TORONTO, Dec. 3, 2007 (PRIME NEWSWIRE) -- Polydex Pharmaceuticals Limited (Nasdaq:POLXF) reports that CONRAD, a lead investigator of Ushercell, has commenced a Phase I trial to assess the safety of several vaginal products, including Ushercell, the Company's leading human pharmaceutical candidate compound. The safety study of 60 women is being done using existing and new methodologies for evaluating candidate vaginal products, and includes new safety markers that have not previously been studied in women using any microbicide candidate. In addition to providing information about these products, the study will look at the correlation between clinical and preclinical results, thereby making it easier to use preclinical studies to eliminate products that may have an inflammatory effect.
This study will recruit 60 women over a six-month period at two sites in the United States. Assigned products to be evaluated in this trial include Ushercell, nonoxynol-9 and a placebo. Follow-up visits over a period of three months will help researchers assess the products' effect on known and exploratory markers of genital inflammation, epithelial integrity, and microflora, and the effect of the vaginal environment on the antiviral activity of each of the products. Final analysis from this trial is not expected for at least eighteen months.
Ushercell has demonstrated a high safety and acceptability profile in thirteen studies conducted by CONRAD within the last decade, and has also demonstrated significant contraceptive properties. The Company intends to pursue all development potential for Ushercell including its use as a contraceptive, personal lubricant and other potential applications.
In January of this year, the Company announced that Phase III clinical trials were halted in Benin, Uganda, South Africa and India, when an interim analysis of data revealed a higher than expected seroconversion rate among participants at some, but not all trial sites. (See news release January 31, 2007.)
It was later announced that the seroconversions between the Ushercell group and the placebo group within those trials were not statistically significant. (See news release July 25, 2007.) CONRAD announced at that time that it would continue its investigation into the trial data and would do additional work to provide a scientific explanation for the seroconversions.
The cause of the higher than expected rate of seroconversions in those halted Phase III HIV prevention trials remains unknown.
Although several hypotheses have been presented and published about the possible cause of the HIV seroconversions within the trial, there remains no evidence to date to suggest that Ushercell caused an inflammatory reaction, or disrupted the normal vaginal flora.
George Usher, CEO and President of Polydex, said, "We remain confident that Ushercell is safe for use in humans as has been demonstrated in a dozen safety trials conducted by CONRAD. Further, Dr. Simoes of the University of Campinas, San Paolo, Brazil reported that although Ushercell did not demonstrate the effectiveness rate in treatment of Bacterial Vaginosis (BV) that he was expecting in the trial he conducted, 'its in vitro properties may still make this product useful as a preventive agent against BV recurrence following antibiotic treatment' and we will continue to pursue development of Ushercell as a contraceptive and potentially as a personal lubricant or in other applications."
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 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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