Swiss-based biotech company AmVac has started a Phase III study of its Gynevac vaccine to evaluate the safety and efficacy in treating the bacterial vaginosis (BV) patients.
Based on a blend of inactivated lactobacilli strains, Gynevac is a therapeutic vaccine and is produced in compliance with existing GMP standards.
Conducted at five clinical centres in Hungary, the trial will study changes in vaginal mucosa and evaluate several immunological markers.
The double-blind and placebo-controlled study will recruit 240 patients and the primary endpoint of the study includes the treatment of BV confirmed by the Nugent scoring system.
Scheduled to complete patient enrolment within nine months, the company is expecting to include the first patient this month.
Containing Thiomersal, the previous version gained marketing authorisation in Hungary in 1997 to treat certain gynecological inflammations and has since then been applied to treat over 200,000 patients suffering from various urogenital conditions.
AmVac CEO Melinda Karpati said: "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."
BV occurs as the result of disbalance in vaginal ecosystem and is among the most common conditions found in women health care settings with an estimated 47 million patients in the five major EU markets, the US and Japan.