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Immunovative, Inc. Announces Issuance of A Key Patent in Japan
By: Marketwired .
Dec. 28, 2012 11:46 AM
NEW YORK, NY -- (Marketwire) -- 12/28/12 -- Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) has today announced that Immunovative Therapies, Ltd. ("ITL") has been granted a Japanese patent (Japanese patent no. 5144250) which issued on November 30, 2012. This Japanese patent is derived from a U.S. patent application that issued into U.S. patent no. 7,402,431. This U.S. patent is titled "T-Cell Therapy Formulation." The Japanese patent has patent claims related to our lead AlloStim product candidate as a composition of matter and also includes method claims for preparing the AlloStim composition. AlloStim has been cleared for testing in a randomized, placebo-controlled Phase II/III clinical study in patients with advanced metastatic breast cancer. This trial is currently being prepared for launch on or about April 2013 at the National Cancer Institute of Thailand. The primary end-point of the study is overall survival. The study will be conducted under strict international standards for Good Clinical Practices (GCP). If the study determines that AlloStim provides a survival benefit for these women suffering from metastatic breast cancer that is refractory to current treatment options, ITL plans to submit the data to regulatory authorities in the US and EU in support of licensing applications. ITL now has 13 patents issued in the United States, one patent in-licensed from the University of Arizona. This Japanese patent is the second international patent to issue.
Seth Shaw, CEO of IMUN, stated: "The issuance of our first patent application in Japan is the result of our investment in an intellectual property strategy to protect AlloStim in key jurisdictions around the world. Japan represents a major market opportunity for AlloStim. The Japanese have traditionally been resistant to embrace the current highly toxic therapies, such as chemotherapy. If AlloStim can be proven effective in the Thailand Phase II/III study with minimal side-effects, it is expected that there will be a great demand for this type of therapy in Japan. AlloStim, which contains living immune cells from normal blood donors, is considered to be more natural than the harsh chemical therapies and thus more suitable to the Japanese market. This patent and the several additional patents which remain pending in Japan and the rest of the world will enable us to seek licensing partners in these jurisdictions to assist us in bringing AlloStim to the market."
Dr. Michael Har-Noy, founder and CEO of ITL, stated: "Japan is a world leader in innovation of living cell therapy products. The ability to win such broad claims in such an active market, including composition of matter claims, considered the strongest type of patent protection in the pharmaceutical field, provides further confirmation of the novelty of our AlloStim product candidate."
AlloStim is a living cell immunotherapy product that is designed to elicit our proprietary anti-cancer mechanism called the "Mirror Effect." The Mirror Effect enables the stimulation of the same powerful anti-tumor mechanism of allogeneic stem cell and bone marrow transplant procedures, called the graft vs. tumor (GVT) effect, without the toxic side-effect called graft vs. host disease (GVHD). The GVT mechanism has been described as the most powerful anti-tumor mechanism ever discovered because it is capable of killing chemotherapy-resistant metastatic tumors. The clinical application of GVT is limited to certain type of blood cancers due to GVHD toxicity. The Mirror Effect is the first to break the limitations of allogeneic stem cell/bone marrow transplants because it is the first mechanism to be discovered that enables the GVT effect without GVHD toxicity. AlloStim is designed to elicit the Mirror Effect in cancer patients by stimulating the patient's own immune system to eliminate tumor cells wherever they reside in the body.
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