DermaVir Patch

Genetic Immunity's proprietary DermaVir Patch is a topically administered HIV Nanomedicine candidate designed to amplify the immune system to specifically kill HIV-infected cells. In GIHU-004, a Phase I study it showed excellent safety, tolerability, and immunogenicity: DermaVir evoked long-lasting gag-specific T cells 6- to 18,000 fold above pre-treatment values in all treated patients, in dose dependent manner.

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 Patch		Existing HIV/AIDS Therapy

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 Patch 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 Patch, 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 Patch. 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.