May 3 2010
Tikcro Technologies Ltd. (OTC BB: TIKRF) today announced that BioCancell Therapeutics, Inc. ("Biocancell"), concluded the first 18 patient group treated pursuant to a Phase IIb clinical trial of the drug candidate BC-819 for use in superficial bladder cancer. These patients had not responded to conventional treatment (BCG or chemotherapy). This was the first of two groups in a trial totaling 33 patients. Based on the interim results, the U.S. Food and Drug Administration (FDA) approved the continuation of the trial and enrollment of the second and last treatment group of 15 patients.
Tikcro holds 30% of Biocancell, taking into account the conversion of a convertible note and exercise of warrants, and 22% on a fully diluted basis.
Interim Results for Phase IIb Clinical Trial in Superficial Bladder Cancer
The following is a summary of the interim results of the Phase IIb clinical trial. The two efficacy criteria requested in the trial to determine a complete response in a patient were non-recurrence and tumor ablation ("Complete Response").
Originally the U.S. FDA required 5 out of 18 patients to show a Complete Response, but when presented with the interim results above it approved the continuation of the trial.
No Serious Adverse Events related to the drug candidate have been recorded in this clinical trial.
Information Regarding the Clinical Trial
The purpose of this Phase IIb trial is to measure the efficacy and safety of BC-819 at a dose of 20mg. The trial is being conducted in seven medical centers in Israel and one U.S.-based medical center in Arizona by BCG Oncology, PC. The trial is expected to include a total of 33 patients who had not responded to conventional treatment (BCG or chemotherapy), with each participant receiving six weekly treatments of BC-819.
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