NEW YORK, NY -- (Marketwire) -- 11/13/12 -- Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) has today announced that Immunovative Therapies, Ltd. ("ITL") and The University of Arizona Cancer Center (UACC) and The University of Arizona Medical Center (UAMC) (University Campus and Diamond Children's) have agreed to expand their current collaboration to include investigator-initiated clinical trials using AlloStim and AlloVax, with an initial focus on adult and pediatric leukemias and childhood cancers that are refractory to standard treatments. Emmanuel Katsanis, MD, Professor of Pediatrics, Director of the Blood and Marrow Transplant Program at UACC, Section Head of Pediatric Hematology/Oncology, the Louise Thomas Endowed Chair in Pediatric Cancer Research at the Steele Children's Research Center ("Steele Center") and the recently appointed ITL Chairman of the Scientific Advisory Board and Chief Medical Officer, stated: "As a pediatric oncologist that must deal with the heartbreak of relapsed leukemia and refractory childhood cancers on a daily basis, I am extremely excited about the expansion of the UACC/UAMC/Steele Center collaboration with ITL to include investigator-initiated trials that could potentially provide novel experimental treatment options for our patients. We hope to build upon our preclinical published studies and ITL's initial promising clinical data using AlloStim in heavily pre-treated, high disease-burdened adult metastatic disease patients to learn whether we can apply this technology to leukemia and to children with refractory cancers."
Investigator-initiated protocols are being developed for submission to the FDA and local IRB regulators. Dr. Andrew Yeager, MD, Professor of Medicine, and Dr. Yi Zeng, MD, PhD, Assistant Professor of Pediatrics, will serve as the initial Principal Investigators of the proposed leukemia clinical trials and Dr. Lisa Kopp, DO, Assistant Professor of Pediatrics, will be the Principal Investigator of the Pediatric Solid Tumor phase I/II trial. Nicolas Larmonier, PhD, Associate Professor of Pediatrics and Immunobiology, will head efforts to conduct immunological monitoring and continued research on the mechanism of action of this therapy in humans.
ITL and the University of Arizona ("UA") have had a collaborative relationship since 2009 when ITL licensed from UA the exclusive rights to the patented individualized therapeutic cancer vaccine called Chaperone-Rich Cell Lysate ("CRCL"). CRCL was invented by Dr. Katsanis and his colleagues at the UA Steele Children's Research Center. CRCL combined with AlloStim is called AlloVax. Under this collaboration, ITL transferred technology to Dr. Katsanis' laboratory for the production of a mouse version of AlloStim. Dr. Katsanis' laboratory has subsequently conducted a series of experiments to study the mechanism of action of AlloStim and the effects of AlloStim when combined with CRCL to produce AlloVax. In a recent publication in the peer-reviewed journal Blood(1), Dr. Katsanis and his team reported that the AlloVax combination of CRCL with AlloStim provides a potent anti-tumor effect that is more effective than either drug administered alone. In addition, AlloStim was shown to impair the ability of tumors to suppress the immune system and evade immune destruction. Dr. Katsanis' laboratory also has conducted pre-clinical toxicology studies on AlloStim, AlloVax and CRCL in support of regulatory submissions to the FDA.
Jerry Zillman, Co-Founder and President of the Tee up for Tots Foundation (http://www.teeupfortots.org/index.php), stated: "Our Foundation is dedicated to raising funds in support of world-class researchers seeking cures for childhood cancers. We have been a long-time supporter of Dr. Katsanis and the Steele Children's Research Center at the University of Arizona. We are pleased to see, that in part through our efforts, a discovery we originally supported has been successfully translated into a product ready for clinical trials in children. We are also proud to make a financial pledge to support these proposed clinical trials."
Seth Shaw, CEO of IMUN, stated: "We are very proud welcome the University of Arizona to our list of university-based clinical collaborators. We are especially encouraged by the fact that the world-class scientists and cancer specialists at UACC/UAMC/Steele Center believe there is potential for our experimental drug products to provide a future treatment option for children suffering from cancers for which no treatments options currently exist. We are also proud to join the Tee up for Tots Foundation in supporting this pediatric cancer research. This support is dedicated to the memory of Mr. Zillman's daughter, Courtney, who was taken at the tender age of 4 years after a brave battle with neuroblastoma, which is a devastating childhood cancer."
Dr. Michael Har-Noy, CEO and Founder of ITL, stated: "Since 2009, we have enjoyed an intellectually stimulating and highly productive collaboration with Dr. Katsanis, his colleagues and his dedicated and talented laboratory staff. We look forward with enthusiasm to both continue our ongoing collaborative research and to expand this collaboration to translate results to the clinic. Refractory leukemias and childhood cancers represent a large unmet medical need. We are hopeful that our immunotherapy drug candidates can be shown in the well-designed investigator-sponsored clinical trial at UACC/UAMC/Steele Center to be safe and effective in children. The planned clinical trials take advantage of a novel way to use our experimental drugs. We call this novel protocol design a 'Micro-Transplant.' This clinical design attempts to take advantage of the known anti-tumor effect of 'Mini-Transplant' procedures and the direct anti-tumor effects of AlloStim in such a manner predicted to preserve the powerful cancer killing effects and minimize side-effects. It is an honor to be collaborating with these professionals that have dedicated their lives to improving the lives of children suffering from cancer."
(1) Nona Janikashvili; Collin J LaCasse; Claire Larmonier; Malika Trad; Amanda Herrell; Sara Bustamante; Bernard Bonnotte; Michael Har-Noy; Nicolas Larmonier; Emmanuel Katsanis Allogeneic effector/memory Th-1 cells impair FoxP3+ regulatory T lymphocytes and synergize with chaperone-rich cell lysate vaccine to treat leukemia. Blood 2011;117(5):1555-64.
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.