June 17, 2014
Swiss-based AmVac AG, a private biotech company focused on the development of innovative vaccines, announced today 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 inJune 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.”
About bacterial vaginosis (BV)
BV 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. The disease occurs as the result of disbalance in vaginal ecosystem. Typical symptoms include abnormal discharge, burning, itching and discomfort. BV is particularly critical because it is also a door opener to serious secondary infections, such as HIV and other sexually transmitted diseases (STD). Further, the association of BV with preterm birth is confirmed by numerous studies. The current standard therapy is antibiotic treatment, which is associated with undesired side effects, e.g. development of antibiotic resistance or allergic reactions. Moreover, the protective vaginal flora often does not recover completely. As a consequence, disease recurrence rates after antibiotic treatment is high. Clinical studies with the previous version of Gynevac showed dramatic improvements in terms of efficacy, safety and long-term protection.
Gynevac is a therapeutic vaccine, which is based on an unique blend of inactivated lactobacilli strains. The previous version, that gained marketing authorization in 1997, was labeled “for the treatment of acute, sub-acute and chronic gynecological inflammations caused by bacteria and trichomonas”. This previous version of the vaccine has since then been applied successfully to over 200,000 patients, with long-term positive clinical outcome and not a single case of severe side-effect. AmVac has improved the formulation and adapted quality control methods and the production process to current GMP standards.
AmVac AG is a private biotech company that develops and markets innovative vaccines. With headquarter in Switzerland, research laboratories in Germany and Italy and a production facility in Hungary, the company brings together leading European expertise in the field. AmVac’s portfolio currently comprises five vaccine candidates and three platform technologies: the Gynevac, Sendai and MALP platforms, in-licensed from a Hungarian partner and renowned German research institutes of the Helmholtz Association and the Max Planck Society. Further vaccine candidates are currently in different stages of development. Target indications include respiratory infections, seasonal and pandemic flu, leishmaniasis etc.
For further information visit: http://www.amvac.eu