Genticel cleared to proceed with ProCervix trial

French biotech firm Genticel (Euronext Paris: GTCL) says that the independent Data Safety Monitoring Board (DSMB) recommends the continuation, per protocol, of its Phase II clinical trial of GTL001 (known in Europe as ProCervix) in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases.

Half of the 236 vaccinated patients have now reached 12 months post-vaccination. In addition, patient and physician engagement remains extremely strong, with a 98% retention rate of the participants in the study.

“We are very pleased that GTL001 continues to be well tolerated in all Phase II participants. We have also been able to keep a high retention rate in this large study, which reflects the strong unmet medical need for a treatment for HPV-infected women with the early-stage of the disease,” commented Sophie Olivier, chief medical officer at Genticel, adding: “The DSMB found no safety issues that warranted any changes in the conduct of the Phase II trial of our lead candidate.”

Previous encouraging results