Halozyme Therapeutics Completes Enrollment in Chemophase Phase I/IIa Clinical Trial for Superficial Blad... ( SAN DIEGO Sept. 25 /- Halozyme Th...)

Halozyme Therapeutics Completes Enrollment in Chemophase Phase I/IIa Clinical Trial for Superficial Bladder Cancer

Date:9/25/2007

SAN DIEGO, Sept. 25 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products based on the extracellular matrix, today announced that enrollment is complete in its Chemophase(R) Phase I/IIa clinical trial for the treatment of superficial bladder cancer. 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. 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. 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 Phase I/IIa 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 evidenc
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