AstraZeneca doubles trial size for stroke drug
pharmafile | December 13, 2005 | News story | Research and Development | AstraZeneca, stroke
Late stage clinical trials of AstraZeneca’s new stroke treatment have resumed after the company decided to double the number of patients enrolled in the study.
AstraZeneca has been plagued by late-stage safety and efficacy problems, with a number of key drugs, such as anti-clotting drug Exanta, falling at the final hurdle in the last 18 months.
First-in-class stroke treatment Cerovive/NXY-059 is one of the few drugs in AstraZeneca’s phase III pipeline, and the company is determined to ensure it doesn’t suffer the same fate as Exanta.
AstraZeneca has expanded its SAINT II trial from 1,700 to 3,200 patients and now has safety data from 1,597 patients – a costly precaution in terms of time and money, but one the company hopes will pay off.
Following its expansion, the trial has now been cleared by an Independent Data and Safety Monitoring Board (IDMB) and Cerovive is now ready to complete its development, with AstraZeneca planning to file regulatory submissions in the first half of 2007.
US biotech company Renovis licensed Cerovive/NXY-059 to AstraZeneca and welcomed the go-ahead from the safety board.
“The IDMB’s recommendation to continue SAINT II as planned following their review of safety data from the trial is welcome news,” said Corey Goodman, chief executive of Renovis.
“We interpret this recommendation as further support that Cerovive/NXY-059 is well tolerated in acute ischaemic stroke patients. This is an important characteristic of Cerovive/NXY-059 in a population of patients previously found to be highly vulnerable to adverse effects of many other drug candidates tested to date.”
Cerovive is a first-in-class treatment to reduce the effects of stroke, but phase II trial results released in May 2005 were mixed.
Patients taking Cerovive showed statistically significant improvements compared with those taking placebo, according to the Modified Rankin Scale, which measures brain damage and disability.
But no significant difference was found using the National Institute of Health Stroke Scale for ischaemic stroke severity. Consequently, SAINT II is focusing on the first measure to persuade regulators of its efficacy.
SAINT II is studying the drug in ischaemic stroke (which accounts for 80% of cases) while another trial, CHANT (Cerebral Haemorrhagic and NXY-059 Treatment), is investigating its use in another type of stroke, intracerebral haemorrhage.
CHANT is in phase IIb and aims to assess the safety and tolerability of 72 hours intravenous infusion of the drug in adult patients with acute intracerebral haemorrhage.
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