Archive | July, 2013

Dr. Michael Har-Noy of Immunovative Therapies Introduces AlloVax™, a New Cancer Vaccine

23 Jul

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, describes AlloVax™ as a new drug under development that combines the product AlloStim™ with a vaccine formulation containing chaperone or heat shock proteins isolated from a piece of a patient’s tumor. This vaccine may be used in patients with hematological malignancies that are eligible for first-line chemotherapy and radiation. Most patients with these cancers will achieve remission with conventional radiation and chemotherapy, but almost all will subsequently suffer a relapse.

Allogeneic bone marrow transplant is the only curative procedure left for these patients, but the high toxicity associated with this procedure and the need for a matched donor limit its use.

Dr. Michael Har-Noy goes on to explain that AlloVax™ is an individualized anti-tumor vaccine that educates the patient’s immune system during the period of remission to prevent the cancer from returning. Chaperone proteins isolated from malignant cells have been shown to carry tumor antigens that may be used to train a patient’s immune system to recognize and kill the cancer cells they came from. Immunovative Therapies has acquired the exclusive rights to use a patented method developed by Dr. Emmanual Katsanis at the University of Arizona to isolate these chaperone proteins from tumor tissue.

To start the AlloVax™ protocol, tumor cells are removed from the patient prior conventional treatment. When the patient achieves remission, intradermal injections of Immunovative Therapies’ AlloStim™ compound are given. The AlloStim™ is rejected by the patient’s immune system, thereby making the patient immune to the AlloStim™ cells. Chaperone proteins containing the unique tumor antigens are then processed from the patient’s cancer cells that were sampled prior to radiation and/or chemotherapy.

These chaperone proteins are then injected intradermally along with the AlloStim™. The AlloStim™ helps stimulate chaperone protein vaccine formulation, thereby causing an immune response to reject the AlloStim™ and a simultaneous response against the unique tumor antigens carried by the chaperone proteins. Dr. Michael Har-Noy indicates that the powerful combination of these two responses educates the host immune system that the tumor antigens are dangerous. Therefore, if the cancer recurs, the patient’s immune system is ready to kill the tumor cells and keep the patient in remission.

Dr. Michael Har-Noy Describes the Development of AlloStim™ – A New Cancer Drug

23 Jul

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd., a biotech company in Israel, has developed a unique biologic, AlloStim™, which stimulates a patient’s immune response to attack tumor cells. This enables a patient’s own immune system to scavenge and destroy all metastatic cells. AlloStim™ is made from T-Stim cells, which are created using unique, patented methods.

Dr. Michael Har-Noy says that T-Stim cells are produced outside the body in a bioreactor. T-Stim cells are produced from T-cell precursors isolated from the blood of normal donors. Typically, 100 million of these cells can be made from one normal donor’s blood. After a nine day culture process, approximately 10 billion T-Stim cells can be manufactured. There is no need to match donor to recipient, as AlloStim™ is intentionally mis-matched to the patient receiving it.

To manufacture T-Stim cells, Dr. Michael Har-Noy says that naïve CD4 cells are cultured on a medium coated with anti-CD3 and anti-CD28 monoclonal antibodies. These antibodies, as well as cell-to-cell contact, cause activation and maturation of the CD4 cells. The cells multiply at least 100-fold during the culture process, enabling one donor to produce enough T-Stim cells for 100 patients.

Dr. Michael Har-Noy indicates that in this environment, the T-Stim cells mature into memory CD4 cells that produce very high amounts of IL-2, IFN-g and TNF-a when activated. Additionally, T-Stim cells express high amounts of CD40L and FasL (a transmembrane protein) on the cell surface. CD40L interacts with the patient’s innate CD40 immune cells and stimulates these cells to produce Th1 cytokines that kill malignant cells. The FasL enables the patient’s immune cells to kill tumors.

Dr. Michael Har-Noy adds that in order to produce the Mirror EffectTM, the name Immunovative Therapies has given to this novel method of immune manipulation, the T-Stim cells need activation prior to infusion into the patient. T-Stim cells are activated with monoclonal antibody-coated beads that are then filtered out before infusion. “AlloStim™” is the name given to the formulated and activated T-Stim cells.

Dr. Michael Har-Noy says that he is preparing to test AlloStim™ in a Phase II/III double-blind randomized trial of pre-treated metastatic breast cancer patients.

Dr. Michael Har-Noy and Immunovative Therapies – Patenting Technology Of Limitless Value

20 Jul

Conventional cancer treatment methods, such as surgery, chemotherapy, and radiation, do not have the ability to target and kill metastatic tumor cells wherever they reside in the patient’s body. However, Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd, a biotech company in Israel, says that the human immune system, if properly manipulated, may be capable of doing this. Dr. Michael Har-Noy goes on to state that if one could harness the ability of a patient’s immune system to target and eliminate metastatic cells, the result may be an actual complete cure.

 

At Immunovative Therapies, Dr. Michael Har-Noy has developed a unique process he terms the “Mirror EffectTM.” The Mirror EffectTM technology represents a breakthrough in our ability to target tumors with direct immune responses and to disrupt the ability of cancer cells to avoid these responses. The development of the Mirror EffectTM and the synthesis of compounds that utilize it have the potential to spawn an entire new industry of medicine. Dr. Michael Har-Noy goes on to indicate that by patenting this technology properly, his company can create immensely profitable and marketable drugs.

