|April 11, 2005
|Hemispherx Biopharma's Investigational Drug Increases Physical Performance in New Chronic Fatigue Syndrome (CFS) Clinical Study
|Maximum oxygen consumption increased 10-fold with Ampligen® vs. Placebo
Barcelona, Spain, Monday, April 11, 2005: At the 18th International Conference on Antiviral Research, Hemispherx (AMEX: HEB) presented new peer-reviewed data entitled “Correlation of Increased Oxygen Consumption with Enhanced Treadmill Performance in Patients with Chronic Fatigue Syndrome (CFS) as a Function of Ampligen®”.
According to recent reports by the Centers for Disease Control and Prevention (CDC), CFS, a disease that affects between 400,000 and 800,000 Americans, is more serious than multiple sclerosis with respect to medical severity and overall economic impact on society. This was reported in the CFS Advisory Committee Report dated January 5, 2005.
Specifically, CFS imparts a clinically significant, profound deficit in oxygen utilization to patients, which impairs their ability to perform a range of ambulatory functions necessary to maintain quality of life. Similar oxygen consumption deficits have been observed in other chronic diseases such as congestive heart failure/angina (“CHF”) and chronic pulmonary conditions such as arterial hypertension (“AH”) both of which now have a range of readily available, commercially approved therapeutics for disease intervention.
The experimental Ampligen® treatment in CFS improved exercise duration up to two times more than approved (or approvable) drugs for their respective chronic disease indications. Ampligen® increased the percentage improvement in endurance (as determined by an “intent to treat” analysis) more than 15% over the placebo group. In the CFS study, maximal oxygen consumption (VO2max) increased ten fold with Ampligen vs. Placebo. There was a high correlation between improvement in exercise duration and increase in VO2 max (p<0.00001). VO2max is a measure of oxygen consumption at maximum exertion.
By comparison, analysis of seven (7) recent clinical studies, which resulted in commercial approvals (or “approvable” letters) for various drugs used in these other allied disease categories (both CHF and AH), showed much lower magnitudes of physical performance improvements due to therapeutic interventions. For example, in CHF: Fosinopril (6.7% improvement), Captopril (6.2%), Ranolazine (6.5%) and Ranolazine (5.7%); in AI, Tracleer (10.6% improvement), Remodulin (8.0%), Remodulin (4.1%) and Remodulin (6.1%). All therapeutic measurements in these seven (7) other studies were determined by exercise treadmill testing (or extent of walking), similar or identical to the therapeutic endpoint used in the CFS study.
With respect to Ampligen® in the CFS pivotal study, no significant differences were observed between the two groups (drug vs. placebo) for treatment dropouts, the incidence of serious adverse events, or missed treatment doses. With respect to relative safety of the experimental therapeutic, there were also no significant differences in week forty blood chemistry, hematology, or thyroid function parameters.
These results are consistent with two prior open label trials and a phase II, double-blind, placebo controlled, multi-center clinical trial of Ampligen®.
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities. Its flagship products include Alferon N® and the experimental antiviral products, Ampligen® and Oragens(TM). These novel Alferon-N proteins, commercially available for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Its four major technology platforms include large-and small-agent components for potential treatment of various chronic viral infections, and are being developed with various corporate, governmental and academic collaborators worldwide. Hemispherx has more than 200 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N®) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: www.hemispherx.net
Investor Relations Group
Erik Lux/ Adam Holdsworth/John Nesbett
Investor Relations Group
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 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. Only Clinical Studies under well-controlled conditions can establish efficacy and safety of any product including Ampligen®, and this determination can only be legally made by regulatory bodies. Clinical trials for other potential indications of the approved biologic Alferon N do not imply that the product will ever be specifically approved commercially for these other treatment indications including avian flu.