TORONTO, Aug. 4, 2008 (PRIME NEWSWIRE) -- Polydex Pharmaceuticals Limited (Nasdaq:POLXF) reports that the final analysis from the Phase III clinical trial of Ushercell, a cellulose sulphate gel developed by Polydex primarily for use by women as a topical contraceptive, was published in the New England Journal of Medicine on July 31, 2008. The Phase III clinical trials were conducted to test Ushercell's efficacy in prevention of HIV and other sexually transmitted infections. The trials were halted in January 2007 when an independent review of the interim data revealed a higher than expected incidence of HIV in participants at some trial sites.
The report notes "the suggestion of increased (HIV) risk observed in a secondary per-protocol analysis must be viewed with caution, since data were censored on the basis of a post-randomization factor (product withdrawal) that could have been confounded with group assignment." Contrary to what earlier reports had suggested, this observation clarifies that Ushercell does not appear to increase HIV transmission. The report concludes that Ushercell has no role as an HIV prevention method.
Low adherence to product use has been identified as a common problem in several HIV prevention trials. In this trial, it is reported that adherence to condom and gel use was particularly low during sexual acts with a participant's primary partner. Unfortunately, the primary partner has long been considered a high risk factor for contraction of HIV in the regions of Africa where the trials took place.
As Ushercell has demonstrated a high safety and acceptability profile in thirteen studies conducted by the investigative teams at CONRAD, Family Health International and others within the last decade, and having also demonstrated significant contraceptive properties, Polydex intends to pursue the development potential for Ushercell as a contraceptive, personal lubricant and other potential applications.
George Usher, CEO and President of Polydex said, "Although we are disappointed that Ushercell may not have a role in HIV prevention, we are pleased to clarify the safety of Ushercell and will pursue other avenues of development for this novel compound." He went on to state, "the growth of our core business has become our greatest focus, with newly installed equipment and substantial plant upgrades, we are accepting new orders for our high-quality dextran-based products and negotiating a series of potential future contracts which could significantly increase our revenue stream."
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 contains 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, including, without limitation, statements regarding expectations about future revenues or business opportunities and developments relating to Ushercell, partner relationships or other potential research projects. These statements are typically identified by use of words like "may," "could," "might," "expect," "anticipate" or similar words. 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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