About HIV

DermaVir Patch Market Opportunity
Up to an estimated 78% of patients are failing to respond to antiretroviral drugs, according to HIV Drug Development-Emerging Technologies (Frost & Sullivan Research, 2006). Genetic Immunity's nanomedicine immune amplification therapy has the potential to treat HIV in treatment naďve patients infected with HIV without compromising future therapeutic options.

Lead Indication: Sub-Type B (Clade-B)
The DermaVir Patch is based on HIV Clade "B," which represents the majority of HIV circulating major marketplaces, including North America and Western Europe. Genetic Immunity estimates that DermaVir Patch could initially be used to treat approximately 10% of the HIV-infected, drug-naïve patients in the U.S. and Europe. Considering the level of resistance among drug-naïve patients, however, there is considerable opportunity for upside to this estimate. An 8% hike in resistance among drug-naïve patients was recorded in 1999 and today has risen to an alarming 20%. If this trend continues, then HIV-infected patients who graduate to traditional drug therapy may become less likely to reach desired viral load reduction to undetectable levels.

Line Extension by Sub-Type
Subtype-optimized DermaVir is more effective against the matching virus. In addition to the lead DermaVir Patch sub-optimized for Clade "B," Genetic Immunity is developing two additional subtype-optimized DermaVir Patch product candidates based on CRF B/A and Clade "C," which reflect HIV strains encountered in emerging markets (e.g., Africa, India, China and Russia). The product candidate sub-optimized for Clade "C" will also be used for the pediatric patient population.

Pediatric Indication
Genetic Immunity is developing a DermaVir Patch nanomedicine candidate to address the significant unmet need among HIV-infected children and adolescents for a safe and effective therapy. This patient population is often neglected because diagnosis and treatment are more difficult, and the market opportunity less significant, in comparison to HIV-infected adults.

The plasmid DNA contained in the pediatric DermaVir Patch is derived from an HIV-infected baby with the Clade "C" virus, which is the most common HIV sub-type among children worldwide. With the exception of a different plasmid DNA for the Clade C subtype, the pediatric nanomedicine candidate is based on the same NanoComp composition, capabilities, scalable manufacturing process, therapeutic platform and IP as the DermaVir Patch for adults. By leveraging similar capabilities for both product candidates, Genetic Immunity can realize value from addressing the pediatric population based on the following:

• Immune system functions better at a younger age and therefore immune amplification therapies may be even more effective in children and adolescents than adults. This idea is supported by data on certain prophylactic vaccines (e.g., HPV vaccine) that have only demonstrated efficacy in inducing an immune response among younger people
• Safety and immunogenicity data to date on the DermaVir Patch support development in the pediatric indication
• Burden of administering current drug "cocktails" at least once daily demonstrates the need for an alternative therapy that offers a less frequent and more desirable administration schedule and delays the initiation of daily life-long treatment options
• Smaller HIV-infected pediatric patient population offers faster potential route to U.S. and E.U. marketing approvals