October 21, 2008
Hemispherx Biopharma to Present At 48th Annual ICAAC Conference; Presentation Highlights Pending NDA Data for Treating CFS
PHILADELPHIA, Oct. 21, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that its Medical Director, Dr. David Strayer, will present clinical data at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C. on October 27, 2008. ICAAC is one of the largest medical/scientific conferences held annually in U.S. The presentation, entitled "Review of the Integrative Studies Supporting an NDA for Ampligen(r) in the Treatment of Seriously Debilitating Chronic Fatigue Syndrome (CFS)," will focus on results of 13 clinical studies with Ampligen(r), an experimental biotherapeutic, with respect to improvements in exercise capacity, CFS signs and symptoms, medication use and drug safety profile following more than 90,000 Ampligen(r) injections.
In the USA, no drugs are currently approved for treating CFS, which affects more than 4 million patients and imposes a multibillion dollar economic burden on American society. Accordingly, the Centers for Disease Control (CDC) is conducting a nationwide Awareness Campaign. Also, new gene analysis studies in CFS are now revealing a more rapid and reliable diagnostic path to identify this debilitating disorder, which is presently diagnosed solely by clinical criteria.
Hemispherx Biopharma, Inc. is a specialty pharma 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) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(r) and Oragens(r). Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids being developed for globally important debilitating 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 90 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial 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; Similarly, the completion of NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.
This news release was distributed by GlobeNewswire, www.globenewswire.com
CONTACT: Hemispherx Biopharma, Inc. Company/Investor Contact: Dianne Will 518-398-6222 [email protected] CCG Investor Relations Sean Collins, Sr. Partner 310-477-9800