Genticel has announced that it has started a phase II study with its lead product ProCervix, a therapeutic vaccine designed to induce a curative cellular immune response in patients infected with HPV16 and/or HPV18. The high-risk human papillomavirus HPV16 and/or HPV18 types are responsible for 70 per cent of cervical cancers worldwide.
ProCervix is targeted at women already infected by the HPV16 and/or HPV18 viruses before high-grade lesions or cancer occur. It is the first therapeutic vaccine to address the medical need of this high-risk population, because the preventive HPV vaccines are only effective in people who are not yet infected.
The Phase I study was conducted at the Vaccine and Infectious Disease Institute of the University of Antwerp, Belgium under the direction of Professor Pierre Van Damme. The results indicated that ProCervix has a satisfactory safety, local tolerance and immunogenicity profile.
This study revealed the dose and vaccination regime required for further development. The clearance of HPV virus and maintenance of virus-free status was also markedly higher in the patients treated with ProCervix versus those in the placebo group.
Based on these promising results with ProCervix, endorsed by an international group of experts, Genticel has initiated a randomized, placebo-controlled efficacy Phase II trial. This multi-centric trial has received favorable scientific advice from the European Medical Agency (EMA) and runs across several European countries.
Dr. Sophie Olivier appointed as chief medical officer
Genticel has recruited Dr. Sophie Olivier as chief medical officer to lead the clinical development of its pipeline, in particular the ProCervix phase II trial. Dr. Olivier has over 20 years of experience in gynecology, women’s health and regulatory affairs.
Dr. Sophie Olivier was scientific administrator at the European Medicines Agency (EMA) in London, UK. She was responsible for assessing Pediatric Investigational Plans, in particular vaccines. Prior to EMA, Dr. Olivier also worked for 15 years with Wyeth.
As a senior director, Women’s Health and Bone Repair, she was responsible for designing and implementing international clinical development programs in women’s health, leading to FDA and European submissions.
Dr. Olivier is an MD from Aix-Marseille University. She also holds a Master’s degree in Reproductive Biology and a Science and Statistics Masters from Pierre and Marie Curie University - Paris VI.
“We are very pleased to welcome Dr. Olivier. Her expertise in drug development, especially in vaccines and gynecology, and her experience at the EMA are considerable assets for Genticel, in particular for the ProCervix Phase II trial,” said Benedikt Timmerman, CEO of Genticel. “ProCervix is a first-in-class therapeutic HPV vaccine aimed at treating HPV infected women for whom no therapeutic options currently exist and with only ‘watchful waiting’ as an alternative.”
“I am thrilled to join the team at Genticel and to work on the development of these promising therapeutic vaccines,” said Dr. Olivier. “The phase I for the therapeutic candidate vaccine was successful and I look forward to pursuing its development in Europe and abroad.”