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Genetic Immunity Announces Data Related to the DermaVir Nanomedicine Patch in the Journal of Immunology

Data Supports Use of HIV-specific T cell Precursors with High Proliferative

Capacity (PHPC) Marker to Predict Reduction of Viral Load

MCLEAN, Va., and BUDAPEST, Hungary, April 21 /PRNewswire/ -- Genetic Immunity(R), a US/Hungarian clinical-stage company focused on patented nanomedicines for immune amplification, announced today that the Journal of Immunology published findings on a key biomarker currently being used in clinical studies of its lead HIV/AIDS nanomedicine candidate, the DermaVir Patch. The paper, entitled "HIV-1-Specific T-Cell Correlate with Low Viremia and High CD4 Counts in Untreated Individuals," highlights data from a study conducted by Sandra Calarota, Ph.D., of the Research Institute for Genetic and Human Therapy (RIGHT).

In Dr. Calarota's study of 32 HIV-1 infected individuals, high immunological responses measured by a novel assay of T cell Precursors with High Proliferative Capacity (PHPC assay) better correlated with viral suppression and positive immunologic outcomes, than did the traditional ELISPOT assay.

These data further validate and support results from a clinical study of Genetic Immunity's DermaVir Patch presented in February 2008 at the 15th Annual Conference on Retroviruses and Opportunistic Infections (CROI). The study demonstrated that the DermaVir Patch induced a significant increase of PHPC counts in all 9 HIV-1-infected participants, suggesting that the DermaVir Patch may promote a targeted amplification of the immune system capable of reducing the amount of circulating HIV virus.

Dr. Franco Lori, the lead author of the study said, "The correlation between high PHPC counts and low viral load in HIV-infected subjects suggests that the presence of a greater number of T-cells that have retained their ability to expand and function normally may be a better predictor of patient outcomes. This new PHPC assay may also be a valuable tool in the development and testing of urgently needed nanomedicines, immune therapies and prophylactic vaccines for a number of diseases in addition to HIV/AIDS."

Julianna Lisziewicz, Ph.D., Co-Founder and CEO of Genetic Immunity, said, "The design and testing of the DermaVir Patch has long focused on PHPCs as a marker. We see these results as validation that our approach has been scientifically sound.

About Genetic Immunity(R)

Genetic Immunity is a US/Hungarian development stage biopharmaceutical company establishing leadership in Nanomedicines for immunity amplification. next-generation biopharmaceuticals. Nanomedicine, an offshoot of nanotechnology, refers to highly specific medical intervention at the molecular scale for curing disease or repairing damaged tissues, such as bone, muscle, or nerve. The Company is leveraging its proprietary immune amplification platform technology, Genetic Immunity aims to create new markets for infectious diseases, cancer and allergies through the discovery, development and commercialization of topically administered nanomedicines. These indications represent a significant unmet medical need and the potential for alternative treatment approaches. Genetic Immunity's founders discovered the lead product nanomedicine candidate, the DermaVir Patch for the treatment of HIV/AIDS. The DermaVir Patch is in Phase II clinical development and could be the first nanomedicine immune therapy approved for HIV-infected individuals. DermaVir Patch has demonstrated excellent safety, immunogenicity and antiviral efficacy in preclinical studies. Phase I/II trials to date have confirmed safety and tolerability and indicate the induction of long-lasting HIV-specific T cells.

About the Nanomedicine Technology Platform

Genetic Immunity's immune amplification platform technology is used to develop nanomedicines comprised of two principal components: NanoComp and DermaPrep. NanoComp is a patented nanoformulation technology that includes disease-specific plasmid DNA encoded antigens. DermaPrep is the topical administration device that delivers NanoComp into a patient's lymph node dendritic cells to induce T cell mediated immune responses that can alleviate a broad spectrum of diseases. These two components together make up the DermaVir Patch. The plasmid DNA within DermaVir Patch's NanoComp nanoparticles is specific to HIV and topically delivered via DermaPrep to amplify the immune system to kill only HIV-infected cells.


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