This second clinical protocol for Chemophase is designed to evaluate multiple intravesical (into the bladder) administrations of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer, and follows the completion of the initial phase I trial of single-administration Chemophase and mitomycin.
The dose-finding phase I/IIa study will enroll up to 36 evaluable patients with superficial bladder cancer. The objectives of the study include determining the maximum tolerated dose and dose-limiting toxicities, if any, of escalating doses of Chemophase in combination with mitomycin; 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.
In March, Halozyme presented new preclinical data along with pharmacokinetic data from the phase I clinical trial of Chemophase combined with chemotherapy. The results, Halozyme says, support the safety profile for Chemophase.