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

28 Sep

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., a biotech company in Israel, has developed a unique biologic, AlloStimTM, 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.  AlloStimTM is made from T-StimTM cells, which are created using unique, patented methods.

Michael Har-Noy says that T-StimTM cells are produced outside the body in a bioreactor. T-StimTM 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-StimTM cells can be manufactured.  There is no need to match donor to recipient, as AlloStimTM is intentionally mismatched to the patient receiving it.

To manufacture T-StimTM 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-StimTM cells for 100 patients.

Dr. Michael Har-Noy indicates that in this environment, the T-StimTM cells mature into memory CD4 cells that produce very high amounts of IL-2, IFN-g and TNF-a when activated.  Additionally, T-StimTM 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 tumor.

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

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


Dr. Michael Har-Noy is Patenting Technology Of Limitless Value

22 Sep

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, Ltd., Dr. Michael Har-Noy has developed a unique process he terms the “Mirror EffectTM. The Mirror EffectTM technology represents a break-through 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, Ltd. 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, Ltd.’s 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.

Dr. Michael Har-Noy Develops Unique Cancer Drugs

18 Sep

Physicians have been largely unsuccessful in treating patients with metastatic cancer. Medical scientists have made significant advances in early cancer diagnosis and prevention in the past two decades, but they have made relatively few inroads in treating advanced malignant disease.

The principle problem with current cancer therapies is that they usually cannot eradicate every cancer cell. Furthermore, as in the case of chemotherapy and radiation, they are often very toxic to the body and have unacceptable side effects. A young, daring biotech company named Immunovative Therapies Ltd., founded by Dr. Michael Har-Noy, is hoping to vastly improve the way cancer is treated. Dr. Michael Har-Noy is now testing groundbreaking drugs that enable one’s own immune system to kill metastatic cells.

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, describes their flagship product, AlloStimTM, as a biological drug synthesized from precursors found in the circulation of a normal donor. These precursors are then purified, differentiated, expanded, and then frozen until needed. When infused into a cancer patient’s blood these unique cells create an inflammatory environment which disarms tumor avoidance mechanisms. Because AlloStimTM cells are intentionally mismatched and are seen by the host as foreign, the patient’s own immune system “wakes up” to these danger signals and is able to both reject the AlloStimTM cells and kill the tumor cells.

Dr. Michael Har-Noy, using this patented “Mirror EffectTM” described above, has essentially produced the tumor-killing effect of a successful allogeneic bone marrow transplant without exposing the patient to the lethal problem of graft versus host disease.

Preliminary Phase I/II data shows that AlloStimTM has a remarkable antitumor effect across a wide variety of metastatic cancers. A Phase II/III trial of AlloStimTM in the treatment of metastatic breast cancer will hopefully be under way soon in Thailand. With his unique biologic drugs, Dr. Michael Har-Noy may be on the verge of creating an entire new field of oncology.

Dr. Michael Har-Noy Develops Cutting Edge Cancer Treatments

10 Sep

For a new biotech company, developing and marketing new drugs can be an arduous task.  The many government regulations that exist in most countries can be very costly and time consuming to comply with.  Frequently, small companies don’t survive the startup process because they run out of money before they are able to bring any new products to market.

Sometimes, however, smaller biotech startup companies develop new therapies that are far more innovative than those manufactured by giant multinational corporations.  Immunovative Therapies Ltd., an Israel-based biotech company founded by Dr. Michael Har-Noy, has, on a very limited budget, developed remarkable cutting-edge products that may change the way cancer is treated.  They may, in the near future, be ready to bring these drugs to market.

Adjuvant treatment today for metastatic cancer still relies primarily on chemotherapy and radiation.  These therapies are very toxic, causing devastating side effects and dramatically worsening patients’ quality of life.  Preliminary work done by Dr. Michael Har-Noy of Immunovative Therapies has shown that immune-based therapy may be far more effective than these treatments and may have comparatively few side effects.

Currently, Dr. Michael Har-Noy is developing AlloStimTM, CryostimTM, and AlloVaxTM, which are complex and unique compounds specially designed to “wake up” the body’s immune system and help it attack cancer cells.  Preliminary results in a Phase I/II trial have shown remarkable efficacy of these compounds against a wide variety of tumors.  Furthermore, these proprietary drugs appear to have minimal toxicity to the patient.  Immunovative Therapies has also obtained regulatory approval in Thailand to conduct a double-blind, randomized Phase II/III trial of AlloStimTM in the treatment of metastatic breast cancer.

