Will Hemispherx BioPharma's "Multiple Shots On Goal" Pay Out? Print
By Peter DePalma   
Thursday, 04 June 2009 03:08

As investors continue to wait for the FDA decision on Hemispherx BioPharma's Ampligen as a treatment for Chronic Fatigue Syndrome, the share price has continued to rise and put the company on the map as one of the most active stocks in the healthcare sector the past few days. One reason for the enthusiasm by the investment community may be the fact that the drug itself has developed into what their CEO calls a "multiple shot on goal" opportunity.

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Ampligen has multiple applications and sales opportunities for the medication and as reported last week, the management team at Hemispherx has taken a special interest in the drug's use in the fight against Influenza A virus. Another tremendous platform in the influenza space is Hemispherx’s flagship product, Alferon which is already approved by the FDA.

The following is an article excerpt by Michael Vlaicu, an analyst whose StocksHaven blog has led coverage of company news-- including a recent article about potential price per share targets as well as conference calls with HEB's CEO Dr. William Carter in which he directly responded directly to concerns raised by TheStreet.Com's Adam Feuerstein. :

Overview of H5N1

The “Influenza A (H5N1) virus” – is an influenza A virus subtype that occurs mainly in birds, is highly contagious among birds, and can be deadly to them. H5N1 virus does not usually infect people, however recently the infections with these viruses have began to occur in humans.

Of the few avian influenza viruses that have crossed the species barrier to infect humans, the H5N1 virus has caused the greatest number of detected cases of severe disease and death in humans. Each day there seems to be an increasing number of infections in humans, the most prominent reports coming in from South-East Asia. This viral infection has an extremely high mortaility rate (>60%), with a lot of concern that this avian virus could cause a pandemic of new influenza in humans, once it acquires the ability for human to human transmission. To prevent such highly contageious infectious disease as influenza, it is essential to prepare effective vaccines.

A brief history of H5N1

The first outbreak of the highly pathogenic avian influenza virus H5N1 was reported in humans and birds in Hong Kong in 1997, during which 6 out of 18 infected people died. Subsequently, re-emergence of the H5N1 virus associated with a high fatality rate (greater than 60%) has been reported in southern China, Vietnam, Thailand, Cambodia, Indonesia, Turkey, and Iraq. From January 2003 to September 2008, 387 laboratory-confirmed human cases of H5N1 were reported to the World Health Organization (WHO).

World Map of H5N1 Infected Areas:

 

 

 

 

 

 

 

 

Innate immunity and adjuvant effect

Innate immunity is a set of nonspecific mechanisms that constitute the body’s naturally occurring immune response to infection by microbes at any site. In influenza virus infection, the upper respiratory mucosal surface is the effector site of the innate immune system. The innate immune system senses viral infection by recognizing a variety of viral components, including double stranded (ds) RNA, and triggering antiviral responses.

The recognition of viral infection by the innate immune system bridges the transition between innate and

adaptive immune responses. We can take advantage of the mucosal innate immune response to enhance vaccine efficacy, which is here Hemispherx’s Ampligen comes into play.

Ampligen and

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mucosal vaccine

Seasonal influenza vaccines are prepared based on the preiction of the expected strain of aepidemic of the next season. The intranasal inoculation with both the trivalent inactivated influenza vaccine and

Ampligen(r) induced cross-protection mucosal immunity to heterologous H5N1 influenza virus in mice. Intranasal inoculation with both the annual influenza vaccine and Ampligen(r) may thus represent a strategy that, in humans, can generate protective mucosal immunity against newly emerging and highly pathogenic avian influenza viruses. Ampligen is a proven and effective drug: To date, >75,000 doses of Ampligen have been administered to humans, at an average dose of 400 mg, and it has been generally well tolerated.

To evaluate the adjuvant effect of Ampligen, the protective effect of intranasal administration of vaccine and Ampligen adjuvant against homologous and teterologous H5N1 influenza virus challenge was examined. The study clearly proved that the vaccine and Ampligen adjuvant was the most effective versus all other treatment options. What is most intriguing to notice is that Ampligen may be used as an adjuvant for any other future influenza outbreak, not just Swine and Avian strains.

Growing international interest in Ampligen

Hemispherx Biopharma Presents Influenza Prevention / Treatment Platform at International Conference in Rome under Auspices of Italian Government

Hemispherx Biopharma has announced that it has received 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 June 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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