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sharing info about hiv functional cure
Apr 14, 2011

Thank you for taking your time to answer our concernes and questions. I would like to get your thoughts on this product created by "berlin patinet" DR. "Genetic Immunity's proprietary DermaVir is a topically administered HIV Nanomedicine candidate designed to amplify the immune system to specifically kill HIV-infected cells. Excellent safety, immunogenicity and antiviral efficacy has been observed 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 with viral load reduction observed in Phase II. DermaVir has provided human proof-of-concept for the Vaccine Development Platform in one of the most difficult areas of modern medicine, HIV/AIDS.

It is a potential first-in-class antiviral Nanomedicine designed to inhibit viral replication by cytotoxic killing of HIV-infected cells. Currently, there is no approved immune amplification Nanomedicine on the market to treat HIV/AIDS.

A comparison of DermaVir to existing treatment methods:

DermaVir Existing HIV/AIDS Therapy

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Mechanism Mechanism Amplifies immune system to kill HIV-infected cells Reconstitutes HIV-specific immunity Interrupts viral life cycle (antiretroviral drugs) Cannot reconstitute HIV-specific immunity

Toxicity Profile Toxicity Profile No dose-limiting toxicities indicated Potential use in combination with existing therapy Toxicities limit optimal dosing and certain combination regimens

Resistance Resistance No established immunologic resistance Immunologic resistance different from drug resistance Major limitation for long-term use Combination of 3+ drugs based on rapid resistance

Treatment Schedule Treatment Schedule 6 x per year or less 1 x daily or more

DermaVir consits of two patented components: Nanomedicine and DermaPrep and is currently in Phase II clinical trials. Nanomedicine is a platform combining a disease-specific plasmid DNA and Genetic Immunity's proprietary formulation technology. The unique DNA encodes the majority of HIV antigens and is formulated to Nanomedicine to induce a broad specific immune response. DermaPrep is our topical administration device for targeted delivery of disease specific Nanomedicine formulation to the dendritic cells.

The methodology behind all of Genetic Immunity's product candidates, including the DermaVir, originate from clinical observations made by Company's founders of the "Berlin Patient", an HIV infected individual whose immune system learned to control the infection. Their extensive examination of this patient indicated that a: long-term immune control of virus replication is feasible in an HIV-infected patient and b: antiviral T cells can control HIV replication in HIV-positive individuals (Lisziewicz et al. New England Journal of Medicine, 1999).

About the "Berlin Patient" The "Berlin Patient" observation and subsequent primate studies (Lori et al., Science 2000) and clinical trials (Rosenberg et al., Nature 2000) provided the rationale for Genetic Immunity's DermaVir. The "Berlin Patient" experienced controlled viral load rebounds after receiving antiretroviral treatment followed by two interruptions in drug therapy. Blood tests taken in 1996 showed that this patient developed HIV-specific precursor T-cell responses that could control virus replication. Despite permanent interruption of therapy, the "Berlin Patient's" viral load has not rebounded because his immune system has continued to control viral replication and the disease to this day. This patient demonstrated the feasibility of long-term immune control of virus replication in an HIV-infected individual and showed that antiviral T cells are capable of controlling HIV replication in patients.

Response from Dr. Henry

It is an interesting product and concept but way too early to tell if hypothetical benefit translates into affordable clinically meaningful benefit and long term safety. KH



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