Date: 2015-02-05
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) 2015 Congress
Company: Genticel (France)
Product: ProCervix®
Action
mechanism: ProCervix® is an investigational vaccine designed to cure women who are already infected by the HPV16 or HPV18 virus types. It uses the Adenylate Cyclase (CyaA), a protein vector delivering the E7 antigens from HPV 16 and HPV18. The CyaA vector directly targets professional antigen presenting cells. Through its unique delivery mode, CyaA allows the antigen to induce strong CD4+ and CD8+ T cell responses.
Disease: treatment of adult women already infected with human papillomavirus (HPV) genotype 16 or 18
Therapeutic area: Infectious diseases
Country: Belgium
Trial
details: 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 were to evaluate the safety and immunogenicity of ProCervix in combination with a commercially available product as adjuvant. The trial has included ascending dose cohorts as well as a placebo-controlled, double-blind, randomized extension.
Latest
news: * On February 5, 2015, Genticel, a French biotechnology company and leading developer of therapeutic vaccines, announced that data obtained with ProCervix®, its lead therapeutic vaccine, will be presented in the EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) 2015 Congress taking place at the FIBES II Conference and Exhibition Centre in Seville, Spain on February 4 – 7. EUROGIN 2015 will highlight ProCervix®, Genticel’s most advanced candidate therapeutic vaccine, through two oral presentations about its continuing clinical development. ProCervix® is designed to induce the elimination of cervical cells infected with HPV 16 and/or HPV 18. Both presentations provide further analysis of ProCervix’s phase 1 data and expand on the rationale that led Genticel to embark on the phase II trial back in 2014. The first one (ProCervix®, a new vaccine for HPV16&18 infected women prior to development of high-grade cervical lesions: from phase I to phase II) has been presented by Pr Pierre Van Damme (University of Antwerp, Belgium). The second one showed the evaluation of HPV clearance following ProCervix® vaccination in HPV16/18 infected women with normal cytology. * On October 18, 2012, Genticel, a biopharmaceutical company developing innovative vaccines for patients infected with human papillomavirus (HPV), 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.
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.
* On November 2, 2011, Genticel has completed the recruitment of all patients participating in its Phase 1 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.
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®. 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.
