Biocancell gains FDA nod for cancer trial progress

83% of bladder cancer patients in the trial responded to treatment with BC-819.

Biocancell Therapeutics Ltd. (TASE:BICL) has obtained permission from the US Food and Drug Administration (FDA) to continue the Phase IIb clinical trial of the company's BC-819 treatment for bladder cancer, and to begin recruitment of 15 more patients for the second and final stage of the trial.

Biocancell also announced the results of the trial on the first group of bladder cancer patients - 18 out of 33 patients - who failed to respond to standard treatments of BCG or chemotherapy. 15 of these 18 patients (83%) responded to treatment with BC-819. Ten patents (56%) had no recurrence of tumors and nine patients (50%) saw the complete disappearance of cancer signs. Four patients (22%) responded in full, with complete disappearance of the cancer and no recurrence.

The goal of the Phase II trial is to test the effectiveness and safety of BC-819 on patients who failed to respond to one of the current standard treatments for bladder cancer. The company expects to obtain the final results of the Phase II trial in early 2011.

Clal Biotechnology Industries Ltd. (TASE: CBI) owns 18.6% of Biocancell, and its CSO Dr. Avi Hochberg owns 10.4%. Biocancell's share price fell 6.6% by midday today to NIS 3.40, giving a market cap of NIS 75 million.

Published by Globes [online], Israel business news - - on April 28, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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