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

Currently in Phase II clinical trials, the DermaVir Patch is comprised of two patented components: NanoComp and DermaPrep. NanoComp is an antigen composition platform that combines a disease-specific plasmid DNA with the Company's formulation technology. The DermaVir Patch's unique DNA encodes the majority of HIV antigens into the NanoComp formulation to allow for a broad immune response. DermaPrep is a topical administration device for delivering the disease specific NanoComp formulation specifically into the dendritic cells.

DermaVir Patch Advantages vs. Existing Therapies

• Resistance
  In pre-clinical, non-human primate studies of the DermaVir Patch, no resistance was observed following repeated treatments. Although DermaVir Patch nanomedicine could theoretically lead to immune resistance, it does not overlap with drug resistance and DermaVir-resistant viruses are expected to respond to all antiretroviral drugs.
  
  
• Toxicity
  In pre-clinical and initial clinical studies DermaVir Patch demonstrated non-systemic toxicities, which were limited to local skin reactions. The nanomedicine candidate's unique risk/benefit profile differs from conventional drugs that require a careful balance of toxicity and efficacy during all development stages.
  
  
• Potential in multiple indications
  The DermaVir Patch is potentially effective as a monotherapy while current treatment regimens involve drug combinations, or "cocktails". Although drug-naïve individuals represent the initial target for DermaVir Patch, the ability to reconstitute HIV-specific immunity sets it apart from all other available treatments and opens the door for the use of DermaVir in combination with these treatments.
  
  
• Treatment Schedule
  DermaVir Patch's mechanism of action induces HIV-specific precursor T-cells with long half-lives, which translates to long-term efficacy that could allow for a significantly less frequent administration schedule relative to currently available drugs. Results from ongoing clinical trials suggest that DermaVir Patch could be dosed six times per year during three-hour treatment periods.

DermaVir Patch is Genetic Immunity's patented nanomedicine candidate with a novel mechanism of action that amplifies the immune system to specifically kill HIV-infected cells. DermaVir Patch originated from critical observations of the "Berlin Patient" made by Genetic Immunity's founders. Their extensive examination of this patient indicated that 1) long-term immune control of virus replication is feasible in an HIV-infected patient and 2) 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 the DermaVir Patch. The "Berlin Patient" experienced controlled viral load rebounds after receiving antiretroviral treatment followed by two interruptions in drug therapy. A blood test 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 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 these patients.