Dr. Michael Har-Noy, CEO of Immunovative Therapies, Ltd., says that the “Mirror EffectTM” is an immune reaction that addresses the problem of uncoupling the curative graft versus tumor (GVT) effect of an allogeneic bone marrow transplant (BMT) from the deadly graft versus host disease (GVHD) side effect.
Dr. Michael Har-Noy says that he solved this problem by designing a T-cell infusion that mimicked the immune cascade caused by the transplanted donor cells but that was controlled by the immune mechanism of the patient. This process, termed the “Mirror EffectTM”, could potentially recreate the curative effect of a BMT without the deadly side effects.
The Mirror EffectTM treatment, says Dr. Michael Har-Noy, reverses the closely linked GVT and GVHD mechanisms that come from the infused bone marrow graft. This effect thus stems from the host rather than from transplanted cells, thus causing a host versus tumor (HVT) response that is closely linked to the benign host versus graft (HVG) rejection. To initiate the Mirror EffectTM, normal T-cells are infused into a cancer patient. These cells then cause the patient’s own immune cells to attack the cancer (HVT effect) and cause an inflammatory reaction which neutralizes the immunoavoidance mechanisms of the cancer.
Dr. Michael Har-Noy indicates that since the HVT mechanism must be linked to a HVG rejection, the patient needs an immune system that is strong enough to reject the donor T-cells. Also, since graft rejection (HVG) is required, the donor cells need to be mismatched to the recipient. This is an immense improvement over allogeneic BMT, where only one third of eligible patients can find an appropriately matched donor.
The Mirror EffectTM therefore involves administration of unmatched cells into a cancer patient who has not been pretreated, so that these foreign cells can be rejected by the patient’s immune system. Dr. Michael Har-Noy says that this HVG mechanism is the “mirror” of the deadly GVHD but is not harmful. The HVG rejection starts the host-mediated tumor destruction (HVT), which is the “mirror” of the GVT mechanism. The “mirror” effect mimics the curative GVT mechanism of BMT while at the same time avoiding the deadly toxicity of GVHD.
Dr. Michael Har-Noy thinks that the “Mirror EffectTM” may start an entirely new field of cancer therapy.
Traditional techniques of cancer therapy, such as surgery, radiation, and chemotherapy, cannot eliminate every metastatic malignant cell in the body. Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd, an Israeli biotechnology firm, says, however, that the immune system can be manipulated do just that. Dr. Michael Har-Noy indicates that a real cure could result if one could direct a patient’s own immune cells to eradicate malignant tumors.
Dr. Michael Har-Noy of Immunovative Therapies, Ltd. has formulated a proprietary process he which he calls the “Mirror EffectTM. The Mirror EffectTM represents a significant advance in our ability to eliminate cancer cells via the immune system and to neutralize the malignant tumor’s ability to evade this response. The Mirror EffectTM technology may stimulate the creation of a new field of cancer treatment. Dr. Michael Har-Noy says that by properly patenting the Mirror EffectTM, Immunovative Therapies, Ltd. could create a hugely profitable business.
Dr. Michael Har-Noy and his colleagues at Immunovative Therapies, Ltd. are working with their patent lawyers to build a portfolio that protects the entire scope of the Mirror EffectTM and defines its use to guide the immune system to treat some of medicine’s the most difficult conditions. Dr. Michael Har-Noy adds Immunovative Therapies, Ltd.’s patent portfolio will not only protect the company’s products and manufacturing methods but may also create a new industry based on immune manipulation as a medical treatment.
Ultimately, says Dr. Michael Har-Noy, Immunovative Therapies, Ltd.’s patent portfolio will probably change modern cancer treatment. Dr. Michael Har-Noy believes that the potential value of this technology is limitless.
“We are losing the fight against cancer” says Dr. Michael Har-Noy, CEO of Immunovative Therapies, a young biotech firm started in Israel in 2004. Dr. Michael Har-Noy indicates that in past 30 years, the incidence of cancer has increased dramatically, affecting almost one out of every three females and one out of every two males.. This means that the current rate of cancer is 50% higher in men and 25% higher in women than in the past generation. The National Cancer Institute predicts that, because of our growing elderly population, the number of cancer cases will virtually double by the year 2050.
