NEW YORK, NY--(Marketwire - December 28, 2012) -
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.
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.