Genticel has announced that it has completed the recruitment of all patients participating in its phase 1b clinical trial evaluating a lyophilized formulation of ProCervix, its candidate therapeutic HPV vaccine on adult women already infected with human papillomavirus (HPV) genotypes 16 or 18.
Genticel’s key objectives were to evaluate the safety and immunogenicity of the lyophilized formulation of ProCervix. The company has also been conducting a Phase Ia trial to evaluate a liquid form of this vaccine.
Both the phase Ia and Ib trials took 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.
“Our large phase Ia / Ib trial, on both a liquid and a lyophilized formulation of ProCervix, has successfully completed the recruitment of 47 patients in total and we are expecting the final results before the end of the second quarter 2012,” said Dr. Benedikt Timmerman, CEO of Genticel.
He added “Genticel has already started preparing for the Phase II efficacy trial, scheduled for filing in the second half of 2012.”
ProCervix, an investigational vaccine, uses the Adenylate Cyclase (CyaA) technology, 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.
Unlike preventive HPV vaccines, which can only protect people who have not yet been infected, ProCervix is designed to cure women who are already infected by the HPV16 or HPV18 virus types but before high grade lesions or cancer occurs.
ProCervix is the first vaccine to address the expectations and medical need of this high risk population.