MCLEAN, Va and BUDAPEST, Hungary, May 17, 2012 (GLOBE NEWSWIRE) -- Genetic Immunity Inc., a privately-held, biopharmaceutical company developing Langerhans cell-targeted immunotherapies, published its human proof-of-concept clinical trial, in PLoS ONE, a highly-regarded medical industry publication. The data demonstrated the induction of long-lasting memory T cell responses after a single immunization of DermaVir, the Company's lead vaccine candidate for patients infected with the human immunodeficiency virus (HIV). The publication is free to access in http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0035416.
"The results of our clinical trial confirmed our preclinical safety and immunogenicity data," said Genetic Immunity Founder, President & Chief Science Officer Julianna Lisziewicz, PhD. "These central memory T cell responses are associated with the protection from infectious diseases such as HIV, Hepatitis C and malaria. Our findings demonstrate that our Langerhans cell-targeted delivery system is suitable to induce broad and potent T cell immunity."
Regarding the result of the study, Denes Banhegyi, MD, the principal investigator of the study, added, "Decades of drug treatment can neither eliminate HIV-infected cells from the reservoirs nor reconstitute HIV-specific immunity. A broad epitope pool is key to long-term, non-progression. With a DermaVir immunization, patients can have hope that their daily drug burden could be lessened."
About the GIHU004 study:
The dose escalation study, labeled GIHU004, was conducted with three (3) topical DermaVir doses targeted to epidermal Langerhans cells to express fifteen (15) HIV antigens simultaneously in several draining lymph nodes. Antigen presentation in the lymph nodes is required to boost the immune system. Safety, tolerability and HIV-specific T cell responses against five (5) of the fifteen (15) DermaVir antigens were evaluated.
DermaVir-associated side effects were not dose-dependent and limited to mild, transient skin reactions. One of the more noteworthy results of the study was the dose-dependent expansion of HIV-specific central memory T cells with high proliferation capacity. The potent induction of Gag, Tat and Rev-specific memory T cells suggests that DermaVir boosts T cell responses specific to all 15 HIV antigens expressed from the single DNA. This is the first time that a vaccine induces memory T cell responses against all fifteen (15) antigens in human subjects.
About the DermaVir HIV Therapeutic Vaccine:
Today, HIV/AIDS is managed with life-long highly active antiretroviral therapy (HAART). This treatment, although widely accepted as the standard, raises concerns about adverse effects, resistance and the financial burden of treatment. A short fall of HAART is that it does not cure the disease because it does not kill infected cells in the latent reservoirs. Based upon our trials, DermaVir boosts and maintains killer T cells in HIV-infected human subjects. It has the broadest specificity in vaccine candidates that limits the development of resistance. Three (3) independent clinical trials, conducted in the USA and EU have consistently demonstrated the safety, immunogenicity and preliminary antiviral efficacy of DermaVir treatments.
About Genetic Immunity:
Genetic Immunity Inc., is a privately-held, U.S. biopharmaceutical company that has developed a proprietary Langerhans cell targeting delivery system which can induce long-lasting T cell immunity for therapeutic vaccinations against infectious diseases and cancer. Our proprietary system delivers a genetically targeted nanomedicine formulation that can simultaneously express 15 disease-specific antigens. All of our medicines are delivered topically using our CE-marked medical device, DermaPrep(TM).
Excerpt from:
Genetic Immunity Clinical Trial Data Published in PLoS ONE
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