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Lupus Clinical Trials

New Medical Therapies™

Vaginal Infection

March 3, 2014

Viamet Pharmaceuticals released results of an ongoing phase II study of VT-1161 in patients with moderate to severe acute vulvovaginal candidiasis (AVVC). The AVVC study will enroll approximately 48 patients in three VT-1161 oral dose groups v. oral fluconazole, the current clinical standard of care. Both clinical and mycologic endpoints were evaluated at the test-of-cure visit on Day 28. Effective clinical cure was based upon an improvement in six clinical signs and symptoms of AVVC. Patients were enrolled in the low-dose VT-1161 group, the mid-dose VT-1161 group and the fluconazole control group. In the intent-to-treat population (all randomized patients who received at least one dose of study drug), effective therapeutic cure was achieved in 71% of patients in the low-dose VT-1161 arm, 92% of patients in the mid-dose VT-1161 arm and 80% of patients in the fluconazole arm. VT-1161 was found to be well-tolerated with no serious adverse events reported, and no patient discontinuing VT-1161 due to an adverse event. Based upon the favorable safety and tolerability profile, an additional high-dose cohort currently is being enrolled. Results from this final patient cohort are expected late in the second quarter of 2014. Study continues on oral VT-1161 in a phase II trial in patients with interdigital tinea pedis as a precursor to a larger phase IIb study in patients with onychomycosis, which Viamet expects to initiate later in 2014.

May 30, 2011

StarPharma reported results from a phase II trial of VivaGel for the treatment of bacterial vaginosis. This double-blind, randomized, placebo controlled, dose-ranging study enrolled 132 women who received 0.5%, 1% or 3% gel or placebo gel administered vaginally for seven consecutive days. The primary endpoint was Clinical Cure as defined by no abnormal discharge. VivaGel 1% resulted in 74% of subjects achieving Clinical Cure two to five days after completion of therapy compared with 22% in the placebo group (P≡0.0002). This effect was sustained: two to three weeks after completion of therapy, 46% of subjects achieved Clinical Cure compared with 12% for the placebo (P≡0.006). In addition, unpleasant vaginal odor was cured in 78% of the VivaGel treated subjects. The incidence of adverse events was similar across all placebo gel and VivaGel groups.

April 1, 2002

Results were reported from a phase II randomized, placebo-controlled trial evaluating CTV-05, a strain of human Lactobacillus, for treatment of bacterial vaginosis. The drug was tested in over 400 female subjects as an adjunct to standard metronidazole therapy. Treatment with CTV-05 resulted in vaginal colonization by lactobacillus crispatus in 62% of subjects at 30 days, compared to only 2% of placebo subjects. However, clinical cure rates at 30 days, the primary endpoint of the trial, were not significantly improved with CTV-05 treatment. Satisfactory cure rates were reported in approximately 50% of subjects in both groups. Clinical cure at 30 days was observed in 70% of colonized subjects who received the active drug, compared to 47% who were non-colonized and received placebo, showing that while CVT-05 does not significantly improve cure rates, it does significantly increase colonization rates. CVT-05 is being developed by The Medicines Company.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.