PHILADELPHIA, Sept. 26, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) ("Hemispherx" or the "Company") announced that it presented new data on a blood test for Chronic Fatigue Syndrome (CFS). CFS is a severe disorder consisting of profound fatigue and a variety of other debilitating symptoms that affects up to 4 million Americans. CFS places an economic burden on the Unites States estimated at more than $9 billion annually. The data presented at the IACFS/ME Biennial Conference held September 22-25, 2011 in Ottawa, Ontario, Canada is based on Chronix Biomedical, Inc.'s ("Chronix") technology, which analyzes DNA released into the bloodstream by dying and damaged cells and has the potential to detect genomic alterations unique to diseased cells. Previously, Chronix utilized Next Generation Sequencing (NGS) to generate sufficient DNA sequences to provide the statistical power to identify alterations in blood DNA from patients with breast and prostate cancer vs. normal healthy controls. The aim of this recent CFS study was to find signature DNA sequences from patients with CFS compared to healthy controls with respect to their diagnostic predictive value, as well as, to potentially provide new insight into CFS biology. DNA extracted from serum samples of CFS subjects and normal healthy controls was sequenced and compared to the human genome. A total of about 10,000 high quality sequence reads were generated from each serum sample and four genes were identified by Multivariate Regression that separated CFS patients from the normal control group with a c-value of 0.95. These results support additional studies with a larger CFS cohort using more powerful Massively Parallel Sequencing platforms with the aim of reduction to validated clinical assays for the diagnosis and evaluation of CFS and to explore whether the technology can be used to identify how different persons with CFS will respond to Hemispherx's experimental drug Ampligen®.
Chronix and Hemispherx previously announced (March 3, 2011) the filing of a joint patent application for a blood test for CFS based on this technology. Chronix and Hemispherx are currently planning to validate the ability of the approach to identify how different persons with CFS can respond to Hemispherx's experimental drug Ampligen®. The blood test for CFS is experimental in nature and has not been evaluated by any regulatory agency. It is currently limited to investigational use.
About Chronix Biomedical, Inc.
Chronix Biomedical, Inc. is pioneering a unique approach to the diagnosis, monitoring and management of a broad range of cancers, neurologic diseases and other medical conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has published its results on spongiform encephalopathies, multiple sclerosis, breast cancer, prostate cancer and multiple myeloma in several scientific journals. It is currently conducting studies in other cancers. Chronix is headquartered in San Jose, California and has research facilities in Germany. Drug developers and other organizations interested in obtaining more information can call 408-960-2306 or email Chronix at info@chronixbiomedical.com. The aforementioned blood test for Chronic Fatigue Syndrome, and other diseases, is experimental in nature and has not been evaluated by any regulatory agency. It is currently limited to investigational use.
About Hemispherx Biopharma, Inc.
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® (FDA approved for a category of sexually transmitted diseases) 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. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). 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® and Alferon® LDO) 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. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications. The scale-up of Alferon N manufacturing could be delayed by various critical steps including those involved in construction, GMP compliance, formulation, packaging and labeling, as well as potential issues related to 3rd party vendors including without limitation various "fill and finish" procedures.