Dr. Michael Har-Noy Details Remarkable Results Of A Phase I/II Trial Of AlloStimTM

21 Sep

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., an Israeli  biotechnology company founded in 2004, outlines the results of a U.S. FDA-approved Phase I/II trial of AlloStim combined with cryoablation in the treatment of 42 cancer victims with a wide variety of metastatic tumors. Dr. Michael Har-Noy plans to publish the trial data in a peer-reviewed journal.

This study was done in Carlsbad, California at one of Immunovative Therapies, Ltd.’s satellite locations.  Dr. Michael Har-Noy said that 42 metastatic cancer patients were subjected to the protocol.  All study patients were expected to live 60 days or less and had been pre-treated with large doses of radiation and/or chemotherapy.  The average patient was 61 years old; all had previous chemotherapy, 45% were previously irradiated, and 90% had already undergone surgery for their tumor.  Dr. Michael Har-Noy indicated the metastatic cancer types were: one bladder, two prostate, two esophageal, two lung, two sarcoma, two pancreas, three ovarian, three squamous cell, three gallbladder, seven colorectal, and 14 breast.  These severely ill cancer victims averaged 22.2 metastases and an ECOG (Eastern Cooperative Oncology Group) score of 2.2, indicating grave disability.

Dr. Michael Har-Noy said that the AlloStimTM caused only minor side effects in the study patients.  The most commonly documented adverse reaction, a minor flu-like syndrome, usually appeared two to three days after AlloStimTM injection.  There were no instances of anaphylactic reactions to the AlloStimTM.

The mean survival of the study group was 163 days – almost triple the expected survival in similar untreated cancer victims.  Dr. Michael Har-Noy said that even more remarkable was the fact that 20% of the study group was still in remission fully one year after the AlloStimTM treatment!  Some of these patients went on to survive years after the trial’s completion.  Dr. Michael Har-Noy says that this outcome, to date, is far superior than any published study involving similar patients.

Dr. Michael Har-Noy is preparing to publish these results in a peer-reviewed.  He adds that this trial’s outcome data must be interpreted with caution, as this was not a randomized, controlled study.  Dr. Michael Har-Noy is preparing to test AlloStimTM in a Phase II/III, randomized double-blind controlled trial involving heavily pre-treated breast cancer patients.

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