Genticel announces that it has completed the recruitment of all patients participating in its phase one clinical trial with a liquid formulation of ProCervix, its candidate therapeutic HPV vaccine designed for adult women already infected with human papillomavirus (HPV) genotype 16 or 18.
The trial takes place at the 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.
In addition, Belgium’s Federal Agency for Medicines and Health Products (FAMHP) has recently also approved Genticel’s request to extend the phase I trial to confirm the safety of a lyophilized formulation of ProCervix.
“We are delighted with the advancement of this important phase I trial that should provide valuable information with regards to safety, local tolerance and immunogenicity,” said Dr Benedikt Timmerman, CEO of Genticel. “Now we have approval for the evaluation of our new lyophilized formulation, Genticel expects to have completed its full Phase I Program in the first half of 2012 and move on to Phase II before the end of the year.”
About ProCervix
This investigational vaccine, called ProCervix, uses the Adenylate Cyclase (CyaA), a protein vector delivering the E7 antigens from HPV16 and HPV18. The CyaA vector directly targets professional antigen presenting cells (APC). Through its unique delivery mode, CyaA allows the antigen to induce strong CD4+ and CD8+ T cell responses. ProCervix is the first HPV vaccine to leverage the CyaA’s mode of action... [PDF] Genticel's Press Release -
