August 10, 2005 08:00 ET

Polydex Provides Update on Ushercell Clinical Trials

TORONTO -- (MARKET WIRE) -- August 10, 2005 -- Polydex Pharmaceuticals Limited (NASDAQ: POLXF) is pleased to provide 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 (press release dated October 19, 2004) was initiated at two sites in Nigeria under the collaboration of CONRAD and Family Health International, with continued support from 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 (press release dated May 3, 2005) 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.

The two HIV prevention trials noted above are expected to last approximately three years, with a further year required to evaluate the data.

A clinical trial designed to assess Ushercell's effectiveness at contraception has been conducted in the United States (press release of January 21, 2004), enrolling two hundred couples who agreed to use Ushercell as their contraceptive product prior to each act of intercourse for a period of six months. The data from this clinical trial is currently being evaluated and a study report is expected in mid-2006.

A recent study conducted by the HIV Prevention Trials Network (HPTN 049) evaluated Ushercell in a trial designed to assess changes in pH and vaginal flora with the use of a microbicide. 59 HIV positive women were enrolled in the trial, conducted in the United States. 43% of participants enrolled had Bacterial Vaginosis, a common vaginal disorder, at the time of enrollment. By day 14 of the trial, 89% of the patients with BV that were assigned the use of Ushercell (over the placebo) no longer had BV. As Bacterial Vaginosis may act as a co-factor in the heterosexual transmission of HIV, the impact of vaginal microbicides on Bacterial Vaginosis warrants further study. Preparations for a clinical trial to assess Ushercell as a treatment for Bacterial Vaginosis are ongoing.

CONRAD is a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD is administered through the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA, with the main office located in Arlington, VA.

Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry.

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Note: This press release may contain forward-looking statements, within the meaning of the United States Securities Act of 1933, as amended, and the United States Securities Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals Limited. Actual events or results may differ materially from the Company's expectations, which are subject to a number of known and unknown risks and uncertainties including but not limited to changing market conditions, future actions by the United States Food and Drug Administration or equivalent foreign regulatory authorities as well as results of pending or future clinical trials. Other risk factors discussed in the Company's filings with the United States Securities and Exchange Commission may also affect the actual results achieved by the Company.

Contact Information

  • Contact for CONRAD:
    Annette Larkin
    Email Contact

    Investor Relations for Polydex Pharmaceuticals Limited:
    North Arm Capital Services
    Linda Hughes
    Email Contact