August 10, 2005

Polydex Pharmaceuticals provided an update of ongoing human clinical trials of Ushercell, a cellulose sulfate gel envisioned for use as a contraceptive and for the prevention of HIV and other sexually transmitted diseases.

The first of the two Phase III trials was initiated at two sites in Nigeria under the collaboration of CONRAD and Family Health International, with continued support from the U.S. Agency for International Development (USAID). Investigators report having enrolled more than 400 participants in this trial that seeks to enroll 2,160 HIV-negative women at high risk of HIV infection.

The second Phase III trial was initiated with grant funding provided by USAID and the Bill and Melinda Gates Foundation and Investigators report that screening of participants is underway at sites in Uganda and South Africa. This trial will evaluate Ushercell for the prevention of HIV infection among 2,574 adult women at high risk of acquiring HIV. This study will also assess incidence of genital gonorrhea and chlamydia. Uganda and South Africa are the first of six locations to be involved in the trial; other sites include Benin, Burkina Faso and two centers in India.