Dr. Michael Har-Noy, founder and CEO of Immunotherapies, Ltd., says that in light of the unexpected positive results in patients that had exhausted all treatment options in a previous Phase I/II clinical trial, Immunovative Therpies, Ltd. has received full regulatory approval to advance AlloStimTM to a pivotal Phase II/III licensing trial. Dr. Michael Har-Noy notes that this will be a randomized, double-blind, placebo-controlled clinical trial in patients with advanced metastatic breast cancer. The patients will have been previously treated with a taxane, anthracycline and capecitabine. Her2+ patients will be pre-treated with a Herceptin-containing protocol. Dr. Michael Har-Noy goes on to say that a total of 208 patients will be recruited, with 104 receiving AlloStimTM and 104 receiving a placebo compound. The study will take approximately two years to complete enrollment. The trial will be conducted at the National Cancer Institute of Thailand. Dr. Michael Har-Noy says that the primary end-point will be overall survival (OS). Patients are treated with four intradermal AlloStimTM (or placebo) injections on days zero, four, seven, and ten. On day 14, all patients undergo a cryoablation procedure targeting one metastatic lesion and either AlloStimTM or placebo is then infused into the ablated lesion. On day 17, says Dr. Michael Har-Noy, AlloStimTM or placebo is again injected into the previously ablated lesion. On day 21, an intravenous infusion of AlloStimTM or placebo is again administered. Booster IV infusions of AlloStimTM or placebo are administered again on days 49, 77 and 105. Dr. Michael Har-Noy notes that the study is powered at 80% to detect a 50% or greater difference in OS between the arms at a significance level (alpha) of 0.05. Secondary end-points include Quality of Life and immunological response. If the overall survival in the treatment group is significantly longer than the placebo, says Dr. Michael Har-Noy, these data will be used to support US marketing application under rule 21 CFR 312.120. The data can also be used to support marketing applications in Canada, Japan and the EU.
Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., an Israeli biotechnology company, has developed a unique drug called AlloStimTM. This drug creates an immune tumor-killing response similar to that of a bone marrow transplant but without the deadly graft-vs-host side effect. AlloStimTM has key advantages over CAR-T (chimeric antigen receptor T-cell) therapy, which is being developed by companies such as Kite Pharma, Juno Therapeutics, and Novartis. First, says Dr. Michael Har-Noy, AlloStimTM can be mass produced and is not individualized to each patient’s tumor. CAR-T treatment, however, must be made using each patient’s own unique tumor cells, and is therefore not scaleable.
Dr. Michael Har-Noy notes that preliminary studies of AlloStimTM show that it works against most solid tumors, whereas CAR-T therapy seems to have limited efficacy against such lesions. Furthermore, CAR-T therapy can cause serious side effects, the worst of which is a cytokine release syndrome similar to septic shock. AlloStimTM, says Dr. Michael Har-Noy, causes no serious complications. The most common side effect of AlloStimTM is a flu-like syndrome which lasts a short period.
Dr. Michael Har-Noy is preparing to test AlloStimTM in a pivotal Phase III randomized trial involving patients with refractory metastatic colon cancer. Enrolled patients will be KRAS gene positive and will have exhausted all treatment options. For KRAS gene positive metastatic colon cancer patients, there is no real third-line treatment option. Dr. Michael Har-Noy says that if the preliminary trial results are positive, AlloStimTM may qualify for fast track FDA approval. Once approved for colon cancer, AlloStimTM can be tested in a variety of other indications.
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.