MCLEAN, Va., and BUDAPEST, Hungary, Feb. 11 GeneticImmunity, a US/Hungarian clinical-stage biopharmaceutical company focusing onthe development of its patented immunotherapeutic platform technology,announced clinical safety and immunogenicity data on its DermaVir Patch, atopically administered HIV immune therapy. The presentation, titled, "SingleDermaVir Patch Treatment of HIV+ Individuals Induces Long Lasting, HighMagnitude and Broad HIV-Specific T Cell Responses," was given at the 15thAnnual Conference on Retroviruses and Opportunistic Infections (CROI) inBoston, February 3-6, 2008.
Presently available antiretroviral drugs interfere with the viral lifecycle, but because of their toxicity and resistance profiles are typicallyprescribed as late as possible in the disease progression. Recent findingswith DermaVir Patch treatment suggest that this innovative medicine inducesnew HIV specific immune responses in HIV infected patients not achievable byantiretroviral drugs. Such an alternative treatment approach has thecapability to address the needs of those HIV positive individuals who have notyet begun drug therapy as well as those who are currently on drug therapy.
Genetic Immunity studied nine HIV infected individuals on fullysuppressive antiretroviral therapy who were treated a single time with either0.1, 0.4 or 0.8 mg of multiple HIV antigens encoding plasmid DNA, the activesubstance in DermaVir Patch. The same antiretroviral drug regimen wascontinued during the one-year follow-up.
HIV-specific T cell Precursors with High Proliferative Capacity (PHPC)were quantified via an assay performed by Franco Lori, M.D. and hiscollaborators. The DermaVir Patch treatment resulted in significant inductionof PHPC counts in all nine patients in the study. Importantly, theseprecursor T cell responses were long lasting, 10-100 fold increased PHPCcounts over baseline were detected during the one year follow up. Anindependent study has demonstrated that PHPC count inversely correlates withviral load.
Safety was assessed with standard clinical and laboratory evaluations, anddermatological analysis of skin reaction. DermaVir Patch continued to show alack of dose limiting toxicities. Through multiple studies, the only sideeffect seen so far has been limited to transient erythema (redness of theskin).
Julianna Lisziewicz, Ph.D., Co-Founder and CEO of Genetic Immunity, said,"The distinctive safety and immunogenicity data is consistent with our primatestudies showing viral load reduction associated with immune responses inducedby DermaVir Patch treatment. The Genetic Immunity team is encouraged by thisdata, which suggests that the DermaVir Patch is on its way to becoming thefirst immune therapy for HIV-infected individuals."
Franco Lori, M.D., CEO of Virostatics said, "In an independent experiment,we demonstrated that high PHPC counts significantly correlate with low viralload. The clinical results of the DermaVir Patch suggest a novelimmunogenicity profile. We are hopeful that many patients may see benefitfrom this truly innovative antiviral therapy."
About Genetic Immunity(R)
Genetic Immunity is a US/Hungarian development stage company establishingleadership in next-generation biopharmaceuticals. The Company is leveragingits proprietary platform technology to create new markets for infectiousdiseases, cancer and allergy through the discovery, development andcommercialization of topically administered immune therapies. Theseindications represent significant unmet medical need and potential foralternative treatment approaches. Genetic Immunity's lead product, theDermaVir Patch for the treatment of HIV/AIDS, was discovered by the Company'sfounders, and is in Phase II clinical development with the opportunity to bethe first immune therapy approved for HIV-infected individuals.
About DermaVir Patch