Juvaris BioTherapeutics Announces Publication of Preclinical Anti-Leukemic Effects of JVRS-100 Immunotherapy
JVRS-100 Immunotherapy Trial Currently Enrolling Patients
Burlingame, CA - September 30, 2010
Juvaris BioTherapeutics, Inc. today announced that results from preclinical studies using its lead compound, JVRS-100, as an immunotherapy to treat acute myelogenous leukemia (AML) were published in the September edition of the journal Cancer Biology & Therapy. JVRS-100 has been shown to induce significant innate immunity resulting in anti-viral, anti-bacterial and anti-cancer effects. A Phase 1 clinical trial of JVRS-100 is currently enrolling subjects at the Penn State Hershey Cancer Institute under the direction of Dr. David Claxton, Professor of Medicine.
The published data suggest a lasting anti-leukemic benefit from JVRS-100 as measured by survival prolongation consistent with induction of immunological memory. In these murine studies, initial treatment of leukemia with JVRS-100 resulted in increased survival even upon subsequent challenge after treatment concluded. This survival benefit is consistent with persistence of cellular effectors associated with the development of antigen-specific responses.
"The published studies demonstrate the therapeutic efficacy of JVRS-100 in multiple experimental leukemias and are consistent with a stimulation of a lasting TH1 anti-leukemic immune response, which is what we hope to demonstrate in the ongoing clinical study" said Grant Pickering, President and CEO of Juvaris. "Following leukemic challenge, administration of JVRS-100 was shown to arrest tumor cell growth in vivo and extend survival, occasionally resulting in complete elimination of tumor cells."
The Phase 1 clinical study is a single-center, open-label, dose escalation study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of JVRS-100 in patients with relapsed or refractory leukemia. The study is currently open to enrollment.
AML is a major unmet medical need with an overall survival rate of 14 percent. More than 10,000 new cases of AML are diagnosed annually in the United States, and approximately 7,500 patients succumb to the disease each year.
Juvaris BioTherapeutics is a clinical stage company developing adjuvanted vaccines to treat infectious diseases. The Company's lead adjuvant, JVRS-100, is a cationic lipid-DNA complex that is being developed as an adjuvant to improve the effectiveness of existing vaccines and to develop new vaccines against a variety of infectious diseases. Research indicates that the mechanism of action of JVRS-100 is distinct from other known adjuvants. The adjuvant complex self-assembles with disease-specific antigens and induces substantial antibody- and cell-mediated immune responses, particularly induction of CD4+ and CD8+ T lymphocytes. Significant immunological responses have been elicited by JVRS-100 in both prophylactic and therapeutic vaccine settings in multiple species. This platform provides the opportunity to develop many disease-specific immunotherapy products for which there are significant unmet medical needs. Juvaris is also developing JVRS-100 as a component of novel, proprietary vaccines against a variety of infectious diseases. For more information about the Company and its technology, please visit www.juvaris.com.
Grant E. Pickering