These prototype compounds being tested by Dr. Michael Har-Noy appear to be far more effective in killing metastatic tumors and far less toxic to normal cells than are conventional treatments.  They have the potential to create an entire new industry of oncologic therapy.

Dr. Michael Har-Noy Will Soon Start A Phase II/III Trial In Colorectal Tumors

19 Aug

Dr. Michael Har-Noy plans tostart a pivotal Phase II/III randomized study of AlloStim TM in the therapyof metastatic KRAS gene positive colon tumors. Dr. Michael Har-Noy notes there is no approved third line treatment forthese patients.  A favorable outcome ofthis study would likely lead to FDA marketing approval for AlloStim TM.  Dr. Michael Har-Noy intends to start thestudy in the United States as well as two other international sites.

via Dr. Michael Har-Noy Will Soon Start A Phase II/III Trial In Colorectal Tumors.

Dr. Michael Har-Noy Compares Checkpoint Blockade To AlloStimTM

29 Jul

Dr. Michael Har-Noy of Immunovative Therapies, Ltd. says that checkpoint blockade compoiunds block a molecule used by tumor cells to turn off immune cells that are primed and ready to kill. Yervoy blocks the molecule CTLA-4 and Opdivo blocks a molecule named PD-1. When these molecules are neutralized, immune cells can see and kill the cancer cells.

However, Dr. Michael Har-Noy says that these blockade drugs only work if the patient has an intact immune response that can eliminate the cancers. Most cancer patients have an ineffective immune response and for this reason the response rates of checkpoint blockade compounds has been poor and is restricted to cancers, such as melanoma, that are very immunogenic.

Dr. Michael Har-Noy has created an innovative technology that may be effective in treating most types of tumors and infectious diseases. This technology is completely different from previously tested immunotherapies. Instead of being conceptualized first in animals and then in humans, Dr. Michael Har-Noy’s unique platform was reverse engineered from a known human immune response that has already been shown to be capable of eradicating chemotherapy-resistant metastatic tumors and that has been curative in many instances.

The immune reaction resulting from the transplantation of a person’s immune cells (adult stem cells) into a cancer patient has been described as the most potent anti-tumor mechanism ever discovered. Dr. Michael Har-Noy says that this reaction, called the “graft vs. tumor” effect or “GVT”, is the only known mechanism that can, without surgery, debulk chemotherapy-resistant metastatic cancer. However, the clinical utility of the GVT effect is drastically limited due to its often lethal complication called “graft vs. host disease” or “GVHD” which is closely associated with the GVT cascade. The separation of the curative GVT mechanism from the detrimental GVHD effect has been referred to as the “holy grail” of transplantation. Dr. Michael Har-Noy has synthesized a compound called AlloStimTM that uses the proprietary “Mirror EffectTM” technology to mimic the curative effect of a transplant without GVHD toxicity

Dr. Michael Har-Noy Says That The Battle Against Cancer Is Being Lost

20 Jul

Dr. Michael Har-Noy, CEO of Immunovative Therapies, a biotech company started in Israel in 2004, says that we are losing the fight against cancer. Dr. Michael Har-Noy indicates that over the past 3 decades, the incidence of cancer has increased markedly, affecting about one out of every three females and one out of every two males.. This means that the present rate of occurrences of new cancer cases is 50% higher in men and 25% higher in women than in the previous generation. The National Cancer Institute predicts that, because of our increasingly elderly population, the number of new malignancy cases will almost double by the year 2050.

Dr. Michael Har-Noy says that despite years of clinical research, decreases in mortality from cancer have been minimal, and significant reductions in death rates are primarily due to decreases in lung cancer deaths secondary to less smoking in the population, and not from real advances in cancer therapies. Also, Dr. Michael Har-Noy notes that the total five-year survival rate of about 50% for all cancer cell types is virtually the same as it was in 1970.

Conventional cancer treatments have extremely negative emotional and physical effects on patients. Many feel that the treatment is worse than the disease. The financial burden that cancer therapies place on our culture is profound.  Dr. Michael Har-Noy says that the direct annual cost of cancer therapy has almost quadrupled over the past 20 years. It has grown from about $18 billion in 1985 to $41 billion in 1995, and then to an immense $80 billion in 2005. Dr. Michael Har-Noy adds that in 1999, indirect costs from tax increases, wage losses, reduction in overall productivity secondary to cancer was a staggering $100 billion.

At Immunovative Therapies, Ltd., Dr. Michael Har-Noy synthesizes unique biologic drugs that stimulate one’s own immune system to attack malignant cells. Preliminary results of a Phase I/II trial show remarkable efficacy of these drugs against many different tumor cell types. Pivotal randomized Phase II/III trials of these new therapies are being planned.