Cell Genesys, Inc. has reported interim data from the expansion cohort of the Phase 1, multicenter clinical trial of CG0070 in patients with recurrent superficial bladder cancer who had failed therapy with Bacillus Calmette-Guerin (BCG), the current standard of care for this patient population.
Sixteen patients have completed dosing of CG0070 administered once weekly or once every four weeks at the two lowest of three doses being evaluated. Ten of these sixteen patients showed anti-tumor activity as measured by complete response at follow-up cystoscopy.
These data were presented by James M. McKiernan, M.D., vice chairman of urology and assistant professor of urology at Columbia University College of Physicians and Surgeons, at the annual meeting of the American Urological Association being held in Orlando, Florida.
“We are encouraged to see that these additional data support earlier Phase 1 findings that suggest oncolytic virus therapy CG0070 may result in anti-tumor activity in patients with recurrent superficial bladder cancer,” stated Robert J. Dow, MBChB, senior vice president of Medical Affairs and chief medical officer of Cell Genesys.
“We plan to evaluate the data for the remaining patients on this trial and then, together with our partner Novartis AG, determine the next steps for this program,” Dow continued.
The Phase 1, open label, dose-escalation trial was designed to evaluate intravesical (into the bladder) administration of CG0070 in patients with superficial bladder cancer who had failed previous therapy with BCG.
The trial, which has enrolled a total of 35 patients, was designed to first evaluate escalating single-dose levels of CG0070 and was then expanded to evaluate escalating multiple dose regimens administered once weekly or once every four weeks. The primary endpoints of the study were safety and the determination of a maximum tolerated dose. Other endpoints included clinical response based on follow-up cystoscopy and recurrence-free survival.