Cerepro Ph III trial gets DSMB go ahead

UK-based health care group Ark Therapeutics says that the observed side effect profile in a Phase III trial of its developmental cancer treatment Cerepro, an adenovirus mediated treatment for high grade glioma, is consistent with that previously reported. The company added that the independent Data and Safety Monitoring Board observing the program reported that it had no additional concerns and would not be requiring any alteration to the study's protocol.

Cerepro, which is based on a modified cold virus that contains a gene encoding the enzyme thymidine kinase, is delivered via injection following the surgical removal of solid tumors. At this stage, healthy brain cells which surround the tumor site express thymidine kinase. Thymidine kinase converts the drug ganciclovir, which is also delivered to the patient intravenously, to a substance that targets and kills dividing cells at the site, thereby allowing differentiation between non-dividing healthy neurones and the dividing cancerous tumor cells.

Ark said that it has now enrolled 160 patients into the assessment, which is referred to as Study 904, and is aiming to recruit up to 250 in total. Participants are randomized to receive the drug plus standard care or standard care alone. The firm added that studies completed so far indicate that the agent confers an average 7.5 month extension to life expectancy, providing those treated with around 15.5 months survival in comparison with eight months in those who receive the standard treatment alone.