Profectus BioSciences commences GENEVAX IL-12 phase 1 study for HIV

Profectus BioSciences, Inc., a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, and the AIDS Clinical Trials Group (ACTG) announced today the initiation of a phase 1 study of Profectus' multi-antigen HIV plasmid DNA (pDNA) vaccine administered with various doses of GENEVAX™ interleukin-12 (IL-12) pDNA adjuvant and delivered using the electroporation (EP) based TriGrid™delivery system (TriGrid) developed by Ichor Medical Systems. The multi-center study is being sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study is being conducted by the NIAID-funded ACTG under a protocol designated A5281.

The phase 1, placebo-controlled, dose-escalation study will enroll 60 HIV-infected subjects on stable anti-retroviral therapy. It will assess the safety and immunogenicity of a fixed dose of the Profectus therapeutic multi-antigen HIV pDNA vaccine administered with escalating doses of GENEVAX™ IL-12 pDNA adjuvant and delivered with the TriGrid device. Non-human primate studies conducted by Profectus have demonstrated that the combination of IL-12 pDNA adjuvant plus EP delivery significantly increases the immunogenicity of pDNA vaccines compared to delivery with either EP alone or IL-12 alone. In a separate clinical study (HVTN 080), a fixed dose level of GENEVAX™ IL-12 is currently being evaluated for its ability to augment immune responses to an experimental HIV pDNA vaccine delivered with EP in HIV-negative volunteers. As previously reported, the interim data from that study indicate GENEVAX™IL-12 significantly increased the percentage of vaccine recipients that mounted antigen-specific T-cell responses as compared to HIV pDNA alone. In addition to improving response rates, the inclusion of GENEVAX™ IL-12 was also observed to significantly lessen injection site discomfort.

Dr. John Eldridge, Profectus BioSciences' Chief Scientific Officer, said: "Profectus is very pleased to collaborate with the NIH and the ACTG in the development of a therapeutic vaccine with the potential to improve viral control and clinical outcome in subjects battling HIV infection. The recent clinical results that validate the adjuvant activity of GENEVAX™ IL-12 in normal healthy volunteers provide a level of confidence that a significant improvement in immunogenicity will be obtained relative to the therapeutic HIV vaccines tested to date."