January 26, 2006 07:36 ET

Polydex Pharmaceuticals and CONRAD Announce Results of Ushercell Contraceptive Trial at Partnering Conference in California

LA JOLLA, CA -- (MARKET WIRE) -- January 26, 2006 -- Polydex Pharmaceuticals Limited (NASDAQ: POLXF) is pleased to announce the results of a clinical trial assessing Ushercell's effectiveness as a contraceptive.

George Usher, President and CEO of Polydex Pharmaceuticals, and Henry Gabelnick, Ph.D, executive director of CONRAD, made today's announcement while attending the 3rd Annual Anti-Infectives Partnering & Deal-Making Summit in La Jolla, CA, where Dr. Gabelnick affirmed, "The data results are very promising. With its strong safety profile and these encouraging efficacy results, we remain confident in our development plan for Ushercell."

The chance of pregnancy in 6 months among typical users of Ushercell was 13.4%. The chance of pregnancy in 6 menstrual cycles of perfect use of Ushercell was 3.9%. Six percent of the participants withdrew early from the study for reasons related to the gel.

These figures compare very well with pregnancy probabilities for nonoxynol-9 (N-9), the only vaginal contraceptive drug marketed in the United States. In a recent study, N-9 gels had 6-month typical use pregnancy probabilities ranging from 14.0 to 22.2%, depending on the dose of N-9, and 6-cycle perfect use probabilities ranged from 8.5 to 15.7%.

This was a Phase II non-comparative contraceptive effectiveness trial, which enrolled 200 couples who agreed to use Ushercell vaginal gel as their primary means of contraception for six months. Over three quarters of the women and their partners reported that they would buy Ushercell to prevent pregnancy.

Mr. Usher said, "I am very pleased to be in La Jolla at this summit, and to be making this announcement with Dr. Gabelnick. Contraception has been a primary objective since we began developing Ushercell. These results are affirmation of CONRAD's command of the development process, bringing skills and resources to Ushercell that Polydex is unlikely to have marshaled without their support. We continue to be grateful to CONRAD for the commitment to this important research."

Ushercell is Polydex's leading human pharmaceutical compound, a cellulose sulphate gel envisioned for topical vaginal use primarily in the prevention of unplanned pregnancies and transmission of bacteria and viruses including HIV/AIDS, gonorrhea, chlamydia, bacterial vaginosis, human papilloma virus and herpes 1 and 2. Preclinical and clinical studies have already demonstrated a high level of safety, and Ushercell is currently engaged in Phase III trials in India and Africa, assessing prevention of HIV and other STDs. Ushercell is also engaged in a phase II clinical trial in Brazil to determine effectiveness in the treatment and prevention of Bacterial Vaginosis.

The contraceptive clinical trials were sponsored by CONRAD, and carried out by Family Health International and the California Family Health Council in Los Angeles, CA, and their satellite clinical sites, with additional supportive funding provided by the Bill and Melinda Gates Foundation.

The development of Ushercell for contraceptive and HIV prevention properties has been supported principally by CONRAD, 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