Genetic Immunity Clinical Trial Data Published in PLoS ONE

DermaVir Immunization Boosted Long-Lasting Memory T-cell Responses in Every Patient

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 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).

Today, the National Institutes of Health (NIH) is sponsoring a clinical trial in 72 HIV-positive adolescents. Genetic Immunity plans to start a Phase IIB study on 120 HIV-positive adults and a Phase II study on Hepatitis C/HIV co-infected patients the later part of 2012. For more information on the Company, our products and our trials, please visit us on the web at: www.geneticimmunity.com.

Forward-Looking Statements

Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company's current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements.

For Further Information:

Conrad F. MirChairman/CEOGenetic Immunity Inc.+1.
973.798.8882conradfmir@geneticimmunity.com

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Posted: May 2012

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