Biocancell Therapeutics Ltd. (TASE:BICL) has received permission from the US Food and Drug Administration (FDA) to change the primary endpoint of its Phase IIb clinical trial of BC-819 for the treatment of bladder cancer.
Biocancell previously believed that it could demonstrate that BC-819 eliminated remaining bladder cancer tumors as well as preventing recurrence. Current practice removes the tumors, but they frequently recur.
This endpoint turned out to be too ambitious, and it will be easier to test the drug only on the prevention of recurrence of tumors. The change increases the success of the clinical trial and the company believes that it will not affect doctors' willingness to use the drug if and when it reaches market. The company believes that preventing the recurrence of tumors is enough to position the drug as an alternative to removal of the bladder.
As part of the change in the trial endpoint, the FDA ordered Biocancell to add six patients to the clinical trial to a total of 39 patients. The company believes that the trial will be completed by mid-2012.
Biocancell is also conducting a Phase I/IIa clinical trial of a drug for the treatment of prostate cancer and a Phase IIb (multicenter efficacy trial) of a drug for pancreatic cancer.
Biocancell's share price fell 2.3% in morning trading to NIS 2.25, giving a market cap of NIS 65 million.
Published by Globes [online], Israel business news - www.globes-online.com - on May 22, 2011
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