Dr. Michael Har-Noy says that in spite of years of clinical trials and research, decreases in overall mortality from cancer have been minimal, and noted reductions in death rates are largely due to decreases in lung cancer deaths secondary to a lower incidence of smoking, and not from true breakthroughs in cancer treatment. Also, Dr. Michael Har-Noy says that the total five-year survival rate of about 50% for all cancer cell types is almost identical to what it was in 1970.
Conventional cancer therapies have devastating emotional and physical effects. Many patients feel that the treatment is worse than the disease. The financial burden that cancer treatment places on society is also staggering. Dr. Michael Har-Noy notes that the approximate direct annual cost of cancer therapy has quadrupled over the past 2 decades. It has ballooned from about $18 billion in 1985 to $41 billion in 1995, and then to a gigantic $80 billion in 2005. Dr. Michael Har-Noy notes that indirect costs from wage losses, tax increases, and decreases in overall productivity secondary to cancer was a staggering $100 billion in 1999.
At Immunovative Therapies, Ltd., Dr. Michael Har-Noy creates novel biologic treatments that stimulate one’s own immune system to attack cancer cells. Initial results of a Phase I/II trial show amazing efficacy of these drugs across a wide range of tumors. Definitive randomized Phase II/III trials of these new treatments are in the works.
Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd., says that the “Mirror EffectTM” is a proprietary immunologic treatment that has finally been able to separate the beneficial graft versus tumor (GVT) response of an allogeneic bone marrow transplant (BMT) from the deadly graft versus host (GVHD) complication. The separation of the GVT and GVHD processes has been called the “Holy Grail” of cancer treatment.
Dr. Michael Har-Noy tells us that the answer was to design a T-cell infusion that would mimic the immunologic responses caused by the transplanted donor cells but that would be ultimately controlled by the patient’s own immune cells. This proprietary response, termed the “Mirror EffectTM”, could theoretically produce the curative response of a BMT without the lethal complication of GVHD.
Dr. Michael Har-Noy says that the Mirror EffectTM process reverses the intimately related GVT and GVHD mechanisms that arise from the infused donor cells. This effect thus arises from the host immune response rather than from the transplanted cells, thus precipitating a host versus tumor (HVT) response that is associated with the non-toxic host versus graft (HVG) rejection process. To initiate the Mirror EffectTM reaction, T-cells from a normal donor are infused into a cancer patient. Dr. Michael Har-Noy says that these infused cells prompt the patient’s immune response to attack the malignant cells (HVT effect) and create an extremely inflammatory environment which incapacitates the tumor’s ability to evade the patient’s immune response.
Dr. Michael Har-Noy says that since the HVT response must be linked to a HVG rejection mechanism, the patient needs have an intact immune system that can rise up and reject the donor T-cells. Additionally, since graft rejection (HVG) is the desired response, the donor cells are also ideally intentionally mismatched to the recipient. Dr. Michael Har-Noy says that this is a vital and much-needed advancement over allogeneic BMT treatments, where only one third of potential recipients have a suitably matched donor.
The Mirror EffectTM, notes Dr. Michael Har-Noy, therefore involves the infusion of intentionally mismatched donor cells into a cancer patient that has received no pretreatment. The infused cells are then rejected by the patient’s immune system. This HVG rejection is the “mirror” of the deadly GVHD but has no toxicity. The HVG mechanism precipitates host-mediated tumor destruction (HVT), which is the “mirror” of the GVT process. Dr. Michael Har-Noy concludes that the Mirror EffectTM imitates the desired GVT effect of an allogeneic BMT while simultaneously avoiding the often-fatal toxicity of GVHD.
Dr. Michael Har-Noy feels that the Mirror EffectTM may be the beginning an entire new field of oncology. Please visit www.immunocare.net for more information on Dr. Michael Har-noy’s ongoing clinical trials.
Conventional cancer therapies, such as chemotherapy, surgery, and radiation, cannot target and destroy every metastatic cancer cell in a patient’s body. Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd, a biotech company in Israel, says that a patient’s natural immunity, if conditioned properly, may be able to do this. Dr. Michael Har-Noy indicates that if one could somehow condition a patient’s immune response so that it could find and eradicate malignant cells, an actual complete cure of the disease may be possible.
