Philadelphia, PA, Thursday, March 03, 2011: San Jose, CA, March 3, 2011 – Chronix Biomedical ("Chronix") announced today that it filed a provisional United States patent application jointly with Hemispherx Biopharma, Inc. (NYSE Amex:HEB) ("Hemispherx") on a blood test for Chronic Fatigue Syndrome (“CFS”). Patients with CFS exhibit a wide range of disabling symptoms including the inability to overcome fatigue by rest, swollen lymph nodes and cognitive deficiencies. CFS is estimated to affect approximately 4 million Americans, according to the Centers for Disease Control and Prevention (CDC). The disorder has a negative economic impact in the United States estimated at more than $9 billion annually.
The Chronix experimental approach analyzes fragments of DNA often released into the bloodstream during the process of apoptosis or programmed cell death. Chronix is using its proprietary technology and advanced DNA sequencing platforms to measure alterations in specific regions of the chromosome, which can be detected as distinctive “signatures” in cell-free blood-borne DNA. By focusing on these signatures, Chronix’s technology can detect the presence of disease-damaged cells in simple blood samples without needing to biopsy diseased cells or tissues.
“Our technology—based on DNA released into the bloodstream by dying and damaged cells—taps into the dynamic information provided by the genomic alterations unique to each diseased cell. We capture what is happening to the DNA very early in and throughout the disease process, in real time, and patient by patient. That’s how our approach differs from other tests that focus on static genomic data or protein biomarkers,” said Dr. Urnovitz. The patient-unique signatures captured by the Chronix technology may prove useful as a companion diagnostic – a test that is used to help guide treatment decisions – and to provide information about the disease process to help pharmaceutical companies select the most efficacious drug candidates.
Use of the Chronix diagnostic technology in CFS will be evaluated in a study being planned by Chronix and Hemispherx, a leader in CFS pharmaceutical research. Dr. William Carter, Hemispherx CEO, commented, “It is with great enthusiasm that we will be conducting studies aimed at validating the utility of the Chronix technology to identify how different individuals can respond to Hemispherx’s experimental drug Ampligen®.”
The Chronix Biomedical blood test for Chronic Fatigue Syndrome is experimental in nature and has not been evaluated by any regulatory agency. It is currently limited to investigational use.
About Chronix Biomedical
Chronix Biomedical 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 firstname.lastname@example.org. The Chronix Biomedical 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
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.
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: 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 Hemispherx’s filings with the Securities and Exchange Commission. Any referenced investigational drugs and associated technologies of Hemispherx or Chronix 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 for investigational use. The forward-looking statements represent Hemispherx’s and Chronix’s respective judgments as of the date of this release. Both Companies disclaim, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of investigations do not imply that any study product or test will ever be approved or permitted for commercial distribution for the studied or other treatment uses.