 

Dr. Michael Har-Noy and his team at Immunovative Therapies have been working with their patent attorneys to build a portfolio that captures the immense depth and scope of the Mirror EffectTM and characterizes its use to manipulate the immune system to treat some of the most refractory diseases described in modern medicine. Dr. Michael Har-Noy indicates that the patent portfolio Immunovative Therapies is developing will not only involve protection of the company’s products and manufacturing techniques but will have the potential to create a completely new industry based on controlling and manipulating the human immune system.

 

Ultimately, Immunovative Therapies’ patent portfolio will likely introduce a new field of oncology and completely change the way cancer is treated. Dr. Michael Har-Noy believes that this new technology will therefore be of virtually limitless value

Prolonged Survival in Metastatic Canine Cancer Using Immunovative Therapies’ CRCL Vaccine

13 Jul

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, describes a case in which a 12-year-old Great Dane presenting with primary bronchoalveolar adenocarcinoma, with a life expectancy no greater than 1 month, survived over 50 weeks post-diagnosis after being treated with Immunovative Therapies’ unique chaperone-rich-cell-lysate (CRCL) vaccine.

 

Prior to treatment by Immunovative Therapies, the Great Dane presented with ataxia, nystagmus, and hind-end collapse. Chest X-rays showed a nodule in the cranial lobe of the right lung. An ultrasound-guided fine needle biopsy showed bronchoalveolar adenocarcinoma, and the dog underwent thoracotomy and lobectomy. The specimen’s pathology report showed grade III bronchoalveolar adenocarcinoma with lymph node metastasis and vascular infiltration. The average survival for this tumor is 6 – 27 days.

 

Using Immunovative Therapies’ proprietary technology, a 10-gram piece of tumor was incorporated into a CRCL vaccine, which was administered weekly to the Great Dane. Additionally, Imiquimod – a Toll-like receptor 7 (TLR7) agonist – was topically administered to the dog for the first 12 treatments to stimulate local Langerhans cells. Furthermore, a single Bacillus Calmette-Guerin (BCG) shot was given at 30 weeks of treatment to further stimulate the dog’s immune response.

 

The Great Dane remained stable and in otherwise good health until it relapsed 44 weeks after the first treatment with Immunovative Therapies’ CRCL vaccine. The dog then suffered severe gastrointestinal bleeding and was euthanized just after 50 weeks post diagnosis.

 

Dr. Michael Har-Noy says that to his knowledge, this is the first report of significantly improved survival following a diagnosis of grade III/stage III bronchoalveolar adenocarcinoma in a canine patient. This case suggests that Immunovative Therapies’ CRCL vaccine combined with topical imiquimod is a safe and very effective treatment for canine cancer.

 

Immunovative Therapies Ltd. is a biotech company founded in Israel in 2004 by Dr. Michael Har-Noy. Immunovative Therapies manufactures unique compounds that focus on manipulating the immune system to fight cancer.

Dr. Michael Har-Noy of Immunovative Therapies Ltd., Reports Remarkable Results in Breast Cancer Treatment

4 Jul

Dr. Michael Har-Noy states that the immune mechanism of an allogeneic stem cell transplant has been shown to be effective in killing chemotherapy-resistant metastatic cancer cells despite the presence of immunoavoidance mechanisms, but this immune effect is closely tied to lethal graft versus host disease (GVHD) toxicity, therefore limiting its clinical use.

Immunovative Therapies Ltd., a biotech company in Israel, has developed a proprietary compound, AlloStim™, that was designed to elicit a host anti-tumor response without GVHD side effects. Dr. Michael Har-Noy describes how drug was recently evaluated in an FDA-approved phase I/II trial of 42 late-stage metastatic solid tumor patients with a variety of cell types. Most patients in the trial showed evidence of enhanced survival and immune-mediated tumor destruction without GVHD toxicity. Conventional RECIST criteria overestimated tumor size, as responding tumors swelled and appeared larger on computed tomographic scan.

Serum interleukin 12 (IL-12) levels were identified as a predictor of enhanced survival. Fifty percent of patients treated with Immunovative Therapies’ proprietary compound were IL-12-positive and survived a median of 211 days, as opposed to 131 days for those that were IL-12-negative. Nine of 16 refractory metastatic breast cancer patients were IL-12 positive. The Her2-positive subset of breast cancer patients (five of them) were all IL-12 positive and had a median survival of 416 days, while the 11 Her2-negative patients had a median survival of only 134 days.

Dr. Michael Har-Noy indicates that Her2-positive tumors usually spread faster and have a worse prognosis than Her2-negative cancers. The superior response to allogeneic cell treatment in the Her2 positive metastatic breast cancer patients may be due to high quantities of anti-Her2 antibodies present in this subset of patients. Hypothetically, the allogeneic cell treatment potentiates the ability of these antibodies to cause tumor destruction.

This preliminary report describes a remarkably prolonged survival time in a gravely ill subset of cancer patients with an extremely short life expectancy. Immunovative Therapies is preparing to conduct a randomized, double-blind Phase II/III study of this unique treatment in metastatic breast cancer patients.