Halozyme completes enrollment for superficial bladder cancer

Patient enrollment in this Phase I/IIa trial required stepwise enrollment by escalating dose cohort, with a pause for safety evaluation required after the last patient in the previous cohort had completed at least the first four of the six-weekly study drug instillations.

The company began dosing patients in this trial in April of last year, following the successful completion of the initial Phase I trial of a single-administration of Chemophase and mitomycin. Chemophase is a novel recombinant investigational therapeutic being developed to enhance the delivery of chemotherapy.

The Chemophase Phase I/IIa clinical trial is a multi-center, open label, nonrandomized study to evaluate multiple intravesical (into the bladder) administrations of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer.

This dose-finding study enrolled 27 patients with superficial bladder cancer. The objectives of the study included determining the maximum tolerated dose (MTD) and dose-limiting toxicities, if any, of escalating doses of mitomycin and then Chemophase in combination with mitomycin administered as weekly intravesical instillations for six weeks, consistent with the usual standard of care; establishing the optimal dose of Chemophase with mitomycin to be recommended for future studies; and observing patients for any preliminary evidence of anti-tumor activity of this combination therapy.

Jonathan Lim, Halozyme’s president and CEO, said: “We are pleased to have reached another important milestone in the development of Chemophase, which is proceeding along our expected timeline. We hope to announce interim data from this ongoing trial during the first half of next year.”