Ark Therapeutics Group is making reassuring noises about the ongoing Phase III clinical trial with its lead compound, Cerepro, following the UK biotech’s announcement this week that it had withdrawn its European application for early approval of the malignant glioma treatment through the exceptional circumstances route.
The decision was taken after the European Medicines Agency (EMEA) confirmed that data from the Phase III trial (Study 904) would be needed for approval. Ark had originally filed Cerepro (adenovirus-mediated Herpes simplex virus-thymidine kinase gene) with the EMEA in October 2005. The Committee for Medicinal Products for Human Use subsequently recommended against approval in April 2006.
In a new research update, Ark confirmed that the Phase III trial is now fully recruited with 250 high-grade glioma patients. On 11 July, the independent Data and Safety Monitoring Board (DSMB) met to review the first data from the study. It has since informed Ark that there are no safety issues with the trial, the company said. “No modifications are required either to the protocol or conduct of the trial and the DSMB has advised that it should continue to run as planned,” it added.
The multi-centre, randomised, controlled study, which is being conducted in Europe and Israel, compares the efficacy and safety of Cerepro plus standard care with standard care alone. Trials completed to date have shown that Cerepro extends the life of high-grade glioma patients by 7.5 months on average, Ark noted. Currently most patients will live for only around eight months.
Ark expects now to file for approval of Cerepro, which it hopes will be the world’s first gene therapy product to reach the market, sometime next year.