Polydex begins Ushercell phase 2 trial for vaginal disorder

By Lisa Kerner

Erie, Pa., Jan. 23 - Polydex Pharmaceuticals Ltd. said it has begun a randomized, blinded phase 2 clinical trial of Ushercell, a microbicidal gel being tested for its effectiveness in the treatment of Bacterial Vaginosis.

Bacterial Vaginosis is a clinical syndrome in which the normal vaginal flora is replaced by an overgrowth of Gardnerella vaginalis and anaerobic microorganisms, according to a company news release.

The study, under the direction of Dr. Jose Simoes, at the University of Campinas, Sao Paulo, Brazil, will involve 60 women having a clinical diagnosis of Bacterial Vaginosis and no other sexually transmitted diseases or reproductive tract infections. All participants will be counseled to use an effective non-barrier method of contraception throughout the trial.

The study is expected to last about six months. A report could be available as early as late 2006.

Ushercell is a high molecular weight cellulose sulphate polymer derived from natural cotton. It has successfully completed numerous phase 1 safety and tolerability trials, the company said.

A phase 2 clinical trial testing Ushercell for fertility regulation has been completed in the United States. Two phase 3 trials to determine efficacy in the prevention of HIV/AIDS, gonorrhea, chlamydia and herpes 1 and 2 are ongoing in Africa and India, according to the release.

Earlier published studies indicated that Ushercell demonstrated a growth-inhibition effect on Bacterial Vaginosis-associated bacteria in vitro and recommended further study on the effects of Ushercell as a treatment for Bacterial Vaginosis.

Bacterial Vaginosis is a common vaginal disorder among reproductive-age women, present in 15% to 25% of gynecologic patients, and up to 60% of women seen at sexually transmitted diseases clinics, according to the company. The disorder is also associated with increased risk of HIV acquisition and transmission.

Polydex Pharmaceuticals, based in Toronto, Ont., develops biotechnology-based products.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.