Halozyme starts Chemophase phase 1/2a bladder cancer trial

By Elaine Rigoli

Tampa, Fla., April 26 - Halozyme Therapeutics, Inc. has started patient enrollment and dosed the first patient in its Chemophase phase 1/2a clinical trial.

Chemophase is a novel recombinant investigational therapeutic being developed to enhance the delivery of chemotherapy.

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 1 trial of single-administration Chemophase and mitomycin, the company said in a news release.

This dose-finding phase 1/2a multi-center study will enroll up to 36 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 administered as weekly intravesical instillations for five weeks according to 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 antitumor activity of this combination therapy.

Halozyme is a biopharmaceutical company based in San Diego.

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