PHILADELPHIA, Aug. 27, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today provided updates on Alferon N(tm) in connection with West Nile Virus (WNV) and on its flagship pharmaceutical, Alferon N Injection(r) in treating human papilloma virus (HPV) through its specialty pharmacy agreement with Armada Health Care.
According to the Centers for Disease Control, as reported by Reuters on August 8, the number of mosquito-borne West Nile Virus (WNV) infections in the U.S. is "up sharply" over the same time last year. At present there is currently no FDA approved therapy for the potentially life threatening infection of the brain or spinal cord. Hemispherx, which is working in collaboration with Cornell University and Weill Cornell Medical College/ New York Hospital and under the direction of Dr. James Rahal, Professor, announced that enrollment in its nationwide Alferon N(tm) Phase IIb trial to treat WNV has now reached approximately the 50% mark. Patients and physicians will find background information at www.nyhq.org/posting/rahal.html.
In lab studies, Alferon N(tm), which is a natural cocktail of 8 alpha-interferons which may show synergistic effects (up to 50-100 fold over recombinant interferons) against pathogens such as WNV, is being evaluated in double-blinded randomized multi-center tests. Laboratory studies are useful tools that do not necessarily predict any clinical benefit or outcome which can only be evaluated by well-controlled clinical trials, such as the ongoing clinical tests. To the Company's knowledge, the ongoing Alferon N(tm) West Nile Virus study is the only well-controlled clinical study being conducted in the United States at this time.
Separately, Hemispherx reported early results from its April 23, 2007 strategic agreement with Armada Health Care to launch Alferon N(tm) sales for refractory (difficult-to-treat) HPV. Dr. William A. Carter, Chairman and CEO of Hemispherx, commented, "We are pleased to see that Alferon N sales under this agreement may be gaining traction, with the Armada agreement now contributing about 40% to overall Alferon N sales, with a significant increment within the last 30 days over previous Armada-invested sales."
Hemispherx has initiated a nationwide education program for Armada's sales representatives by means of periodic live Internet broadcasts using Board-Certified physicians, followed by live question-and-answer sessions.
The Company's agreement with Armada Health Care, its first such marketing/distribution collaboration, has launched Alferon N Injection into Armada's Specialty Pharmacy infrastructure. Twenty-two million Americans, according to NIH data, are afflicted by HPV (Human Papillomavirus), for which Alferon(r) may be indicated in refractory cases.
Specialty pharmacy programs are characterized by intense therapeutic management and centrally managed distribution of medications treating chronic health conditions. Specialty Pharmacy serves unique patient populations that often utilize injectable, infusion and biotech drugs. Examples of some of the disease states treated by specialty pharmacy programs are cancer, HIV/AIDS, Crohn's disease, cystic fibrosis, diabetes, hemophilia, hepatitis, multiple sclerosis, pulmonary hypertension and renal dialysis, among others. Approximately 3% of U.S. residents take pharmaceuticals under specialty pharmacy programs, with a growth rate twice that of traditional pharmaceuticals (27% vs. 13%).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) and the experimental therapeutics Ampligen(r) and Oragens(r). Alferon N Injection(r) is approved for a category of STD infection, and Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids being developed for globally important viral diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N Injection(r)) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(r), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications.