Hemispherx Biopharma announced that investigators from the Tumour Vaccine Group (TVG) 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 Poly(I) • Poly(C12U) (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 Centre. The sponsors are Fred Hutchinson Cancer Research Centre/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 tumour growth by 60 per cent. Ampligen [rintatolimod; poly(I)•poly(C12,U)], an experimental therapeutic, has previously been shown to be a potent and selective agonist of Toll-like receptor 3 (TLR3).
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 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumour cells that express HER-2/neu. The University of Washington TVG 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.
The Fred Hutchinson/University of Washington Cancer Consortium is a research collaboration comprising Fred Hutchinson Cancer Research Centre, a National Cancer Institute-designated comprehensive cancer centre since 1976, and its strong collaborators, the University of Washington, Seattle Children's, and the Seattle Cancer Care Alliance. Hutchinson Centre's designation by the National Cancer Institute as a comprehensive cancer centre was expanded to include the Consortium in 2003. The Consortium brings together over 400 faculties with research interests in basic, clinical, and public health sciences related to 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.