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Collaboration With Penn State University Will
Focus on Immunotherapeutic Vaccine Development for AML Juvaris BioTherapeutics, Inc. announced today award of a one year Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) in collaboration with Dr. David Claxton at Penn State College of Medicine, Penn State University's medical school, for the development of a therapeutic vaccine approach for the treatment of acute myelogenous leukemia (AML). Juvaris' novel and potent vaccine technology will be tested in rodent tumor models to evaluate the impact on leukemia using an antigen-specific immunotherapeutic AML vaccine (JuvaVax). The SBIR grant application was supported by preclinical data generated by Juvaris and Dr. Claxton demonstrating significant protection in a rodent tumor model. "We are pleased to be working with the support of the NCI to develop a therapeutic vaccine for AML," said Martin D. Cleary, Co-founder, Chairman and CEO of Juvaris. "Over the years, our Company has generated considerable long-term survival data in dogs with naturally-occurring cancers. These data in conjunction with the AML tumor model results, strongly suggest our technology platform may be applicable to a variety of tumor types. We also believe the award of this cancer grant together with our previously announced infectious disease grants, demonstrates the robustness and broad applicability of the Juvaris BioTherapeutics technology," stated Mr. Cleary. AML represents 90% of all adult acute leukemias, with an estimated 10,600 new cases annually in the United States. The overall survival rate for AML is 14%, and approximately 7,400 patients succumb from this cancer every year. The majority of patients with AML move into remission after initial chemotherapy, however, current treatments are largely ineffective when relapse eventually occurs. Therefore, there is a critical need for more effective modalities to delay or prevent the recurrence of the cancer. About Juvaris Juvaris BioTherapeutics was created in 2003 to develop an immunotherapeutic product platform for the treatment of infectious diseases and cancers using lipid-DNA complexes. Cationic lipids are formulated with non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a lipid-DNA complex, which as a single product will have utility in multiple infectious disease and cancer applications. The JuvImmune product has been shown to be at least 50-times more potent at triggering innate immune activation and interferon release than current immune stimulants. When combined with disease-specific antigens, the technology creates JuvaVax vaccines capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes (CTL). Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic settings in a variety of mammals including rodents, rabbits, cats, dogs and non-human primates. Moreover, substantial immune responses have been induced following oral and intranasal administration. This platform provides the opportunity to develop many disease-specific immunotherapy products, for which there are significant unmet medical needs. In January 2006, the Company announced the award of a two-year Small Business Technology Transfer (STTR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH for the development of an influenza A virus vaccine. In March 2006, the Company announced the award of an 18-month Small Business Innovation Research-Advanced Technology (SBIR-AT) grant from NIAID for the development of an HIV vaccine, and in September 2006, the Company announced the award of a two-year biodefense SBIR grant from NIAID for the development of an immunotherapeutic treatment for Tularemia. The Company encourages investment and partnering inquiries, including this project, and can be reached at its website @ www.juvaris.com. Company Contact: |