NEW YORK, NY--(Marketwire - Oct 11, 2012) - Immunovative, Inc. ("IMUN" or the "Company") (OTCBB: IMUN) has today announced that Immunovative Therapies, Ltd. ("ITL") has been granted a U.S. Patent entitled "METHOD FOR ALLOGENEIC CELL THERAPY," which was issued September 25, 2012, under Patent No. 8,273,377. Foreign versions of this patent are pending around the world. This patent covers the proprietary method that utilizes immune cells from a normal donor to elicit an anti-tumor mechanism that mimics the Graft vs. Tumor (GVT) effect of non-myeloablative allogeneic stem cell transplants ("Mini-Transplant") without the toxicity of Graft vs. Host Disease (GVHD). Harnessing the power of the immune system to treat cancer and infectious disease has long been the goal of physicians and scientists. Unfortunately, cancer vaccines and cell immunotherapy methods have had difficulties in translating the promise of immune control into effect treatments. The most effective anti-cancer mechanism ever discovered is the GVT immune response that occurs after Mini-Transplant procedures. This mechanism can completely destroy chemotherapy-resistant metastatic cancers. Unfortunately, the clinical use of the GVT effect is severely limited due to extreme toxicity of an intimately related GVHD effect. Mini-Transplants are thus only widely used in advanced cases of leukemia, even though the GVT effect has been shown capable of killing many types of solid tumors. The separation of the beneficial GVT effect from the devastating GVHD toxicity has long been the goal of stem cell transplant scientists and is the subject of extensive research around the world.
ITL is believed to be the first to develop an immunotherapy drug product (AlloStim™) which enables the harnessing of the power of the GVT mechanism without GVHD side effects. ITL calls the mechanism which enables immune-mediated tumor destruction without GVHD toxicity the "Mirror Effect™." The "Mirror Effect™" mechanism represents a major breakthrough for treatment of cancer and infectious disease. Early human clinical trials have produced evidence of this technology's capability to stimulate the immune systems of heavily pre-treated metastatic cancer patients to kill widely disseminated metastatic cancers. A potentially pivotal, double-blind, placebo-controlled Phase II/III clinical trial in metastatic breast cancer is being prepared to document these effects in a controlled setting and determine if the immune-mediated tumor debulking provides patients with a survival advantage. This issued US Patent covers the use of intentionally mismatched, activated immune cells for treatment of cancer and infectious diseases. The patent discloses the concepts and methods related to ITL's proprietary "Mirror Effect™" technology and describes its lead immunotherapy drug candidate "AlloStim™." This patent also describes how AlloStim™ eliminates the need for a matched tissue donor and chemotherapy pre-conditioning for patients that require a bone marrow or stem cell transplant.
The newly issued patent is part of an intellectual property portfolio from ITL that includes 11 issued patents and numerous patent applications, to which IMUN has exclusive rights in the US and the rest of the world. The licensed patents cover compositions, methods of production, formulation, distribution and uses for treatment of all types of cancer and infectious diseases.
Seth M. Shaw, CEO of IMUN, stated: "The separation of the beneficial GVT effect from the devastating GVHD toxicity has been called the 'Holy Grail' of transplant research. ITL is the first to accomplish this significant scientific milestone. We are confident that ITL's extensive Intellectual Property ("IP") portfolio will provide our products with long-term market exclusivity. This patent is an important component of our growing IP estate, as the allowed claim language is very broad. We are now the exclusive allogeneic cell therapy company in the world. Our strong patent portfolio will now allow us to pursue opportunities for partnering and sub-licensing by indication and territory around the world."
Dr. Michael Har-Noy, CEO, founder of ITL and inventor of the "Mirror Effect™" technology stated: "Our patent portfolio is a valuable asset as it not only protects our AlloStim™ and AlloVax™ product candidates, but also provides protection of the unique mechanism of action that enables these products to have such powerful potential to debulk treatment-resistant metastatic disease. We are continuing to invest in research activities to improve our current product candidates and develop new products and further expand our patent portfolio. With protection of the novel mechanism of action, ITL and IMUN have the basis for development of a new industry based on powerful, non-toxic immunotherapy products that can work where all current treatment options have failed."
About Immunovative, Inc.:
On December 12th, 2011, Immunovative, Inc. ("IMUN") signed an exclusive License Agreement (the "License Agreement") with Immunovative Therapies, Ltd. ("ITL"). Under the terms of the License Agreement, IMUN has been granted an exclusive, worldwide license to commercialize any products covered under ITL's current issued and pending patent application portfolio, as well as the rights to any future patent applications, including improvements or modifications to the existing applications and any corresponding improvements or new versions of the existing products. Please visit IMUN's website at www.imun.com.
About Immunovative Therapies, Ltd.:
Immunovative Therapies, Ltd. is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israeli Office of the Chief Scientist. ITL is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israeli technological incubator program. The company was the Misgav Venture Accelerator's candidate for the prize for the outstanding incubator project of 2006, awarded by the Office of the Chief Scientist. ITL specializes in the development of novel immunotherapy drug products that incorporate living immune cells as the active ingredients for treatment of cancer and infectious disease. Please visit ITL's website at: www.immunovative.co.il
Forward-Looking Statements: Except for statements of historical fact, this news release contains certain "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, including, without limitation, expectations, beliefs, plans and objectives regarding the development, use and marketability of products. Such forward-looking statements are based on present circumstances and on IMUN's predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, and are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to fund operations and other factors over which IMUN has little or no control. Such forward-looking statements are made only as of the date of this release, and IMUN assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. Risks, uncertainties and other factors are discussed in documents filed from time to time by IMUN with the Securities and Exchange Commission.