FDAnews
www.fdanews.com/articles/82038-halozyme-initiates-chemophase-phase-i-clinical-trial

HALOZYME INITIATES CHEMOPHASE PHASE I CLINICAL TRIAL

October 28, 2005

Halozyme Therapeutics has initiated patient enrollment for its Chemophase Phase I clinical trial and has dosed two patients. Chemophase is a novel recombinant therapeutic being developed to enhance the delivery of chemotherapy.

The initial clinical protocol for Chemophase is designed to evaluate a single intravesical (into the bladder) administration of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer. The Phase I study will enroll at least five evaluable patients with superficial bladder cancer. The objectives of the study are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin.