PHILADELPHIA, March 24, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) participated in the 11th Biennial International Research and Clinical Conference held in San Francisco, California, USA, on March 20-23, 2014. The title of the presentation was "Differential Exercise Responses to Rintatolimod [Ampligen®] Exhibited by Patients with Severe Chronic Fatigue Syndrome (CFS)". This Phase III prospective, double-blind, randomized, placebo-controlled trial was conducted at twelve centers by leading researchers in fatigue and post-exertional fatigue.
The data on the experimental immunotherapeutic included a re-examination post-hoc of the primary and secondary endpoints as a function of dichotomization of patient responses.
Dichotomization of improvement in exercise performance from baseline at the ≥25% and ≥50% levels were analyzed on the Intent-to-Treat (ITT) Population. For the ITT population a significantly greater percentage of rintatolimod patients (39%) vs. placebo patients (23%) improved ET (exercise tolerance) duration by ≥25% (p=0.013) while 26% compared to 14% of rintatolimod vs. placebo patients, respectively, improved ET duration by ≥50% (p=0.028). A frequency distribution analysis of ≥25% improvement, <25% change and ≥25% worsening in ET from baseline at 40 weeks for the baseline >9 minutes cohort showed net improvement to be 18.3% for the rintatolimod cohort vs. 4.6% deterioration for placebo (p=0.015). A continuous responder analysis using 5% increments from ≥25% to ≥50% provided a robust clinical enhancement in ET effect in the rintatolimod cohort for the ITT population, as well as, for a subset of patients with baseline ET duration >9 minutes as compared to placebo. The Karnofsky Performance Score (KPS) and Vitality (SF-36 subscale) quality of life secondary endpoints demonstrated similar clinically significant improvements for the rintatolimod cohort as a function of the same ET dichotomization. Rintatolimod was generally well-tolerated in this CFS/ME population.
Rintatolimod (Ampligen®), an experimental immunotherapeutic, produced significant enhancement in ET and quality of life indicators in a subset of patients with CFS/ME. Rintatolimod also reduced deterioration in ET compared to placebo in patients who fail to improve physically.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The Company's Alferon N approval in Argentina includes the use of Alferon N Injection (under the brand name "Naturaferon") for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. 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.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, below, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. The clinical study referenced herein has been previously reviewed by the FDA and is not, in and of itself, a sufficient basis for approval. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.
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, changes 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. The final results of these efforts and/or any other activities could vary materially from Hemispherx's expectations.
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