DermaVir

DermaVir - HIV-specific Immune Therapy Portfolio

DermaVir is designed to boost immune responses that can kill HIV-infected cells in HIV-positive or AIDS patients whose immune systems have been compromised by the virus. Since antiretroviral drugs cannot kill cells in the reservoirs or provide a cure we believe that DermaVir has the potential to be new State of Art treatment for HIV/AIDS.

DermaVir features all key technological elements of our Immune Therapy Technology Platform and represents a model for our rational vaccine design approach. The API of DermaVir is a single pDNA immunogen safely expressing 15 HIV antigens, the broadest antigen repertoire seen among HIV vaccine candidates to date. DermaVir Product is a "pathogen-like" nanomedicine and it is administered topically with our medical device, DermaPrep. All steps of DermaVir's novel mechanism of action have been consistently demonstrated in vitro, in animal models (mice, rabbits, primates) and human subjects.

We demonstrated that DermaVir exhibits its specific pharmacologic effects by intensifying the patient's own immune system to kill HIV-infected cells. Our clinical trials with DermaVir in ~70 HIV-infected patients demonstrated an excellent safety and tolerability in all doses. We found the optimal DermaVir dose for boosting HIV-specific T cell immune responses and demonstrated killing of HIV-infected cells by showing a statistically significant reduction of HIV-RNA in DermaVir treated patients compared to Placebo.

A comparison of DermaVir to existing treatment methods:

DermaVir		Existing HIV/AIDS Therapy

Mechanism		Mechanism
Boost immune system to kill HIV-infected cells Reconstitutes HIV-specific immunity Potential for remission Immune intensification might reduce HIV reservoirs		Interrupts viral life cycle Cannot reconstitute HIV-specific immunity No remission or cure even with treatment intensification Does not affect HIV-reservoirs
Toxicity Profile		Toxicity Profile
No dose-limiting toxicities		Toxicities limit optimal dosing and certain combination regimens
Resistance		Resistance
Immunologic resistance different from drug resistance		Combination of at least 3 drugs based on rapid resistance
Treatment Schedule		Treatment Schedule
4 x per year or less		1 x daily or more

The discovery leading to DermaVir began with our clinical observation and the extensive investigation of one HIV-infected subject. This patient demonstrated for the first time that boosting of HIV-specific cellular immunity with short interruptions of antiretroviral drug therapy leads to long-term immune control, referred to today as remission or "functional cure"(Lisziewicz et al New England Journal of Medicine 1999). Later we confirmed and extended this observation demonstrating that immune control can be induced with controlled rebound of the wild type virus during primary infection (Lori et al. Science 2000). These results suggested that expressing HIV antigens in dendritic cells boosts therapeutically effective T cell responses and provided the rationale and objectives for the development of DermaVir. Based on this rationale and the experimental data collected up to date with DermaVir immune intensification therapy we believe that boosting HIV-specific cellular immunity of the patients could control virus replication and lead to a "functional cure" by killing HIV infected cells and decreasing the reservoirs.