Dr. Michael Har-Noy Describes Upcoming Phase II/III AlloStimTM Breast Cancer Trial

11 Jun

Dr. Michael Har-Noy, founder and CEO of Immunotherapies, Ltd., says that in light of the unexpected positive results in patients that had exhausted all treatment options in a previous Phase I/II clinical trial, Immunovative Therpies, Ltd. has received full regulatory approval to advance AlloStimTM to a pivotal Phase II/III licensing trial. Dr. Michael Har-Noy notes that this will be a randomized, double-blind, placebo-controlled clinical trial in patients with advanced metastatic breast cancer. The patients will have been previously treated with a taxane, anthracycline and capecitabine. Her2+ patients will be pre-treated with a Herceptin-containing protocol. Dr. Michael Har-Noy goes on to say that a total of 208 patients will be recruited, with 104 receiving AlloStimTM and 104 receiving a placebo compound. The study will take approximately two years to complete enrollment. The trial will be conducted at the National Cancer Institute of Thailand. Dr. Michael Har-Noy says that the primary end-point will be overall survival (OS). Patients are treated with four intradermal AlloStimTM (or placebo) injections on days zero, four, seven, and ten. On day 14, all patients undergo a cryoablation procedure targeting one metastatic lesion and either AlloStimTM or placebo is then infused into the ablated lesion. On day 17, says Dr. Michael Har-Noy, AlloStimTM or placebo is again injected into the previously ablated lesion. On day 21, an intravenous infusion of AlloStimTM or placebo is again administered. Booster IV infusions of AlloStimTM or placebo are administered again on days 49, 77 and 105. Dr. Michael Har-Noy notes that the study is powered at 80% to detect a 50% or greater difference in OS between the arms at a significance level (alpha) of 0.05. Secondary end-points include Quality of Life and immunological response.   If the overall survival in the treatment group is significantly longer than the placebo, says Dr. Michael Har-Noy, these data will be used to support US marketing application under rule 21 CFR 312.120. The data can also be used to support marketing applications in Canada, Japan and the EU.

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