Biocancell Therapeutics Ltd. (TASE:BICL), which researches and develops cancer drugs, has reported a successful clinical trial on bladder cancer patients classified as high-risk patients. The company's treatment was proved to be effective and safe in the trial. The US Food and Drug Administration requires success in the trial as a condition for advancing to Phase III clinical trials for BC-819, the company's leading product, which is administered together with BCG, the standard treatment. The company's share price rose 9.5% in afternoon trading on the TASE.
The clinical trials demonstrated for the first time the safety and effectiveness of the combined treatment including BCG on high-risk bladder cancer patients. 17 patients were treated in the trial with three treatments regimens, following removal of all the malignant tumors in the bladder.
The results of the trial were that 11 of the 17 patients (65%) had no recurrence of the malignant tumor for three months from the beginning of the treatment. No severe side effects related to the treatment were diagnosed during the trial.
BioCancell said it planned to continue preparations for further clinical trials, including the production processes necessary for Phase III of clinical trials for BC-819 and promotion of business and commercial development of the drug. BioCancell is holding initial and non-binding meetings, and is considering a number of possibilities for commercial development of BC-819 as a treatment for bladder cancer. The company emphasizes that at this stage, there is no certainty if, when, and under what conditions the negotiations for commercial development of BC-819 will yield positive results.
BioCancell CEO Jonathan Burgin said today, "We're very satisfied with the clinical trial results and the demonstration of the drug's effectiveness and safety for high-risk bladder cancer patients. The clinical results are an important indication that use of BC-819 in combination with BCG is safe. The effectiveness achieved in the trial constitutes further proof of the clinical successes hitherto achieved, and matches the findings in the Phase IIB clinical trial that recurrence of malignant tumors was prevented for three months in 64% of patients."
Published by Globes [online], Israel business news - www.globes-online.com - on September 23, 2014
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