Ark Therapeutics cleared for phase III trial of brain cancer drug
5 January 2007 00:00 in Medical Company Product News
Ark Therapeutics Group has been granted clearance for final stage testing of its brain cancer drug.
The firm has been granted authority by Europe's medicine regulatory safety board to continue testing the experimental drug Cerepro without modification. Phase III trials are therefore to be undertaken on the Ark lead product, which is intended to treat high grade glioma (malignant brain tumour).
Completed trials have so far revealed that treatment with Cerepro produces an average life extension of 7.5 months, meaning patients have around 15.5 months survival for a disease where most live for around eight months.
Dr David Eckland, head of research and development at Ark, said: "This is very solid progress, both in terms of patient recruitment into the trial and with the positive outcome of this latest data review by the DSMB.
"The fact that Cerepro is showing a consistent safety profile is further confirmation that the commercial production and quality standards we have established in Finland are delivering a reliable and predictable product."
Ark is currently seeking regulatory approval from the European Agency for the Evaluation of Medicinal Products for Cerepro, which is the first gene-based medicine to undergo full regulatory review. The review will be completed in the spring of this year, Ark claims.
The firm is a specialist healthcare group which focuses on vascular disease and cancer. A gene medicine company, it develops a range of different products.
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