To date, BioCancell has completed two clinical trials of BC-819 for the treatment of bladder cancer, treating over 80 patients.
A Phase I/IIa trial on 18 patients included repeat intravesical administration of 2-20 mg of BC-819 and showed that the drug is well tolerated. The Maximal Tolerated Dosage (MTD) was not reached, and no Dose Limiting Toxicity (DLT) effects were seen.
As a result, the highest dose (20 mg) was selected for continued development. This dose was selected due to volume considerations and not for tolerability issues. A Phase IIb trial was then run on 39 intermediate-risk NMIBC patients, who had been heavily pre-treated with BCG or chemotherapy, and represent one of our target populations – “BCG-failure patients”.
The trial showed an excellent safety profile with only 6 Severe Adverse Events (SAEs) in 5 patients, and only one of these possibly related to the treatment. There was no discontinuations due to adverse events, and only one discontinuation following patient request.
Efficacy results (lack of recurrence) in both trials were extremely encouraging:
At 3 months (25/39)
At one year (18/39)
At 2 years (13/39)
At 3 months (10/18)
At one year (8/18)
At 2 years (5/17)
A third trial, testing combinations of BC-819 with BCG is currently ongoing.