|May 05, 2003
|HEMISPHERX BIOPHARMA ENTERS INTO THERAPEUTIC AGREEMENT FOR AMPLIGEN® WITH THE CENTER FOR CELL AND GENE THERAPY AT BAYLOR COLLEGE OF MEDICINE
|Immune stimulation through dendritic cells holds promise for increasing cancer remission rates.
Philadelphia, PA, Monday, May 05, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it has entered into a Research Project Agreement with the prestigious Center for Cell and Gene Therapy at the Baylor College of Medicine in Houston, Texas. The Center presently receives multimillion dollar support from the National Institutes of Health for its cutting-edge research.
The Research Project consists of work conducted utilizing the experimental Phase III drug Ampligen in the implementation of the protocol entitled “Administration of neomycin resistance gene-marked LMP2a-specific CTL to patients with relapsed EBV-positive Hodgkin’s Lymphoma” with Ampligen alone being substituted for multiple other cytokines including TNF-α, IL-Iβ and IL-6 as the dendritic cell maturing agent.
What are dendritic cells.
Dendritic cells help activate the body’s cellular immune system to fight invading viruses or cancer cells by presenting the foreign molecular components (antigens) to other immune cells called T lymphocytes.
Clinical Targets of Cell and Gene Therapy at Baylor:
The diseases currently targeted by the Center for Cell and Gene Therapy are Epstein-Barr virus (EBV)- positive Hodgkin Disease, nasopharyngeal carcinoma, and various viral infections that occur during allogeneic stem cell and solid organ transplantation. The protocol for generating dendritic cells depends on dendritic cell maturation with growth factors. A final critical maturation step can be induced by a variety of immune danger signals, one of which is poly I:C. (a product similar to Ampligen but with significant toxicities and accordingly withdrawn from clinical testing). Since the more mature the dendritic cells, the better the cancer killing cells, called CTL grow, there is great interest in using Ampligen to mature dendritic cells.
Dr. William A Carter, CEO and President, stated “We are very excited with this research project and its underlying clinical potential. We believe that the Center for Cell and Gene Therapy will be able to get the protocol implemented in the clinic very quickly. If the experimental Phase 3 immunotherapeutic Ampligen would be proven effective for maturing dendritic cells, then Ampligen might be adopted by many researchers who are using dendritic cells for clinical trials in a variety of major life threatening diseases.”
As per the Agreement, Hemispherx will provide the necessary Ampligen® for the research and the Baylor College of Medicine will conduct and fund the clinical research, as well as freely publish papers thereon. Hemispherx will retain ownership of all intellectual property rights in all inventions and discoveries generated by the Research Project.
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, Ampligen and Oragens. These novel proteins and 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) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
Hemispherx Biopharma, Inc., Investor Relations
(518) 398-6222, Fax: (518) 398-6223
Robert Giordano, MRB Investor Relations
(212) 495-0200, Fax: (212) 495-0746
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 the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the company (including AmpligenÒ and Oragensä) 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. Clinical trials for other potential indications of the approved biologic AlferonÒ do not imply that the product will be specifically approved commercially for these other treatment indications.