Halozyme initiates dosing in Phase I cancer trial

Halozyme Therapeutics, a biopharmaceutical company, has commenced patient dosing in a Phase I clinical trial with PEGPH20 in cancer patients with refractory solid tumors.

This multi-center, open-label, dose-escalation study will explore the safety, tolerability, pharmacokinetics and radiologic assessment of intravenous administration of PEGPH20 as a single agent with repeat dosing.

The trial will evaluate PEGPH20 over a range of doses and enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be assigned to each dosage cohort.

The primary outcome measures of the study are to evaluate safety and tolerability of PEGPH20 and to determine the recommended Phase II dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity. Translational radiologic, biopsy and pharmacodynamic measurements will also be examined.

Jonathan Lim, president and CEO of Halozyme, said: As a result of our successful investigational new drug submission earlier in 2009, the first clinical trial with PEGPH20 is now underway. PEGPH20 may represent a unique approach and offer a novel mechanism of action for the treatment of solid tumors by targeting the hyaluronan component of the tumor microenvironment.