Toulouse, France, October 19th 2011 - Genticel announces today 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.”
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.
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. “Now that HPV testing is well on its way to become the major primary test in cervical cancer screening, millions of women infected with HPV16 and/or 18 will learn that they are HPV positive before high grade lesions or cervical cancer develops. ProCervix is the first vaccine to address the expectations and medical need of this high risk population,” said Dr Didier Hoch, former president of the joint venture Sanofi-Pasteur MSD, which markets Sanofi-Pasteur and Merck & Co vaccines in Europe. Dr Didier Hoch recently joined the supervisory board of Genticel.
About the Human Papillomavirus (HPV) and cervical cancer
Recent estimates by WHO suggest that world-wide approximately 300 million women are carriers of HPV at any given time. Of these, about 93 million women are infected with HPV16 and/or HPV18 types, and, of this population, approximately 350,000 patients are diagnosed each year to have cervical cancer.
About Genticel S.A.
GENTICEL is a clinical stage biopharmaceutical company, based in Toulouse and Paris, France, which develops vaccines for patients infected with Human Papillomavirus (HPV). Besides ProCervix, other pipeline products include CyaA-based multivalent HPV vaccines with additional virus subtype coverage.
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