Breast Cancer Study With Hemispherx Biopharma's Ampligen Commences

Hemispherx Biopharma HEB announced that investigators from the Tumor Vaccine Group at the University of Washington in Seattle, WA, have enrolled their first patient in their 88 patient "Phase I-II Study of HER2 Vaccination With PolyI - PolyC12U (Ampligen) as an Adjuvant in Optimally Treated Breast Cancer Patients." The TVG at the University of Washington is a multidisciplinary group of investigators focused on the diagnosis, prevention, and treatment of cancer with novel, immune-based therapies including cancer vaccines. TVG is directed by Dr. Mary L. Disis who is Professor of Medicine, Associate Dean for Translational Science in the UW School of Medicine and a Member of the Fred Hutchinson Cancer Research Center. The sponsors are Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium. The Principal Investigator is Dr. Lupe Salazar. The clinical study is the clinical follow up to the preclinical evaluation of Ampligen in combination with the University of Washington cancer vaccine in a transgenic mouse breast cancer model presented in April at the American Association of Cancer Research Conference. The combination resulted in local IL-12 production and augmented the anticancer effect of the vaccine alone inhibiting tumor growth by 60%. Ampligen [rintatolimod; poly(I)-poly], an experimental therapeutic, has previously been shown to be a potent and selective agonist of Toll-like receptor 3. The goal of this study is to see how well the combination works in treating patients with stage II-IV human epidermal growth factor receptor 2 -positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. The University of Washington Tumor Vaccine Group has developed vaccines against several cancer proteins, and in this study they are researching a new approach to make the immune response to the vaccine even better. Compounds that specifically stimulate TLR receptors are promising immune stimulators, and Ampligen has been especially promising for providing a profile of immune stimulation expected to be clinically beneficial. Dr. William A. Carter, Chairman and CEO, stated, "We are very pleased that this study is underway and we are excited at the potential of Ampligen to find a major new application in conjunction with this breast cancer immunotherapy, as well as with other specific cancer immunotherapies in development at University of Washington and other institutions." Hemispherx views the potential use of Ampligen, an experimental therapeutic, 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 for the treatment of cancer.