Archive | June, 2014

Dr. Michael Har-Noy Describes Benefits of AlloStimTM in Metastatic Breast Cancer Patients

30 Jun

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., indicates that the that the immune cascade precipitated by an allogeneic stem cell transplant has been shown to be efficacious in eradicating chemotherapy-resistant metastatic tumors in spite of their immunoavoidance mechanisms, but this beneficial immune response is closely linked to lethal graft versus host disease (GVHD) toxicity and is therefore limited in clinical sue.

Dr. Michael Har-Noy has engineered the unique compound AlloStimTM that is designed to create a host anti-tumor response without causing the potentially lethal GVHD side effect. Dr. Michael Har-Noy says that AlloStimTM has been preliminarily tested in an FDA-approved phase I/II study involving 42 late-stage metastatic cancer patients with solid tumors of various different cell types.   Dr. Michael Har-Noy indicated that most of the study patients demonstrated evidence of improved survival and exhibited immune-mediated killing of malignant cells without GVHD toxicity. Conventional RECIST criteria tended to overestimated tumor size because responding masses swelled and appeared to increase in size on computed tomographic scan.

Dr. Michael Har-Noy notes that serum interleukin 12 (IL-12) levels seemed to predict improved survival.   Fifty percent of the study patients treated with AlloStimTM were positive for IL-12 and survived a median of 211 days, as compared with a median longevity of 131 days for IL-12 negative patients.   Nine of 16 patients with refractory metastatic breast tumors were positive for IL-12. Dr. Michael Har-Noy noted that the subset of five HER2+ breast cancer patients all manifested IL-12 positive and had a median survival of 416 days. In contrast, the 11 HER2- study patients had a median survival of only 134 days; four of these eleven patients were IL-12 positive.

Dr. Michael Har-Noy indicates that HER2+ breast cancers are usually very aggressive and have a much worse prognosis than their HER2- counterparts. The superior response to AlloStimTM of the HER2+ breast cancer study patients could be due to the high levels of anti-HER2 antibodies that they exhibit.  Dr. Michael Har-Noy concludes that the AlloStimTM therapy likely augments the ability of these anti-HER2 antibodies to destroy malignant tissue.

This preliminary report describes dramatically improved survival in a gravely ill subset of cancer patients with a very short life expectancy. Dr. Michael Har-Noy is planning to undertake a randomized, double blind Phase II/III study of AlloStimTM in patients with metastatic breast cancer.