Prostratin Covance Begins

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Contact: Vincent Cummings  310.358.2423             Michael Shelton: 310.360.3877

AIDS ALLIANCE SIGNS $1.2 MILLION CONTRACT FOR TOXICOLOGY STUDY

AIDS Research Alliance Signs Contract with Major CRO To Complete Pre-Clinical IND Testing of Prostratin as an Anti-HIV Drug Targeting HIV Viral Reservoirs

                       
Los Angeles - (July 12, 2005)  AIDS Research Alliance (ARA) has engaged one of the world's largest pharmaceutical research and development services companies to complete pre-clinical research on prostratin, a compound with may deplete HIV reservoirs in individuals living with HIV/AIDS.  The experiments included in the study are required to complete the Investigational New Drug application to the Food and Drug Administration and initiate Phase I human clinical trials.  This study, at an estimated cost of $1.2 million, should be concluded within the next nine to twelve months.
Prostratin has exhibited two unique anti-HIV indications in studies to date.  Prostratin inhibits HIV infection by decreasing receptors on the surface of healthy cells.  More importantly, it activates HIV expression from cells that are infected with latent HIV, forcing them to produce new virus.  These latently infected cells form hidden “reservoirs” throughout the body, including the brain, lymphoid tissue, bone marrow, and genital tract.   Because HIV is dormant within these cells, the cells appear “normal” and escape the reach of current anti-HIV drugs and the immune system.  HIV reservoirs are the major stumbling block to the eradication of HIV.
People currently infected with HIV could remain so for life without strategies to empty the reservoirs.  One possible strategy involves activating the HIV in the reservoirs, making the cells more detectable by the immune system, and rendering them more susceptible to targeted destruction by other anti-HIV drugs.  Prostratin’s ability to stimulate HIV production may make it a candidate for this strategy, when administered concurrently with ARV to prevent the further infection of healthy cells.

Scientists at the U.S. National Cancer Institute (NCI) initially isolated prostratin from an indigenous Samoan remedy made from extracts of the tropical plant, Homalanthus nutans, and used in native herbal medicine for treatment of hepatitis.
AIDS Research Alliance, a non-profit research clinic based in Los Angeles, learned of the data on prostratin’s anti-HIV properties and obtained the exclusive license from the National Institutes of Health to develop prostratin as an anti-HIV drug.   For the last few years, AIDS Research Alliance has collaborated with prominent AIDS scientists worldwide to conduct research on prostratin.  These experiments to date – in test tubes, animal models and human tissue samples – have all confirmed the promising early assumptions on prostratin.  AIDS Research Alliance has now contracted with a major Contract Research Organization to complete toxicology experiments needed to submit an IND application to the FDA.
This pre-clinical research, which will cost $1.2 million, is being funded by significant gifts from Doug Kinney, the board chair of the National Tropical Botanical Garden in Hawai’i, the Richard Gere Foundation, the AIDS Research Alliance Board of Directors, The Joseph Drown Foundation and the MacDonald Family Foundation.

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