AmVac Initiates Phase III Trial with its Lead Vaccine Gynevac for the Treatment of Bacterial Vaginosis

Zug, Switzerland (ots) - 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 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."

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.

About Gynevac

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.

About AmVac

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: www.amvac.eu

Contact:
Marie-Christine Kopkow, Head of Operations T: +41 (41) 7253230,
E: kopkow@amvac.eu
AmVac AG, Metallstrasse 4, 6300 Zug, Switzerland