AVAX Technologies, Inc. has received FDA approval to begin enrollment into a Phase I-II clinical trial of OVax for patients with advanced, chemotherapy-refractive ovarian cancer.
The study will be performed in collaboration with Cancer Treatment Centers of America, Inc. It will be centered in the CTCA hospital in Zion, Illinois, although patients also will be referred from other CTCA hospitals in Tulsa and Philadelphia, and its out-patient clinic in Seattle.
Up to 42 eligible patients with stage III or IV ovarian carcinoma will be enrolled. These patients’ cancers will have progressed despite initial surgery and chemotherapy and failed to respond to one or two salvage chemotherapy regimens. They will undergo debulking surgery, and tumor tissue will be sent to AVAX for production of vaccine. Post-operatively, they will receive intraperitoneal chemotherapy with a taxane and then will be enrolled into the protocol.
Three doses of OVax will be tested, and each of the three doses will be analyzed for immunological efficacy with the goal of optimizing the dose for treatment of patients in future trials.
As part of the business collaboration CTCA has made an up-front payment of $250,000 and will begin to make monthly payments of $25,000 upon the initiation of production of vaccines at AVAX’s Philadelphia manufacturing facility.