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Genticel’s Therapeutic Vaccine, ProCervix for HPV Receives Clearance to Start a Phase I Clinical Trial

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Genticel has announced that it has obtained approval to start a Phase 1 clinical trial with its candidate therapeutic HPV vaccine on adult women already infected with human papillomavirus (HPV). The clinical trial will take place in Belgium starting Q3 2010.

Belgium’s Federal Agency for Medicines and Health Products (FAMHP), has approved Genticel’s plans as has the ethics committee at Antwerp University. Entry into Phase I marks a significant milestone for Genticel, which completed a EUR 13.1 million fundraising in February 2010.

The trial will take place at the leading international Centre for the Evaluation of Vaccinations in the Vaccine & Infectious Disease Institute of the University of Antwerp, under the direction of Professor Pierre Van Damme. The key objectives are 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.

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, is unique because it 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.

“Unlike preventive HPV vaccines, which can protect only people who have not yet been infected and are therefore mainly prescribed for young girls, ProCervix is designed for women already infected by the HPV16 or HPV18 virus strains,” said Dr Benedikt Timmerman, CEO at Genticel. “This first clinical trial with ProCervix is an important milestone for Genticel that is in line with plans underpinning the capital increase of 13.1 Million Euro recently achieved by our company.”