Dr. Michael Har-Noy of Immunovative Therapies, Ltd., Details Positive Results in Breast Cancer Patients
Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., says that the immune response of an allogeneic bone marrow transplant very effectively kills chemo-resistant tumor cells despite their immune avoidance mechanisms. However, he notes that this mechanism often precipitates the deadly graft versus host disease (GVHD) and is therefore of limited clinical usefulness.
Dr. Michael Har-Noy of Immunovative Therapies Ltd. has created a unique drug, AlloStimTM, which can elicit a host anti-cancer immune response without GVHD toxicity. Dr. Michael Har-Noy tested AlloStimTM in an FDA-approved phase I/II trial of 42 patients with a variety of late-stage solid metastatic cancers. Most of these demonstrated enhanced survival and immune-mediated cancer elimination without GVHD toxicity. Traditional RECIST scoring methods overestimated tumor size, as responding cancers developed edema and appeared larger when evaluated using computed tomography.
Plasma interleukin 12 (IL-12) levels, says Dr. Michael Har-Noy, appeared to be a predictor of improved survival. Fifty percent of patients treated with Immunovative Therapies, Ltd.’s compounds were IL-12 positive and lived a median of 211 days, compared with 131 days for the IL-12 negative subjects. Nine of 16 metastatic breast cancer patients showed IL-12 positivity. The HER2+ subset of 5 patients were all IL-12 positive and survived a median time of 416 days, while the 11 HER2- survived a median time of 134 days
Dr. Michael Har-Noy notes that HER2+ tumors are usually more aggressive and have a poorer prognosis than HER2- malignancies. The improved response to AlloStimTM in the HER2+ breast cancer patients might result from high quantities of anti-HER2 antibodies present in their serum. Hypothetically, says Dr. Michael Har-Noy, the AlloStimTM potentiates the ability of these antibodies to kill malignant cells.
This preliminary study details a remarkable increase in survival in a group of gravely ill cancer patients with a very short life expectancy. Dr. Michael Har-Noy of Immunovative Therapies, Ltd. will soon conduct a pivotal Phase II/III trial of AlloStimTM in KRAS-gene positive colon cancer patients.