Genticel is expected to conduct the clinical trial in Belgium starting Q3 2010.
ProCervix is composed of two recombinant Adenylate Cyclase proteins (CyaA) in equal parts. One protein carries the E7 antigen of HPV16 and the other carries the E7 antigen of HPV18.
The CyaA vector, the antigen shuttle used in ProCervix, directly targets professional antigen presenting cells upon administration to a patient and delivers the antigen so as to trigger immune responses by both CD4+ and CD8+ T lymphocytes.
Belgium’s Federal Agency for Medicines and Health Products (FAMHP), has approved Genticel’s plans. Entry into Phase I marks a milestone for Genticel, which completed a EUR13.1m fundraising in February 2010.
The trial is expected to take place at the international Centre for the Evaluation of Vaccinations in the Vaccine & Infectious Disease Institute of the University of Antwerp, under the direction of Pierre Van Damme.
Genticel said that the main objective of the trial is to evaluate the safety and immunogenicity of ProCervix, the bivalent therapeutic vaccine developed by Genticel. Preclinical studies of ProCervix demonstrated a fully satisfactory safety profile of this investigational vaccine.
Benedikt Timmerman, CEO of Genticel, said: “ProCervix is designed for women already infected by the HPV16 or HPV18 virus strains.
“This first clinical trial with ProCervix is an important milestone for Genticel that is in line with plans underpinning the capital increase of Euro 13.1m recently achieved by our company.”