UK-based drugmaker Ark Therapeutics says that it has completed recruitment in a Phase III trial of its adenovirusmediated anticancer drug Cerepro. The agent, which is being developed for the treatment of operable high-grade glioma, has previously demonstrated the ability to increase survival time in patients suffering from the disease from eight months to 15.5 months (Marketletters passim).
The program, study 904, is designed to compare the efficacy and safety of Cerepro with the current standard treatment in 250 patients suffering from high-grade glioma. Participants will be randomized on a 1:1 basis to receive either Cerepro plus standard care, or standard care alone.
Nigel Parker, the firm's chief executive, said that the rapid recruitment into the trial reflects the enthusiasm for the drug amongst neurosurgeons, and is a further indication of the desire for new gene-based therapies. Ark said that it would undertake manufacture of all supplies of the drug required for trials at its facility in Finland which, it added, is the first in Europe to be approved for the production of gene-based medicines.
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