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The University of Arizona Cancer Center (UACC) and the Steele Children’s Research Center have announced their collaboration with Immunovative Therapies, Ltd. (ITL) to begin clinical trials using AlloStim™ and AlloVax™, with an initial focus on adult and pediatric leukemias and childhood cancers.
The clinical trials will take place at The University of Arizona Medical Center – University Campus and Diamond Children’s.
Emmanuel Katsanis, MD, professor of pediatrics, director of the UACC Blood and Marrow Transplant Program, section head of pediatric hematology/oncology, said, "As a pediatric oncologist who must deal with the heartbreak of relapsed leukemia and childhood cancers on a daily basis, I am extremely excited about the expansion of the UACC/ Steele Center/ UAMC 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™."
Investigator-initiated protocols are being developed for submission to the FDA and local IRB regulators. Andrew Yeager, MD, professor of medicine, and Yi Zeng, MD, PhD, assistant professor of pediatrics, will serve as the initial principal investigators of the proposed leukemia clinical trials. 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 UA Steele Children’s Research Center have had a collaborative relationship since 2009 when ITL licensed from the university 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 Steele 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, 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.
Nov. 14, 2012