Archive | September, 2013

Dr. Michael Har-Noy Details the Synthesis of AlloStimTM – A Revolutionary Cancer Drug

27 Sep

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd., an Israeli biotechnology company, has created a revolutionary new drug, AlloStimTM, which enables a patient’s immune system to attack cancer cells.  This new compound, when administered to a patient, facilitates the destruction of metastatic tumors by the patient’s own immune cells.  Dr. Michael Har-Noy says that AlloStimTM is synthesized from T-StimTM cells, which are made using a proprietary, patented process.

Dr. Michael Har-Noy describes the T-StimTM cells as being made in vitro in a bioreactor. These T-StimTM cells are manufactured from T-cell precursors obtained from the serum of normal human donors.  On the average, 100 million T-StimTM cells can be made from one person’s donor blood. After nine days of culturing, about 10 billion T-StimTM cells can be produced.  Dr. Michael Har-Noy reminds us that there is no need to match the donor to the recipient, as AlloStimTM is deliberately mismatched to the person receiving it.

To make T-StimTM cells, Dr. Michael Har-Noy says that  CD4 cells are cultured in medium covered with anti-CD3 and anti-CD28 monoclonal antibodies.  These monoclonal antibodies, and the cell-to-cell contact, activate the CD4 cells and enable them to mature.  The cells grow by a minimum of 100-fold throughout the culturing, thus permitting one donor to supply 100 patients with T-StimTM cells.

Dr. Michael Har-Noy says that in this carefully engineered environment, the T-Stim cells develop into memory CD4 cells that, when activated, secrete very large quantities of IL-2, IFN-g and TNF-a.  Also, high amounts of CD40L and FasL (a trans-membrane protein) are expressed on the T-StimTM cell membrane.  Dr. Michael Har-Noy indicates that the CD40L reacts with the patient’s own CD40 cells and enables them to kill malignant cells by producing Th1 cytokines.  The patient’s immune cells kill the cancer cells with the help of the FasL.

Dr. Michael Har-Noy adds that in order to create the “Mirror EffectTM”, the proprietary name given to method of immune modulation, the T-StimTM cells must be activated before being infused into a patient.  This is done using monoclonal antibody-coated beads which are then removed before the compound is administered.  The formulated and activated T-StimTM cells are called “AlloStimTM”.

Dr. Michael Har-Noy will soon test AlloStimTM in a Phase II/III double-blind randomized trial involving patients with pre-treated metastatic breast cancer

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.

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.

Dr. Michael Har-Noy Says That Medicine Is Losing The Battle Against Cancer

14 Sep

“Medicine is losing the fight against cancer” says Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, an Israeli biotechnology firm founded in 2004.  Dr. Michael Har-Noy points out that in past thirty years, the incidence of new human malignancies has grown astronomically, affecting nearly one out of two males and one of three females worldwide. Dr. Michael Har-Noy also says that the current cancer rate is 50% higher in males and 25% higher in females than in the last generation.  Physicians at the National Cancer Institute believe that by the year 2050, the incidence of malignant tumors will virtually double.

Dr. Michael Har-Noy goes on to say that in spite of many years of clinical studies and scientific research, improvement in the overall cancer death rate has been negligible, and that reductions in mortality that have been documented are largely secondary to decreased lung cancer deaths from less smoking in the male population – not from improvements in cancer treatments.  Dr. Michael Har-Noy reminds us that the five-year survival rate for all tumors is still about 50% – almost identical to what it was back in 1970.

“Conventional cancer therapy, namely surgery, chemotherapy, and radiation, does tremendous physical and emotional damage to the patient” says Dr. Michael Har-Noy.  Many patients say that traditional cancer treatments are worse than the tumor itself.  Furthermore, the financial strain placed on the medical profession for treating metastatic tumors is astronomically great.  Dr. Michael Har-Noy says that over the past 20 years, the overall estimated yearly cost of cancer therapy has more than quadrupled.  This cost has ballooned to an unbelievable $80 billion in 2005, up from $41 billion in 1995 and $18 billion in 1985.  Furthermore, additional costs due to loss of taxes, wages, and general productivity secondary to metastatic cancer was approximately $100 billion in 1999.

At Immunovative Therapies, Dr. Michael Har-Noy is developing unique drugs that stimulate one’s own immune cells to seek out and kill malignant tumors.  Initial results of a Phase I/II trial indicate that these drugs are very active against many different types of cancers.  Dr. Michael Har-Noy says that definitive randomized Phase II/III trials of these proprietary compounds will soon begin.