Genticel has announced positive safety and immunogenicity data obtained in the phase I study with its lead product ProCervix, a vaccine designed to induce a curative cellular immune response in patients infected with HPV16 and/or HPV18.
These high-risk human papillomavirus (HPV) types are responsible for respectively 50 per cent and 20 per cent of cervical cancer world-wide.
ProCervix is targeted at women who are already infected by the HPV16 and/or HPV18 virus types before high grade lesions or cancer occurs. It is the first vaccine to address the medical need of this high risk population as the preventive HPV vaccines are aimed at protecting people who are not infected.
The clinical trial is conducted at the Centre for the Evaluation of Vaccinations in the Vaccine and Infectious Disease Institute of the University of Antwerp, Belgium. The study is directed by Professor Pierre Van Damme.
The key objectives of the trial are to evaluate the safety and immunogenicity of ProCervix in combination with a commercially available product as adjuvant. The trial includes ascending dose cohorts as well as a placebo-controlled, double-blind, randomized extension.
The data indicate that ProCervix plus adjuvant shows good safety and local tolerance at the highest dose evaluated. HPV-E7- antigen specific T cell responses have been detected in a majority of vaccinated women. Moreover, viral clearance is several-fold higher in the group of patients treated with ProCervix than in the placebo group.
“This Phase I trial with ProCervix has met both its primary objective (safety and local tolerance) and secondary objective (antigen-specific cellular immunity),” said Dr. Benedikt Timmerman, chief executive officer of Genticel. “In addition, the results available suggest that ProCervix with adjuvant is clearing the virus in HPV16- or HPV18- infected women.”
“This trial is the first ever to recruit HPV infected women with no cervical lesions; ProCervix may become the first product that actually closes the gap between preventive vaccines and later stage therapeutic options,” said Dr Marie-Christine Bissery, chief scientific officer of Genticel.
Dr Bissery continued, “Additional longer-term clinical data is being collected, including viral clearance in women vaccinated with a reconstituted lyophilized form of ProCervix.”