et le ministère américain de la Défense .

La prévalence croissante de Tamiflu ® résistant à virus Influenza A , en particulier contre H7N9 , a été largement rapporté et est due en grande partie au fait que seulement une mutation en une seule étape en ce virus génétiquement instables peut le rendre résistant au Tamiflu ® .

Cette collaboration vise à étendre les résultats annoncés lors de la réunion annuelle de la 53e Conférence Interscience sur les agents antimicrobiens et la chimiothérapie (ICAAC ) à Denver , Colorado Septembre 13-15 2013. Ces expériences ont été menées par le professeur Juergen Richt , DVM , Ph.D. . , Directeur du Département du Centre de la sécurité intérieure de l'excellence des États-Unis pour les nouvelles et zoonotique maladies animales ( CEEZAD ) et a démontré que Alferon ® N est un inhibiteur puissant des deux virus de type sauvage de la grippe H7N9 ainsi que des souches de la grippe ® résistant Tamiflu .

Selon une nouvelle étude menée par la Cochrane Collaboration à but non lucratif , le réseau mondial d'universitaires de soins de santé , le Tamiflu ® n'est pas prouvée pour réduire les complications de la grippe , comme la pneumonie et séjours à l'hôpital , soulevant des questions sur le Tamiflu ® utilisent contre les pandémies . Tel que publié dans le British Medical Journal (BMJ 2014 ; 348 : g2545/Ibid g2547 ) , l'examen des études cliniques antérieures trouvé réduction prophylactique des symptômes de seulement 55 % et aucune indication que le Tamiflu ® est efficace dans la réduction des complications , des composants clés dans la réduction de la taux de morbidité et de propagation de la pandémie de grippe . Les études mettent aussi en doute le rapport bénéfice / risque fourni par Tamiflu .

The Cochrane ont examiné les 107 rapports cliniques existantes sur le Tamiflu ® et un autre médicament moins largement utilisé contre la grippe (Relenza ® (zanamivir ) ) . Les données tirées des essais cliniques examinés ont montré Tamiflu ® et Relenza ® atténué les symptômes de la grippe chez les adultes d'environ une demi-journée plus vite que chez ceux prenant un placebo . The Cochrane et le BMJ ont également appelé les gouvernements et les décideurs de la santé dans le monde entier à revoir leurs directives sur l'utilisation de Tamiflu ® à la lumière des découvertes récentes .

Colonel Dr. Sergei Bankoul , MD , Forces armées suisses Logistique , Direction des services médicaux, chef de la médecine défense CBRN des Forces armées et conseiller principal à la Suisse Surgeon General , le major-général Andreas Stettbacher , a déclaré: " Nous avons besoin d'un efficace , pratique - à utiliser , et largement administrable préventif et thérapeutique pour pandémie de grippe pour accompagner l'engagement militaire suisse a fait un test de diagnostic rapide , le point -of-care pour H7N9 de fournir un "1:2 punch" à une menace de pandémie ou épidémie et sous notre accord avec le Département américain de la Défense . Basé sur des recherches à ce jour , Alferon ® est un médicament prometteur . "

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  • sevy00
    14 mai 201416:32

    Company/Investor Contact:
    Charles Jones
    CJones & Associates Public Relations
    888-557-6480
    cjones@cjonespr.com



    Hemispherx Biopharma Formally Collaborates with the Swiss Department of Defense, Civil Protection and Sports to Study Alferon®Against Tamiflu Resistant Influenza Virus Strains

    ... Studies to be Conducted by the Swiss Institute for NBC-Protection (SPIEZ Lab)

    Philadelphia, PA, May 14, 2014: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company" or "Hemispherx"), announced that it has entered into a formal collaborative research agreement to test Alferon N Injection®, the only multi-species, natural alpha interferon commercially approved in the U.S. It will now be evaluated against wild type and Tamiflu® (oseltamivir)-resistant H7N9 influenza virus under the DEA (Data Exchange Agreement) Annex for Medical Preparedness and Bio-Defense Agreement between the Swiss Surgeon General and the US Department of Defense.

    The increasing prevalence of Tamiflu®-resistant Influenza A Virus, particularly against H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in this genetically unstable virus can make it resistant to Tamiflu®.

