D-Pharm stroke treatment trial flops
Clal Biotechnology subsidiary's announcement of failure of Phase III trial for its ischemic stroke treatment sends its stock crashing 80%. Chairman Ruben Krupik: Treatment didn’t deliver goods all way through
The findings will be reexamined by an independent group of statisticians.
The statement appeared in the trial's interim result report, which included the first 350 participants who ended the observation period.
As reported in the statement, the company immediately halted the recruitment of new participants for the trial. Participants under observation will continue to be monitored and participants who have just begun to receive the treatment will be given the choice of quitting or continuing with the trial.
At the same time, company Chairman Rubin Krupik said chances of results becoming positive were slim and there would be no point in filing for FDA approval.
"This is the nature of the industry and the clinical findings determine the outcome. There is always a risk. We join a list of companies which have failed after being the leaders in the field," said Krupik.
He noted that the steering committee determined that the quality of the company's management throughout the trial was good.
"This no doubt, is an unfavorable day for Israel's biotech industry. The treatment did not deliver the goods all the way through and I hope we can muster the strength to continue daring, knowing the risks. The company's board of directors will make further decisions in the near future," he added.
The trial failure was publicized after the company postponed the release of the Phase III trial interim results report for its leading treatment of ischemic stroke last July without an explanation.
The original report was scheduled for release by the end of 2011; however, D-Pharm reported it would be released in the first quarter of 2012.
According to IBI investment House analyst Natali Gotlieb, "D-Pharm attempted to develop a product for a condition which has no effective treatment and is the third biggest cause of death in the world and a cause of disabilities that incur costs in the billions of dollars, and therefore hopes for success were high.
"Although experience shows that leading successful companies attempted to develop such a product, D-Pharm's chances were slim."
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