Dr. Michael Har-Noy is the founder and CEO of Immunovative Therapies, Ltd., a small and very innovative biotechnology firm in Israel. Dr. Michael Har-Noy says that one of the company’s flagship products, AlloVaxTM, has received full regulatory approval for a randomized, Phase I/II clinical trial in patients with recurrent head and neck cancer. This trial will evaluate both the safety and efficacy of this unique, individualized cancer vaccine in this gravely ill patient population that has no standard treatment options left. Dr. Michael Har-Noy says that this trial will be a 52 patient study, with 39 patients in the AlloVaxTM arm and 13 patients in the placebo group. The study will be conducted at the National Cancer Institute of Thailand. A sample of a patient’s tumor will be harvested and sent to Israel for production of the AlloVaxTM vaccine (purified chaperone proteins). The vaccine samples will then be returned to the clinical site for administration to the study patients. Dr. Michael Har-Noy adds that on days zero, seven, and 14, the patients will receive an intradermal vaccine combined with either AlloStimTM or placebo. On day 21, an infusion of either AlloStimTM or placebo will be administered. This process will be repeated for four complete cycles. Dr. Michael Har-Noy says that the patients will be tracked for radiological, pathological and immunological responses, overall survival, and quality of life. Other trials of Immunovative Therapies, Ltd.’s unique biologic compounds are being planned. Dr. Michael Har-Noy says that pivotal Phase II/III trials in metastatic breast cancer and in KRAS gene positive metastatic colon cancer are being designed.
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