Juvaris BioTherapeutics, Inc., a biotechnology company developing therapeutics and adjuvanted vaccines for infectious diseases and cancer, announced the initiation of a phase I clinical trial of its lead compound, JVRS-100.

The trial will compare the safety, tolerability and immunogenicity of the JVRS-100 adjuvant co-administered with a commercial influenza vaccine compared to vaccine alone.

"JVRS-100 has demonstrated the ability to significantly increase immune responses of existing vaccines in preclinical studies, providing a potential opportunity to improve influenza vaccine efficacy," said Grant E Pickering, president and CEO of Juvaris. "This double blind trial will evaluate varying dose amounts of JVRS-100 and is designed to provide safety information, dose determination and the primary immunological response data used to determine efficacy for adjuvanted vaccines. While one influenza vaccine will be used in the study, we believe the results will inform about the broad applicability of JVRS-100 for use with many available vaccines".

Seasonal influenza affects approximately one billion people worldwide each year and results in five million severe illnesses and 500,000 deaths. Approximately 90 per cent of the deaths occur in the elderly. Seasonal influenza vaccines, which are widely used in the US and developed countries, have modest effectiveness in children and young adults, but are effective in only 30 per cent of the elderly population. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines in order to improve efficacy and reduce vaccine dosage requirements due to supply constraints.

"There is a great need to improve upon the efficacy of influenza vaccines particularly given their ineffectiveness in the elderly, who stand to benefit the most from vaccination, but unfortunately receive the least amount of protection," said Eric A Sheldon, MD, medical director and director of vaccine development at Miami Research Associates and an investigator for the Juvaris trial. "The JVRS-100 adjuvant has demonstrated promising preclinical activity and we look forward to evaluating this candidate in a randomized phase I trial". 0

The randomized, double blind, controlled phase I trial is expected to enrol 128 healthy subjects in four treatment cohorts. The study will evaluate a licensed trivalent, inactivated, split influenza vaccine with ascending dose levels of JVRS-100 compared to the vaccine alone. JVRS-100 will also be studied with reduced doses of the influenza vaccine to assess its effectiveness and vaccine dose-sparing effects. Primary objectives of the study are to assess the safety and tolerability of the JVRS-100 adjuvant and its ability to enhance immune responses to the influenza vaccine.

JVRS-100 is a toll-like receptor-directed cationic lipid-DNA complex that is being developed as a therapeutic and an adjuvant to treat multiple diseases.