Poor Johnson & Johnson and Eli Lilly. They have finally admitted defeat and have permanently halted a clinical trial of their antithrombotic drug ReoPro (abciximab) in patients with acute ischaemic stroke.
Insider noticed the death knell coming when earlier this month the two companies said they were suspending enrolment in the study known as AbESTT-II, because of safety concerns (see story here).
In May, treatment was stopped in a subgroup of the study involving patients who suffered strokes in their sleep because a higher risk of brain haemorrhage was seen with ReoPro. The decision to terminate the entire study came because of a higher than expected rate of brain haemorrhage, said J&J subsidiary Centocor, although as the trial is still blinded it cannot be said with certainty that ReoPro is behind the increase.
ReoPro becomes just the latest in a long list of drugs that have tried - and failed - to have an impact in warding off the debilitating effects of a stroke.
To date the only drug approved to treat the condition remains Genentech/Boehringer Ingelheim's thrombolytic alteplase (see Pharma Times story here).
The actual sales of use of alteplase has, however, been limited, simply because many patients do not reach hospital soon enough after developing stroke symptoms to be eligible for treatment.
Insiders' comment: Insider has previously called stroke "the graveyard of drug development". This should make stockholders of AstraZeneca realize how risky that is. AZ have two Phase 3 drugs Galida (which is like Pargluva!) and Cerovive.......for stroke!
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