Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines for infectious diseases, announced that it has begun enrolling patients in a Phase 2 clinical trial of its lead compound, JVRS-100, as an adjuvant for seasonal influenza vaccines in the elderly population.

"There is a significant need to improve the efficacy of seasonal influenza vaccines for elderly individuals given that current vaccines are effective in only a fraction of this population," said Tom Monath, M.D., acting Chief Medical Officer of Juvaris. "Results from our first clinical trial demonstrated that JVRS-100 enhances both antibody and T-cell mediated immune responses and thus holds potential for the development of improved influenza protection, especially in a population more susceptible to complications from influenza infection. Moreover, this was the first time an adjuvant has shown the ability to induce CD8+ cytotoxic T-cells in humans. This finding has broad implications for development of new vaccines against infectious diseases and cancer."

The randomized, double-blind, controlled trial will enroll approximately 472 subjects 65 years and older and compare antibody and T-cell responses to trivalent inactivated influenza vaccine administered with and without the JVRS-100 adjuvant. Primary objectives of the study are to assess its safety, tolerability and ability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine. The study is also intended to define the most effective dose of the JVRS-100 adjuvant and will evaluate three different doses. Enrollment will take place at six centers across the United States.

"Developing an adjuvanted influenza vaccine to confer superior immunity and ultimately better protection from disease is a critical objective, and this Phase 2 trial in the elderly will yield proof-of-concept for JVRS-100 in this underserved patient population," said Grant Pickering, President and Chief Executive Officer of Juvaris. "We look forward to the advancement of this trial, which is targeted to complete in mid-2010."

Seasonal influenza affects approximately one billion people worldwide each year resulting in 5 million severe illnesses and 500,000 deaths. Approximately 90 percent of deaths occur in the elderly. Seasonal influenza vaccines, which are widely used in the U.S. and developed countries, are generally effective in children and young adults, but are effective in only 30-50 percent of the elderly population. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines in order to improve efficacy and reduce vaccine dosage requirements.

About JVRS-100

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 BioTherapeutics

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