Dr. Michael Har-Noy Reports Remarkable Results in Treating Breast Cancer Victims

24 Sep

Dr. Michael Har-Noy says that the immunologic reaction precipitated by a successful bone marrow transplant has been shown to eradicate chemotherapy-resistant tumor cells in spite of their immune-avoidance ability, but that this successful mechanism also precipitates the often-fatal graft-versus-host disease (GVHD) complication and is therefore of limited clinical utility.

Dr. Michael Har-Noy and his company Immunovative Therapies, Ltd., have created a unique biologic drug, AlloStimTM, that stimulates a patient’s anti-tumor mechanism while avoiding GVHD.  Dr. Michael Har-Noy said that AlloStimTM has been tested in an FDA-approved Phase I/II trial involving 42 patients with a variety of advanced solid tumors with an average of 22.2 metastatic lesions.   Most study patients demonstrated improved survival and showed immune-modulated tumor destruction with only minor side effects.  Dr. Michael Har-Noy indicated that standard RECIST criteria overestimated the dimensions of the metastatic lesions, as these masses usually swelled after treatment and appeared larger on computed tomographic scan.

Dr. Michael Har-Noy said that serum interleukin 12 (IL-12) levels appeared to correlate with improved survival.   Fifty percent of patients treated using the AlloStimTM-cryoablation study protocol were IL-12 positive and lived a median of 211 days, as opposed to 131 says for the IL-12 negative patients.  Dr. Michael Har-Noy also said that nine of 16 metastatic breast cancer patients who failed prior treatment were IL-12 positive.  The median survival of the subset of five HER2 positive breast cancer patients, all of whom were IL-12 positive, was a remarkable 416 days.  In contrast, median survival was only 134 days for the 11 HER2 negative patients.

Dr. Michael Har-Noy points out that HER2 positive breast cancers usually metastasize more quickly and have a poorer outcome than HER2 negative tumors. The HER2 positive patients probably responded so well to allogeneic cell therapy because they possess large amounts of anti-HER2 antibodies.  Dr. Michael Har-Noy indicates that the administration of AlloStimTM likely enhances the ability of these antibodies to kill the cancer cells.

In this preliminary trial, a subset of patients with very advanced metastatic tumors exhibited dramatically improved survival when treated with AlloStimTM.  Dr. Michael Har-Noy is planning to carry out a randomized, double-blind Phase II/III trial of AlloStimTM in pre-treated metastatic breast cancer patients.

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