Dr. Michael Har-Noy, founder and CEO of Immunotherapies, Ltd., says that Immunovative Therpies, Ltd. has received full regulatory approval to advance AlloStimTM to a pivotal Phase II/III licensing trial. Dr. Michael Har-Noy says that this will be a randomized, double-blind, placebo-controlled clinical trial in patients with metastatic breast cancer. Dr. Michael Har-Noy goes on to say that a 208 total patients will be recruited, with 104 receiving AlloStimTM and 104 receiving placebo. The trial will be conducted at the National Cancer Institute of Thailand. Dr. Michael Har-Noy says that overall survival (OS) will be the primary end-point. Patients will be treated with four intradermal AlloStimTM (or placebo) injections followed by a cryoablation procedure targeting one metastatic lesion after which either AlloStimTM or placebo is injected into the cryoablated lesion. Booster AlloStimTM infusions will follow on pre-determined days. Dr. Michael Har-Noy notes that overall survival will be the primary endpoint, whiles econdary end-points will include immunological response and overall quality of life. If the overall survival in the treatment group is significantly longer than that in the control patients, says Dr. Michael Har-Noy, these data will be used to apply for US marketing.

Dr. Michael Har-Noy says that another of the company’s flagship products, AlloVaxTM, has received full regulatory approval for a randomized, Phase I/II trial in advanced head and neck cancer patients. This study will test the safety and efficacy of this unique, individualized cancer vaccine in a gravely ill patient population that has no standard treatment options left. Dr. Michael Har-Noy says that this study will be enroll 52 patients, with 39 patients in the AlloVaxTM group and 13 patients in the placebo arm. The study will also be conducted at the National Cancer Institute of Thailand. A sample of a patient’s tumor will be sampled and sent to Israel AlloVaxTM vaccine production. The vaccine samples will then be returned to the study site for use in the protocol patients. Dr. Michael Har-Noy adds patients will receive, on a set schedule, intradermal vaccine combined with either AlloStimTM or placebo, followed by intravenous infusion of either AlloStimTM or placebo. This process will be repeated for four complete cycles. Dr. Michael Har-Noy says that the patients will be evaluated for radiological, pathological and immunological responses, overall survival, and quality of life.

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