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Hemispherx Biopharma, Inc.'s (HEB) collaborative partner, Japan's National Institute of Infectious Diseases (JNIID), has published an article in the Institut Pasteur's publication Microbes and Infection 9 (2007). The article provides further support for the use of Ampligen(R), an experimental therapeutic, to strengthen the effects of avian flu vaccine and broaden the vaccine's protective effect to multiple ("heterologous") flu strains. This supports potentially extending existing supplies of avian flu vaccine by co-administering it with Ampligen(R).
According to the article, "intranasal administration of Ampligen(R) combined with H5N1 vaccine derived from a highly pathogenic influenza virus clinical isolate induced cross-protective mucosal immunity against heterologous H5N1 influenza virus infection. Intranasal vaccination co-administered with the TLR-3 agonist, Ampligen(R), appears to offer an effective strategy against an influenza pandemic, regardless of the strain of H5N1."
On October 10, 2007 Hemispherx filed a New Drug Application (NDA) for Ampligen(R) as a primary therapy for Chronic Fatigue Syndrome (CFS). The Company plans additional filings with regulators in Europe in the coming months. The use of Ampligen(R) as both a CFS treatment and as an experimental immune enhancer with vaccines derives from the broad immune system stimulant effects of TLR3 activators such as Ampligen(R). JNIID has also initiated research on the intranasal co-administration of its HIV-1 vaccine with Ampligen(R) as an immune enhancer.
Hemispherx is engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based disorders. Hemispherx's flagship product includes Alferon N Injection(R), the Company's injectable formulation of Natural Alpha Interferon which is approved by the FDA for genital warts. Alferon N is also being developed to fight other viral diseases, such as West Nile virus. Ampligen(R) and other experimental nucleic acids are being developed for the potential treatment of globally important viral diseases and disorders of the immune system including HPV, HIV, CFS, Hepatitis and influenza.
Alferon N Injection(R) currently competes with Schering's (SGP) injectable recombinant alpha interferon product, INTRON(R) A, for the treatment of genital warts. Medigene recently received FDA approval for a self-administered ointment, Veregen(TM), which is indicated for the topical treatment of external genital and perianal warts. 3M Pharmaceuticals (MMM) offers competition from its immune-response modifier, Aldara(R), a self-administered topical cream, for the treatment of external genital and perianal warts.
The Company had approximately $17,854,000 in cash and cash equivalents and short-term investments at September 30, 2007. Their accumulated deficit was $181.8 million. Loss per share for the quarter was (8c), as compared to a loss of (60c) for the same period in 2006.
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