Biocancell Therapeutics Ltd. (TASE:BICL) today announced positive results in a Phase IIb clinical trial of BC-819 for the treatment of pancreatic cancer. After completing the first stage of the study, there was no deterioration in the condition of patients who received the high dosage of the drug. The drug was also found to be safe by all the patients.
In the study, BC-819 is being administered in conjunction with the standard chemotherapy for pancreatic cancer, gemcitabine. The results reaffirm the positive safety and efficacy results of the previous trials of the drug for this indication.
The 11 patients in the trial were divided into two groups, each of which received a different dosage of BC-819: five patients received an 8-mg dosage, and six patients received a 12-mg dosage. Nine of the patients had no deterioration in the disease for three months (progression-free survival), including all six patients treated with the 12-mg dosage. The Data Safety Monitoring Board (DSMB) found no side effects related to the drug, and there was no difference in safety between the high and low dosages; the severe side effects seen were either related to the disease, to gemcitabine, or to the injection delivery of BC-819 into the pancreas.
In addition, Biocancell plans to publish the final results of the Phases IIb clinical trial of BC-819 for the treatment of bladder cancer during the first quarter of 2013 and it is seeking a partner for a Phase III trial. ___