AEGiS-PRn: Ushercell Successfully Completes Phase I Human Clinical Trial of Polydex AIDS, STD Contraceptive Drug

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Ushercell Successfully Completes Phase I Human Clinical Trial of Polydex AIDS, STD Contraceptive Drug

PRNewswire - November 16, 1999

TORONTO, Nov. 16 /PRNewswire/ -- Polydex Pharmaceuticals Ltd. (Nasdaq: POLXF) (BSE: PXL) is pleased to report that Phase I, safety and tolerance clinical study of Ushercell, was successfully completed with minimal evidence of vaginal irritation, by the Contraceptive Research and Development (CONRAD) Program. "The project team is moving full-steam ahead to prepare clinical supplies for long-term toxicology and phase II clinical trials" said Polydex President George G. Usher. "The CONRAD Program is planning parallel contraceptive and anti-STD phase II clinical studies in the US and abroad. We wish to prove Ushercell is effective in a small group of women before initiating the much larger and expensive definitive phase III clinical studies, needed for FDA review for approval." Usher noted that upon successful completion of the full FDA testing and approval process, Polydex would hold the exclusive worldwide license for Ushercell and estimated that the worldwide market might well be $ 1 billion per year.

The clinical study was sponsored by CONRAD's Consortium for Industrial Collaboration in Contraceptive Research (CICCR). Clinical supply production was co-funded by CICCR and Polydex Pharmaceutical Limited.

Ushercell was developed and patented in 1995 jointly by scientists from the Program for the Topical Prevention of Conception and Disease (TOPCAD), Chicago, IL, and Polydex, using matching funds from CICCR. The compound is a high molecular weight cellulose sulfate envisioned for vaginal use primarily in the prevention of heterosexual transmissions of AIDS and other sexually transmitted diseases (STDs) as well as unplanned pregnancies.

Ushercell gel has the texture and appearance of a personal lubricant and is packaged in a single use applicator. The single and multiple exposure tolerance study of Ushercell gel assessed safety (by gynecological examination and subject symptoms) and product leakage. Women were examined before and 12 hours after a single administration of the product, and 12 hours after the last of a week of daily doses. The women practiced abstinence during the study.

TOPCAD's in vitro test results suggest this new antimicrobial-contraceptive agent does not allow the transmission of herpes simplex virus, human immunodeficiency virus, chlamydia trachomatis or the virus that causes cervical cancer. In vitro and animal tests by TOPCAD demonstrate Ushercell interferes with normal sperm function and completely inhibits conception at low drug concentration. Dr. Bill Rencher, Product Development Coordinator at CONRAD/CICCR , will present the laboratory results at the American Association of Pharmaceutical Scientists (AAPS) annual meeting in New Orleans on Tuesday, November 16.

Polydex Pharmaceuticals Limited researches, develops, manufactures and markets biotechnology based products for veterinary, human pharmaceutical and cosmetics industries worldwide. The company is conducting part of its research through collaborations with TOPCAD on this potential female antimicrobial contraceptive product and the University of British Columbia on a potential treatment for cystic fibrosis.

The Contraceptive Research and Development Program (CONRAD) was established in 1986 with funding from the U.S. Agency for International Development, to develop new contraceptive agents that specifically address the needs and perspectives of women and men in less developed countries. It added the mandate to prevent STD transmission in 1987. CICCR commenced operations on October 1, 1995 with initial funding from Rockefeller Foundation and subsequently the Andrew W. Mellon, Hewlett and Gates Foundation and the United Nations Population Fund.

The Program for the Topical Prevention of Conception and Disease (TOPCAD), established in 1993 at Rush-Presbyterian-St. Luke's Medical Center and the University of Illinois at Chicago, IL, USA aims at developing vaginal antimicrobial contraceptive compounds and formulations. A number of scientists from different universities and other organizations in the USA, Canada, Brazil and India participate in the Program.

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

SOURCE Polydex Pharmaceuticals Ltd.

CONTACT: George G. Usher, President of Polydex Pharmaceuticals Limited, 416-755-2231, or Investor Relations, Linda Hughes, Toll-free, 877-945-1621, or northarm@pointbob.net/
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