Japan's Council Awards Innovative Technology Grants to Hemispherx's Ampligen

NIBIO's research entitled "Innovation Project for Anti-infectious vaccines in Next Generation" is aimed at the development of high-value-added vaccines for various infections such as pandemic influenza, malaria and AIDS. With regards to influenza vaccines in particular, NIBIO has worked jointly with researchers at the National Institute of Infectious Diseases (NIID), with whom Hemispherx has been collaborating in various studies. NIBIO / NIID common goal is to develop the pandemic influenza vaccine formulated with an adjuvant, Ampligen(r), an experimental therapeutic, to be administered by intranasal routes. They expect the intranasal vaccine may exert broad cross protection against the mutated viruses of pandemic influenza based on results to date.

Study of this unique vaccine preparation combined with Ampligen(r) (Poly I: Poly C12U), an experimental therapeutic, started in April 2007 under a research grant by Japan's Ministry of Health, Labor and Welfare (MHLW). The efforts in the last 2 years are now culminating in encouraging results in rodents and monkeys wherein a dramatic increase of IgA secretion was found which leads to a broadly cross-protective effect against various pandemic influenza strains.

Hemispherx indicated that a "universal vaccine", to protect potentially against shifted wild-type strains, like the swine flu strain, would need to recognize conserved sequences among different strains of influenza vaccines. "Universal vaccines" might be effectively used against shifted strains such as the current swine flu strain which is a shifted strain of HINI virus included in the trivalent seasonal vaccine. Cross-protection, such as reported in the JIID vaccine tests to date when Ampligen(r) (an experimental therapeutic) is added, is prima-facie evidence that conserved sequences may indeed be recognized with certain specific immunizing "cocktails". A further description of adjuvant technologies and regulatory considerations is discussed in the week of May 4th issue of Biocentury.

The number of swine flu confirmed cases in Japan has soared from four to 200 within days, forcing authorities to shut down schools. According to Japanese sources, the sudden rise in cases may prompt the World Health Organization to raise the pandemic alert level to the highest level of 6.

Meanwhile, Hemispherx Biopharma continues to wait for an FDA decision, due 5/25/09, on Ampligen for use as a treatment against Chronic Fatigue Syndrome.

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