News
Final Report of Ushercell as Treatment for Bacterial Vaginosis Released
Polydex Pharmaceuticals Limited (Nasdaq:POLXF) announces that a final report has been received from Dr. Jose Simoes, the Principal Investigator in a Phase II human clinical trial of Ushercell to study the potential treatment and possible prevention of bacterial vaginosis (BV). Bacterial Vaginosis is the most common vaginal disorder among reproductive-age women, commonly associated with several gynecologic and obstetric complications.
The report concludes that this study has reinforced the acceptability and safety of Ushercell, a high molecular weight cellulose sulphate gel (CS), for intravaginal use for five consecutive days. In addition, although this trial showed that CS gel is significantly less effective than metronidazole gel for the treatment of BV, its in vitro properties may still make this product useful as a preventative agent against BV recurrence following antibiotic treatment, and suggests that future studies on this possibility might be worthwhile.
George Usher, President and CEO of Polydex commented that, "Although results from this trial indicate that Ushercell may not be a considerable candidate for treatment of BV, it underlines the possibility that it may be a practical excipient, or carrier of other drugs, in a variety of potential uses as it remains well tolerated and acceptable to women engaged in these important clinical trials."
"Furthermore, Ushercell has demonstrated a pregnancy probability of only 3.9% when used as directed and our strategy is to continue development of Ushercell as a contraceptive alternative, and to seek additional uses for this unique compound, which has repeatedly established that it is as safe and acceptable as marketed spermicides, sexual lubricants and the universal placebo compound."
As part of a long-established research and development program for Ushercell, the BV studies were undertaken as a result of earlier studies that had demonstrated a dose-dependent growth-inhibition effect of BV-associated bacteria in vitro, inhibiting the growth of many bacteria commonly associated with BV.
With positive findings in these early preclinical trials, it was theorized that Ushercell's non-cytotoxic, broad-spectrum antimicrobial activity might inhibit an overgrowth of Gardnerella vaginalis and anaerobic microorganisms, as well as or better than currently marketed products, such as metronidazole. Ushercell was compared with metronidazole in this double-blinded study, to determine comparable effectiveness.
A particularly strict criteria defining the cure of BV was used in this trial, resulting in significantly lower cure rates in women using Ushercell than those on the same regimen using metronidazole (5% vs. 27%, respectively). In total, only eight women of the clinically evaluable participants (out of the sixty enrolled women) were really cured per the protocol of this trial, but most women reported symptomatic improvement either during the phone contact or at the test of cure visits, in both the Ushercell and the metronidazole groups.