    This collaboration is intended to extend the results announced at the 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado September 13-15, 2013. These experiments were conducted by Professor Juergen Richt, DVM, Ph.D., Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) and demonstrated that Alferon® N is a potent inhibitor of both wild-type influenza virus H7N9 as well as Tamiflu®-resistant influenza strains.

    According to a new study by the non-profit Cochrane Collaboration, global network of health care academics, Tamiflu® is not proven to reduce flu complications, like pneumonia and hospital stays, raising questions about Tamiflu® use against pandemics. As published in the British Medical Journal (BMJ 2014;348:g2545/Ibid g2547), examination of earlier clinical studies found prophylactic reduction in symptoms of only 55% and no indication that Tamiflu® is effective in reducing complications, key components in reducing the morbidity and rate of pandemic spread of influenza. The studies also question the risk/benefit ratio provided by Tamiflu.

    The Cochrane reviewers examined all 107 existing clinical reports on Tamiflu® and another less widely used flu drug (Relenza® (zanamivir)). Evidence from the trials reviewed showed Tamiflu® and Relenza® alleviated flu-like symptoms in adults about half a day faster than in those taking a placebo. The Cochrane reviewers and the BMJ have also called on governments and health policy decision makers throughout the world to review their guidance on the use of Tamiflu® in light of the recent findings.

    Col. Dr. Sergei Bankoul, M.D., Swiss Armed Forces Logistics, Medical Services Directorate, Head of Medical CBRN Defense of the Armed Forces and Senior Consultant to the Swiss Surgeon General, Major General Andreas Stettbacher, said "We need an effective, convenient-to-use, and widely administrable preventative and therapeutic for pandemic influenza outbreak to accompany the commitment the Swiss Military has made to a rapid, point-of-care diagnostic test for H7N9 to provide a "1:2 punch" to a pandemic threat or outbreak and under our Agreement with the US Department of Defense. Based on research to date, Alferon® is a promising drug candidate."

    About Alferon® N

    Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus ("HPV") in patients 18 years of age or older.

    About SPIEZ LABORATORY

    SPIEZ is the Swiss Federal Institute for NBC (Nuclear, Biological, Chemical) Protection and is the leading organization in Switzerland charged with the safety and security of the general population against biological, chemical and nuclear threats. SPIEZ Lab has fully equipped and staffed laboratories (about 100 people) for both in-vitro and in-vivo (small rodents) testing of products to prevent or treat potential NBC types of threats. Biological testing facilities and staff include BSL (Biological Safety Lab) level 3 and 4. SPIEZ LABORATORY develops and safeguards the necessary basic scientific and technological knowledge for comprehensive NBC protection. It also provides national and international organisations, the Swiss authorities, and general population with services to prevent, to prepare for and to manage disasters and emergencies. The work under the agreement will be guided by the head of virology, Dr. Marc Strasser.

    About Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Kansas State University

    CEEZAD, Center of Excellence for Emerging and Zoonotic Animal Diseases, was officially inaugurated in June 2010, with its first annual conference, held in Manhattan, Kansas, home of Kansas State University. CEEZAD was formed to enhance the capability of the US Department of Homeland Security (DHS) by developing "state of the art" countermeasures for high priority emerging and zoonotic animal diseases. Professor Richt is The Regents Distinguished Professor of Veterinary Medicine at Kansas State University, and an Eminent Scholar of the Kansas Bioscience Association (KBA).

    About Hemispherx Biopharma

    Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (approved for refractory HPV infections) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The Company's Alferon® N approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net. Alferon® is considered an experimental product for the potential treatment of seasonal and pandemic influenza, and as such, may never be commercialized for these particular therapeutic uses.

    Disclosure Notice

    Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts and/or any other activities could vary materially from Hemispherx's expectations.

    Forward-Looking Statements

    The foregoing release contains forward-looking statements that can be identified by words such as "will be, investigative, interim" or similar terms, or by express or implied discussions regarding potential efficacy for Hemispherx's Ampligen®, or regarding potential future revenues from Ampligen®. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of Management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ampligen® will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding Ampligen® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K on file with the U.S. Securities and Exchange Commission. Hemispherx is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.



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