Over the past several years, Dr. Michael Har-Noy has developed a proprietary treatment he has termed the “Mirror EffectTM. The Mirror EffectTM technology is unique in that it both empowers a patient’s immune response to target malignant cells and disrupts the tumor’s ability to evade this response. The creation of the Mirror EffectTM and the development of the drugs that utilize it have the capacity to create an entire new field of oncology. Dr. Michael Har-Noy goes on to say that patenting and marketing these therapies could be both tremendously beneficial to cancer patients and immensely profitable for a company.
Dr. Michael Har-Noy has been working with his patent lawyers to construct a portfolio that protects the immense scope, depth, and detail of the Mirror EffectTM and outlines its use to condition a patient’s immune system to fight some of the most refractory conditions described in the medical literature. Dr. Michael Har-Noy notes that the patent portfolio he is creating entails not only protection of his company’s drugs and synthesizing methods but also has the potential to spawn an entirely new industry based on manipulating the human immune response.
Ultimately, Dr. Michael Har-Noy’s patent portfolio will probably start a new field of oncologic therapy and radically alter the way malignancies are treated. Patent attorneys have compared potential impact of Dr. Michael Har-Noy’s portfolio to that of the double-clicking of a mouse on a user interface on a computer screen. This double-clicking technology formed the foundation of the multi-billion dollar internet advertising industry. Dr. Michael Har-Noy believes his new technology will introduce an entirely new field of oncology and forever change the way cancer is treated, and that his Mirror EffectTM idea will therefore prove to be of virtually limitless value.
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.
Dr. Michael Har-Noy, CEO of Immunovative Therapies, Ltd. says that the failure of hundreds of immunotherapy clinical studies to produce meaningful anti-tumor treatments calls for a re-evaluation of their underlying theories. For more than 200 years, scientists have successfully used vaccines to prevent many infectious diseases by inducing a humoral antibody response. Dr. Michael Har-Noy notes that researchers have attempted to apply the same ideas in developing vaccines to treat existing cancers, despite the fact that vaccines giving protection against pathogenic infections cannot eradicate existing infections caused by the same pathogen. Therefore, notes Dr. Michael Har-Noy, the modeling of these cancer therapies is fundamentally flawed, because protective immunity does not provide therapeutic immunity.
Dr. Michael Har-Noy indicates that a specific cellular immune response is required to provide therapeutic immunity from cancer. Researchers have followed conventional strategies in cancer vaccine creation by attempting to find unique tumor-specific antigens (TSA) not found on normal cells, or by looking for tumor-associated antigens (TAA) overexpressed by malignant cells. Dr. Michael Har-Noy says that TSAs have only been found in cancers caused by infectious agents, such as EBNA-1 antigen from Epstein Barr virus-induced Burkitt’s lymphoma. However, TAAs have been identified in most cancers forming in immunocompetent patients. Furthermore, says Dr. Michael Har-Noy, many malignancies have a significant inflammatory component which includes a widely varied leukocyte infiltrate of neutrophils, macrophages, mast cells, and eosinophils, frequently associated with lymphocytes. Human cancers are usually densely infiltrated with immune cells – a fact arguing against inadequate tumor antigen recognition.
Dr. Michael Har-Noy notes that previous attempts to enhance patients’ immune responses have accelerated rather than slowed tumor growth. Therefore, he says, the notion that cancers are “invisible” to the immune system, which thus needs to be augmented, is misconceived. Dr. Michael Har-Noy thinks that the problem is that the patient’s immune response to the tumor, while strong, may be the wrong kind. It is therefore not surprising that tumor growth may be enhanced rather than suppressed by attempting to strengthen an immune response that has already failed to protect against cancer growth. Dr. Michael Har-Noy notes that this misconception is the basic flaw in the conventional strategy of cancer vaccine research.
Dr. Michael Har-Noy is conducting a Phase I/II trial of his CRCL vaccine in Bangkok, Thailand. Please visit www.immunocare.net for more information.