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FDA's Decision on Ampligen in the Near Future

 
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Mixin



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PostPosted: Tue Jun 02, 2009 6:05 pm    Post subject: FDA's Decision on Ampligen in the Near Future Reply with quote

A few recent reports; studies also posted:

Hemispherx Biopharma Announces Possible Brief Delay in FDA Action On Ampligen(r) New Drug Application

PHILADELPHIA, May 26, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) today announced that the U.S. Food and Drug administration ("FDA") has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen(r) (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome. Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company's development plan for Ampligen(r) continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.
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Hemispherx Biopharma Presents Influenza Prevention / Treatment Platform at International Conference in Rome under Auspices of Italian Government
Company Accelerates Collaborations with Governmental, Academic and Pharmaceutical Groups to Prevent Pandemic Influenza
PHILADELPHIA, June 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced today an invitation, funded entirely by the government of Italy, to present its technology platform for influenza control, at the upcoming "International Conference on Biotechnologies and Finance" in Rome on July 4-5, 2009, at the Sheraton
Parco de Medici. According to the Conference Organizers, leaders of "private and public research centers, intellectual property holders and financial experts from Europe, Australia, Canada, Estonia, Singapore and the USA" will participate. Hemispherx will present in a Round Table Discussion on Pandemic Influenza, moderated by Dr. Elemer Piros, Senior Pharmaceutical Analyst at Rodman and Renshaw, a USA investment bank.

Hemispherx has a broad-based technology platform for confronting the potential of an influenza pandemic, which consists of both preventative (vaccine) components as well as experimental therapeutic interventions. Clinical results from trials conducted in Australia are being evaluated and major vaccine initiatives in Japan are being accelerated in collaboration with the Japanese National Institutes of Health and the Japanese Ministry of Health.
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PostPosted: Tue Jun 02, 2009 6:09 pm    Post subject: Reply with quote

Japan's Council Awards Innovative Technology Grants for Pandemic Influenza Vaccines Adjuvanted by Hemispherx's Ampligen(r)
Super Special Consortia' to Promote Key Technologies

PHILADELPHIA, May 21, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced that it has learned that Japan's Council for Science & Technology Policy (CSTP) awarded to the National Institute of Biomedical Innovation (NIBIO) funds to advance research with influenza vaccines utilizing a new experimental adjuvant, Ampligen(r) (Poly I: Poly C12U).

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.
(press release)
http://www.globenewswire.com/newsroom/news.html?d=165865
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PostPosted: Tue Jun 02, 2009 6:24 pm    Post subject: Reply with quote

Ampligen (R) Enhances the Effectiveness of Tamiflu Against Avian Influenza; Second Independent Preclinical Study Confirms dsRNA Increases Flu Vaccine Effectiveness

Sep.6, 2005


Hemispherx Biopharma, Inc. (AMEX: HEB) today reported two new preclinical studies on double-stranded RNA (dsRNA), including Ampligen(R), one of its flagship experimental immunomodulators. Both preclinical studies suggest a new, and potentially pivotal, role of dsRNA therapeutics in improving the efficacy of the present standards of care in both influenza prevention and treatment of acute disease.

The first preclinical report, conducted by research affiliates of the National Institutes of Health at Utah State University, compared the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen(R) (dsRNA, Hemispherx), alone and in combination against the avian flu virus (H5N1). Cell destruction was measured in vitro using different drug combinations.

Both drugs, given alone, were effective in inhibiting cell destruction by avian influenza, but viral "suppression with the combination was greater than either drug alone". The researchers reported, in summary; "The overall assessment is that there was improvement in cell protection when Ampligen(R) was combined with oseltamivir carboxylate" (Tamiflu). Further immediate experimental tests are planned.

At present, a narrow window of opportunity (approximately 48 hours) exists for effective utilization of Tamiflu after exposure to influenza. By providing a new mechanism of inhibition of avian flu, (i.e. immunologic/host defensive immune cascades), Ampligen(R), an experimental immunotherapeutic, may afford a new approach to help combat influenza virus.

Double-stranded RNA (dsRNA), such as Ampligen(R), are also specific inducers of broad-spectrum antiviral/immune response. Recently, Japanese researchers (Journal of Virology page 2910, 2005) have also found that dsRNA's increase the effectiveness of influenza vaccine by more than 300% and may also convey "cross-protection ability against variant viruses" (mutated strains of influenza virus). Ampligen(R) recently completed Phase III testing in the chronic disease, Chronic Fatigue Syndrome (CFS).

Hemispherx Biopharma recently disclosed in a letter to shareholders (September 1, 2005) that it has increased the capacity of its facility in New Brunswick, NJ to manufacture Ampligen(R) , as well as advancements in the application of Alferon LDO for potential treatment of avian flu.
http://www.redorbit.com/news/health/231310/ampligen_r_enhances_the_effectiveness_of_tamiflu_against_avian_influenza/
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