AmVac Initiates Phase III Trial for the Treatment of Bacterial Vaginosis

19-Jun-2014 - Switzerland

AmVac AG announced the initiation of a Phase III study with AmVac’s lead vaccine Gynevac in bacterial vaginosis (BV). The trial aims to confirm the safety and efficacy of a new generation of the vaccine produced in accordance to the current GMP standards. The previous version, containing Thiomersal, had been approved in Hungary in 1997 for the treatment of certain gynecological inflammations and has since then been applied successfully to over 200,000 patients suffering from various urogenital conditions with no significant side effects recorded.

The placebo-controlled, double-blind, randomized study will enroll 240 patients. The primary endpoint is the treatment of BV confirmed by the Nugent scoring system. In addition, the trial will monitor changes in vaginal mucosa and evaluate several immunological markers. Five clinical centers in Hungary will participate in the trial. AmVac expects to include the first patient in June 2014 and to complete patient enrollment within about nine months.

“Gynevac holds exceptional potential,” Melinda Karpati, CEO of AmVac comments. “Based on past clinical evidence and recently discovered mechanisms of action of Gynevac, we believe that it can change the lives of millions of patients suffering from various abnormalities – including BV and BV related premature delivery in women and possibly chronic prostatitis associated benign prostatic hyperplasia in men. This confirmatory study is an important milestone in our strategy to leverage the vaccine’s full potential and bring it to patients around the world who currently have limited treatment options.”

https://www.bionity.com/en/news/148749/amvac-initiates-phase-iii-trial-for-the-treatment-of-bacterial-vaginosis.html