Biocancell Therapeutics Ltd. (TASE:BICL) has obtained the final results of its Phase I/IIa clinical trial for its bladder cancer treatment, BC-819.
Bioccancell CEO Avi Barak said that the results of the trial were good and that the company would begin a Phase IIb trial with 33 patients. The trial would probably begin during the fourth quarter of the year, after the company obtains approval from the US Food and Drug Administration (FDA).
The Phase I/IIa trial was conducted on 18 patients with late-stage bladder cancer, which failed to respond adequately to any other treatment. The trial was designed to test the safety of BC-819, discover the optimal dosage, and provide preliminary indication of its effectiveness.
The trial found no severe side-effects at medium and high dosages. It also determined that subsequent trials would use the highest dosage of 20 mg. The drug was shown to be effective in the test group. All the patients first underwent surgery to remove the tumors, except for one tumor which was left in place as a control. BC-819 is intended to prevent new and more severe tumors.
56% of the patients completed the trial with no new tumors. Patients who developed tumors had received lower dosages. The tumor left in place shrank by at least half in 44% of the patients, and in some cases disappeared altogether. 72% of the patients had some positive response to the drug.
Biocancell had a market cap of NIS 56.8 million at today’s open. The share rose 5.6% by mid-afternoon.
Published by Globes [online], Israel business news - www.globes.co.il - on September 24, 2007
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