Hemispherx Biopharma, Inc. 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 tumour 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.
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.