Biocancell Therapeutics Ltd. (TASE:BICL) today reported success in meeting the goals of its Phase I/IIa clinical trial of BC-819 drug for the treatment of pancreatic cancer. The drug met the trial's safety and preliminary efficacy targets.
The primary end-point of the trial was achieved. There were no side effects that could be directly attributed to BC-819, nor was there any toxicity that might limit the dosage. No patient in the trial reported pain or discomfort from taking the drug.
The secondary end-point was to test the preliminary efficacy of BC-819. The trial found that, after a month of taking the drug, the malignant tumor did not grow in eight of the nine patients. After three months, eight of the nine patients were checked again. Six of the eight patients showed a reduction in the size of the tumor.
After three months, there was a partial response in three of the five patients (60%) taking the high dose (8 mg), in which the local tumor shrank significantly by at least 30%, and no new tumors appeared. Two other patients showed no growth in the tumor (stable disease), and no new tumors appeared.
Biocancell CEO Uri Danon said, "The safety and efficacy results in the Phase I/IIa trial of BC-819 for pancreatic cancer demonstrated the technological potential of Biocancell's technology. After three months, the high dosage resulted in a reduction or stability in tumor size in most of the patients in the trial. The results of this trial, together with the results of the combined treatment of our drug with Gemzar in animals demonstrated greater efficacy than each of these drugs taken alone. In our opinion, these results are solid grounds for continuing the Phase IIb efficacy clinical trial, which will begin soon."
Biocancell's drug rose 6.1% in morning trading to NIS 4.18, giving a market cap of NIS 82 million.
Published by Globes [online], Israel business news - www.globes-online.com - on October 31, 2010
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