Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clin... (ting toxicities andwe look forward to ad...)

Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial

Date:6/30/2008

ting toxicities and we look forward to advancing the agent into pivotal studies."

Given the success of this ongoing Phase I/IIa trial in determining the dose for subsequent trials and demonstrating the safety and tolerability of induction and maintenance dosing of Chemophase, Halozyme is making preparations to request meetings with FDA and European regulators to discuss the optimal regulatory pathway to drug approval. Based on the outcome of these discussions, Halozyme plans to initiate its Chemophase pivotal clinical program in 2009.

Phase I/IIa Chemophase Clinical Trial Details

The study enrolled 27 patients among four investigational sites. Each patient received fixed doses of 40 mg mitomycin plus doses of rHuPH20 according to assignment to one of five pre-defined dose cohorts. All 15 patients in cohorts one through four have completed induction therapy consisting of six weekly intravesical (into the bladder) instillations of Chemophase, with rHuPH20 doses of 20,000, 60,000, 200,000, and 400,000 Units, respectively. The fifth cohort consisted of 12 patients who received the highest weekly dose of rHuPH20 at 800,000 Units during the induction phase. This cohort has now entered the maintenance therapy period of the study with patients receiving the same Chemophase treatment every three months until the patient reaches two years on study or has a tumor recurrence. Based on the date of enrollment of the last patient, dosing may continue through September 2009.

Tumor recurrences require repeat surgical resections, which can lead to morbidity and may eventually require removal of the entire bladder. Reducing the frequency of recurrence can minimize these adverse consequences. Even with the current standard of care, after transurethral resection of non- muscular invasive bladder cancer followed by currently available intravesical therapy, patients typically experience a tumor recurrence rate of 40% to 85%, of which 50% will recur within the f
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