Polydex's Ushercell contraceptive gel shows promising results in phase 2 study

By E. Janene Geiss

Philadelphia, Jan. 26 - Polydex Pharmaceuticals Ltd. said Thursday that the results of a phase 2 study to evaluate Ushercell's contraceptive effectiveness were promising and comparable to nonoxynol-9, the only vaginal contraceptive drug marketed in the United States.

Ushercell is a vaginal gel containing 6% cellulose sulfate, which is being developed to prevent pregnancy and sexually transmitted infections, including HIV, according to a company news release.

Previous clinical safety studies have shown Ushercell to be safe for use by women and their male sexual partners, officials said.

Ushercell also is in clinical trials to assess its ability to prevent HIV, gonorrhea and chlamydia infections, the company said.

The chance of pregnancy in six months among typical users of Ushercell was 13.4%. The chance of pregnancy in six menstrual cycles of perfect use of Ushercell was 3.9%, officials said, adding that these figures compare very well with pregnancy probabilities for nonoxynol-9.

Nonoxynol-9 gels had six-month typical use pregnancy probabilities ranging from 14% to 22.2% depending on the dose. Six-cycle perfect use probabilities ranged from 8.5% to 15.7%, officials said.

"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," said Henry Gabelnick, executive director of Conrad, a cooperative agency of the U.S. Agency for International Development, in the release.

Conrad sponsored the study, which was carried out by the California Family Health Council.

The primary objectives of the trial were to estimate the probability of pregnancy for six months of typical use and six menstrual cycles of perfect use of Ushercell.

In addition the study evaluated acceptability, consistency-of-use and adverse events related to the use of Ushercell.

It was a phase 2 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, officials said.

Ushercell was used alone and correctly in more than three-quarters of coital acts in the study. Only 1% of participants in the study were lost to follow-up, an unusually low figure, which allows a high level of confidence in the study results, officials said.

Polydex, based in Toronto, is engaged in 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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