May 15, 2006 07:15 ET

Ushercell Clinical Trial Updates Presented at International Microbicide Conference

TORONTO--(CCNMatthews - May 15, 2006) - Polydex Pharmaceuticals Limited (NASDAQ: POLXF) is pleased to provide an update on the status of clinical trials, from abstracts presented at this year's Microbicides 2006 conference, which was held in Cape Town, South Africa.

The conference was attended by nearly 1,300 delegates from around the world and was heralded as an enormous success and championed for being held, for the first time, on the continent of Africa, the epicenter of the HIV / AIDS pandemic.

Polydex Pharmaceuticals was a co-sponsor of the Conference and was prominently recognized in the Conference Programme, on signage throughout the conference where sponsors were recognized, and on the conference website. "We are proud to have supported this prestigious conference in the beautiful host city of Cape Town South Africa, and to have had the opportunity to share in the excitement of emerging science in the microbicide development field," said Polydex CEO and President, George Usher.

Ushercell was recognized as one of five microbicides leading the late-stage development of a microbicide and the only microbicide engaged in Phase III clinical trials in both Africa and India. These trials will evaluate the use of Ushercell in the prevention of HIV and other sexually transmitted infections. Clinical trial updates were presented by Dr. Lut Van Damme of CONRAD, and by Dr. Vera Halpern of Family Health International, USA.

Dr. Van Damme described the status of Phase III clinical trials of Ushercell (cellulose sulphate) ongoing at 6 sites in 5 countries, and confirmed that 738 participants have been enrolled at these sites. 1779 had been screened and pared down to trial protocol specifications. Patients are screened out of eligibility for a number of reasons including pregnancy, pre-existing HIV or other STI, participant's decision to refrain from enrollment and others.

Dr. Halpern described activities at clinical trial sites in Port Harcourt and Lagos, Nigeria. She reported having screened 2452 women and admitting 1102 into the trial, as of January 2006. The women of Port Harcourt have a higher rate of condom use over the Lagos participants. Consideration is being given to opening another site to increase patient enrollment from a wider population base. The enrollment process has also taken longer than expected, in this case the trial began in January of '05 and it was expected to take twelve months. As of January '06, those sites had enrolled just over half the intended number.

The Associated Press included this coverage of Ushercell from the Conference:

"One of the products, cellulose sulphate, has the potential to be a contraceptive and shield against HIV, the virus that causes AIDS. It is currently being tested for its efficacy in Nigeria, India, South Africa, Uganda and Benin, having undergone safety trials in the United States."

Henry L. Gabelnick, executive director of the U.S.-based reproductive health organization CONRAD that is managing the trials said, "We're happy with the progress we've made so far and we're particularly pleased that the Phase II trials of Ushercell as a contraceptive were so promising."

In addition to the scientific presentations, panel discussions detailed procedures necessary to move a microbicide through international regulatory procedures, prior to potential marketing of any eventual successful candidate. Several humanitarian organizations have pledged their support to purchase safe and effective first-generation microbicides to facilitate the urgent requirements of HIV ravaged communities around the globe. Distribution systems have also been pledged by international organizations with established clinics and experience in family planning and assistance.

Ushercell has been developed with collaborative support from 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 has entered into agreements with CONRAD for the provision of Ushercell product at a fair price for the public sector and retains exclusive worldwide commercial rights for sales in the private sector. Together, CONRAD and Polydex are working to identify third parties interested in entering into licensing agreements with Polydex.

A copy of the Company's Annual Report on Form 10-K, including its complete fiscal year end financial statements, is available at the company website at www.Polydex.com.

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.

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.

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