Hemispherx Biopharma’s Ampligen® is being tested in combination with an experimental ovarian cancer vaccine developed by the Penn Ovarian Cancer Research Center.

Hemispherx Biopharma, Inc. (“Hemispherx”) announced yesterday that it 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 ovarian cancer clinical study.

George Coukos, M.D., Ph.D., Celso Ramon Garcia Associate Professor of Reproductive Biology; Associate Chief, Division of Gynecologic Oncology & Director, Ovarian Cancer Research Center; Abramson Cancer Center, University of Pennsylvania

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 1/2 randomized clinical trial for subjects with recurring ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility, safety, and 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 of Pennsylvania. 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.

Source:

• Hemispherx Biopharma’s Ampligen® Tested in Combination with Experimental Vaccine from Leading Cancer Research Institute, Hemispherx Biopharma, Inc., Press Release, June 21, 2011.

• A Phase I/II Randomized Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer, Clinical Trial Summary, NCT01312389, http://www.ClinicalTrials.gov.

About Ampligen®

Nucleic acid compounds represent a potential new class of pharmaceutical products that are designed to act at the molecular level for treatment of human diseases. The Hemispherx Biopharma drug technology utilizes specifically-configured RNA (Ribonucleic acid). The Hemispherx double-stranded RNA drug product, trademarked Ampligen®, an experimental, unapproved drug, which is administered intravenously, is in human clinical development for various therapeutically oriented studies, including treatment for chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME), HIV, renal cell carcinoma and malignant melanoma.

Based on the results of pre-clinical studies and clinical trials, Hemispherx believes that Ampligen®, an experimental agent, may have broad-spectrum anti-viral and anti-cancer properties. Approximately 500 patients have received Ampligen® in clinical trials authorized by the Food and Drug Administration (“FDA”) at over twenty clinical trial sites across the U.S., representing the administration of more than 40,000 doses of this drug, and Ampligen® is available only through clinical trials for limited indications.

Clinical trials already conducted by Hemispherx U.S. include treatments of CFS/ME, other infectious diseases such as Hepatitis B, HIV, and clinical trials for cancer including patients with renal cell carcinoma and malignant melanoma. Certain of these studies to date have not been well-controlled and accordingly additional tests will be necessary for support of regulatory approvals.

Hemispherx believes that Ampligen® has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely debilitating or life threatening diseases that have been treated. A mild flushing reaction has been observed in approximately 15% of patients treated in our various studies. This reaction is occasionally accompanied by erythema, a tightness of the chest, tachycardia, anxiety, shortness of breath, subjective reports of “feeling hot,” sweating and nausea. The reaction is usually infusion-rate related and can generally be controlled by slowing the infusion rate. Other adverse side effects include liver enzyme level elevations, diarrhea, itching, urticaria (swelling of the skin), bronchospasm, hypotension, photophobia, rash, bradycardia, transient visual disturbances, arrhythmias, decreased platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function tests, occasional temporary hair loss and various flu-like symptoms, including fever, chills fatigue, muscular aches, joint pains, headaches, nausea and vomiting. These flu-like side effects typically subside within several months.

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®). Hemispherx 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.