Healthcare Industry News: influenza vaccine
News Release - April 25, 2006
Hemispherx Biopharma Announces Retention of New Senior Personnel and Contractors Ahead of Key NDA Filing for Chronic Fatigue Syndrome TreatmentNew Management and R&D Team to Build on Critical Research on CFS Just Unveiled by Centers for Disease Control
PHILADELPHIA--(HSMN NewsFeed)--April 25, 2006--Hemispherx Biopharma, Inc. (AMEX: HEB ) today announced that it has retained a team of scientists and executives with unique experience in immunology, pharma manufacturing, and regulatory compliance to help the Company prepare for the filing of a new drug application (NDA) for the experimental immunostimulant Ampligen®, developed for the potential treatment of Chronic Fatigue Syndrome (CFS). The management and R&D expansion comes just as the federal Centers for Disease Control and Prevention has unveiled critical research that strengthens the belief that cases of CFS share common factors of hormonal and immune system dysregulation.
The CDC's findings are built around sponsored research with 20 scientists on new genetic and environmental insights into CFS. According to Julie L. Gerberding, director of the Centers for Disease Control and Prevention, which sponsored the huge project, "This is a very important step forward in the field of chronic fatigue syndrome research." CFS is believed to affect nearly 1 million Americans. Genetic-based predispositions were identified that help lift the veils of medical uncertainty regarding what has often been considered a mysterious ailment.
Hemispherx has been on the front lines of CFS research for the past decade and has been systematically acquiring the resources and skills needed to achieve the status of the first formally recognized interventive therapy. At present, no approved and recognized therapy exists for CFS.
In a letter to shareholders and a corresponding conference call, Dr. William A. Carter, Chairman and CEO of Hemispherx Biopharma, outlined the delivery of a series of specific milestones that hold particular significance for the Company as it builds on its achievements.
- The filing of a new drug application (NDA) for the Company's experimental immunostimulant, Ampligen®, developed for the potential treatment of Chronic Fatigue Syndrome (CFS), by the end of the year.
- Opportunities to file influenza-related NDAs for Ampligen®, as a co-administered immunotherapeutic with influenza vaccines.
- Ongoing discussions with key government officials on opportunities of particular interest for the company including CFS.
To assist Hemispherx in its regulatory initiatives, as well as the Company's pursuits in influenza /vaccine-additive opportunities, Hemispherx has also retained the services of Dr. Alastair George Ramsay as Senior Vice President. Since 1989, Dr. Ramsay has been EVP, Technical and Regulatory Affairs, at Albamed, Inc, which he also co-founded. Albamed provides consulting support and hands-on guidance in the Regulatory, Chemistry/Manufacturing, Process and Product Validation and GMP areas. Dr. Ramsay also brings considerable experience in developing and manufacturing vaccines: He was recently a designated "expert" member of an FDA- and Federal Court- approved team at a major manufacturer of flu vaccine.
Hemispherx has also brought aboard Wayne R. Godfrey, M.D. in the key role of Associate Medical Director. Dr. Godfrey will initially be focusing on pre-clinical and clinical studies for development of the immunostimulant Ampligen. Dr. Godfrey has spent his career on the cutting edge of immunology. He was most recently Director of Cellular Immunology at a biotechnology company researching new immunotherapy strategies. Earlier, he was Assistant Professor, University of Minnesota, Departments of Medicine and Pediatrics and at the Division of Hematology, Oncology and Transplantation, as Hematology/Bone Marrow Transplantation Fellow, Stanford University Hospital, Palo Alto. Dr. Godfrey's practical expertise in immunology brings high value.
To ensure that it also has the expertise needed in statistics and data formulation, Hemispherx has partnered with two renowned consulting firms. Octagon Research Solutions, a leader in the electronic transformation of clinical research and development for NDAs, has been brought in to streamline the regulatory filing process, and SM&A is offering its expertise to improve the process of responding to various federal procurement opportunities for the experimental immunotherapeutic Ampligen® and the approved natural interferon product, Alferon N .
"Building the right team for this challenging arena takes patience and dedication, and it's a task we take very seriously," Dr. Carter emphasized. "With the unique skill sets and competencies offered by each of these individuals and organizations, I'm confident that we have the infrastructure and knowledge base in place to not only deliver on the promise of our scientific breakthrough but further build on our market momentum."
About Hemispherx Biopharma
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx Biopharma's flagship products include Alferon® and the experimental immunotherapeutics/antivirals Ampligen® and Oragens(TM). Alferon® is approved for a category of STD infection, and Ampligen® and Oragens(TM) represent experimental nucleic acids being developed for globally important viral diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon® N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
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, change 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. Any specifically referenced investigational drugs and associated technologies of the company (including Ampligen®, Alferon® LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Source: Hemispherx Biopharma
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