Hemispherx Biopharma Finishes Phase 3 CFS Clinical Trial; Completion of Placebo-Controlled Phase 3 Stage Represents Important Clinical Milestone
PHILADELPHIA–(BUSINESS WIRE)–Jan. 30, 2004–Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it completes this week the randomization and placebo-controlled dosage stage of its Phase 3 clinical trial for Chronic Fatigue Syndrome (CFS), becoming the first pharmaceutical company to complete a pivotal trial in this disease category, which affects more than 500,000 Americans. The Company expects to present clinical data from this study in the second quarter of this year.
The clinical trial is a multi-center, double-blind, randomized, placebo-controlled Phase 3 pivotal study of the efficacy and safety of the experimental agent Ampligen(R) versus placebo in patients with severely debilitating Chronic Fatigue Syndrome (CFS).
The Company believes that efficacy will be established by showing medically and statistically significant improvement of the primary endpoint which is improved physical performance as measured by Treadmill Exercise Tolerance Testing (ETT): Duration. Efficacy may be established by showing a medically significant increase (greater than or equal to 6.5%) in mean exercise duration (baseline compared to week 40) that is statistically significant (p less than or equal to 0,05) using analysis of covariance of log10 transformed data with Baseline ETT duration as covariate. The Company will also analyze the median absolute changes in ETT duration between termination and baseline using the Mann Whitney test. The secondary endpoints of the study are various other indices of physical performance and cognitive activity.
About Chronic Fatigue Syndrome
CFS is defined by various governmental agencies as a serious debilitating disease in which patients suffer complex symptoms, including profoundly disabling fatigue, flu-like symptoms, headaches, sore throat, joint and muscle pain, mental fogginess, depression and sleep disorders. The U.S. Center for Disease Control and Prevention has added CFS to its top priority list of emerging infectious diseases. CFS is estimated to affect over 500,000 people in the U.S., and an equal number in Europe. At present, there is no other specific treatment available for CFS and no alternative drug appear to be under development in recognized clinical trials.
Ampligen(R) is an experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, Ampligen(R) is believed to stimulate the immune system as well as inhibit the virus directly. The experimental product is currently in a Phase 3 clinical trial for the potential treatment of CFS and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS. Treatment IND status for Ampligen(R) and CFS has already been recognized by various regulatory bodies.
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Its flagship products include Alferon N(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). These novel proteins, approved for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 400 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N(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) and Oragens(TM)) 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. Clinical trials for other potential indications of the approved biologic Alferon(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS. The Alferon(R) asset for overseas sales for a category of STD is currently being acquired by the Company as part of a multi-step purchase contract of inventory, intellectual property, commercial licenses and GMP approved facilities, which house the biological operations.
Source: Business Wire (this is a press release).