Hemispherx Biopharma's Ampligen(R) Tested in Combination With Experimental Vaccine From Leading Cancer Research Institute
First Test of Ampligen(R) as a Cancer Vaccine Adjuvant in a Clinical Study of Ovarian Cancer Patients
PHILADELPHIA, June 21, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") today announced that it has entered into a Material Transfer and Research Agreement with the University of Pennsylvania School of Medicine to provide Ampligen® [rintatolimod; poly(I)·poly(C12,U)], an experimental therapeutic, for testing as a vaccine adjuvant in a human clinical study in ovarian cancer.
The Principal Investigator is Dr. George Coukos who is the Celso Ramon Garcia Associate Professor of Reproductive Biology, Associate Chief of the Division of Gynecologic Oncology, and Director, Ovarian Cancer Research Center, at the University of Pennsylvania School of Medicine Abramson Cancer Center. He is a recognized global leader in ovarian cancer treatment and research. His research focus over the last several years has been on understanding the immune system's response to ovarian cancer, and on developing therapies which enhance that response.
This study is a Phase I/II randomized clinical trial for subjects with recurring ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of a vaccine comprised of autologous oxidized tumor cell lysate (OC-L) administered by intradermal /subcutaneous injection in combination with intravenous Ampligen®. The OC-L vaccine is an experimental cancer immunotherapy under development by the University. This study represents the first use of Ampligen® as a cancer vaccine adjuvant in a well-controlled clinical study.
Dr. William A. Carter, CEO and Chief Scientific Officer at Hemispherx stated, "...we are excited to have the opportunity to work with Dr. Coukos and his colleagues to combine Ampligen®, our selective Toll-like receptor 3 agonist which has potent immune modulating activity, with their creative OC-L autologous cancer vaccine. We are particularly pleased that the first patient has already been enrolled in the study and has received their initial dose of study drug."
Hemispherx views the potential use of Ampligen® as a component of cancer immunotherapy as an important development opportunity. The Company's near term focus in cancer is to initiate a series of collaborations with renowned cancer research experts at premier institutions to help define the best mode of integrating Ampligen® into immunotherapy strategies to potentially advance the treatment of cancer.
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.
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.