Hemispherx's Ampligen Flu Vaccine Program To Be Presented At International Vaccine Workshop In Japan - Update
10/9/2009 3:19 AM ET
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(RTTNews) - At the "Mucosal Immunity" session of the Japan-France Vaccine and Infectious Diseases Workshop in Osaka, Japan on October 10, Hideki Hasegawa, Chief, Laboratory of Mucosal Vaccine Development Virus Research Center, Japanese National Institute of Infectious Diseases will review data on Hemispherx Biopharma Inc.'s (HEB: News ) Ampligen, an experimental immunotherapeutic.
Hemispherx's collaborative influenza vaccine development partner in Japan is Biken Corp. As part of an agreement to develop an effective influenza vaccine for Japan, in December 2007, Biken licensed Hemispherx's experimental drug Ampligen as an immune enhancer to influenza vaccines. BIKEN owns intellectual property rights related to candidate novel influenza vaccines.
In June of this year, Biken announced its plan to invest a total of 35 billion Yen (US $350 million) to expand its Flu production capacity in Kanonji City. The Japanese research teams believe that Ampligen is an essential co-ingredient to provide experimental efficacy with Biken vaccines.
A pandemic influenza vaccine has yet to be approved and distributed in Japan. The shipments of the first swine flu vaccines in the United States began arriving this week, according to reports.
Hemispherx's New Drug Application for Ampligen seeking approval in the treatment of chronic fatigue syndrome, or CFS, is still under FDA review. In February, the regulatory agency extended the review period by three months to May. Again on May 26, the FDA informed the company that it would require up to 1-2 additional weeks to decide on Ampligen. However the new deadline has also passed. According to reports, the company CEO William Carter has informed a news portal about the regulatory status of Ampligen and the report on the status of Ampligen is expected to be released Friday.
