PHARMACYCLICS BEGINS PHASE II XCYTRIN TRIAL

Pharmacyclics has initiated an open-label Phase II clinical trial of Xcytrin Injection, the company's lead cancer therapeutic candidate, as a second-line treatment for patients with non-small cell lung cancer.

The trial is planned to enroll 108 patients with recurrent, metastatic non-small cell lung cancer at 12 sites across the U.S. and Canada. The study will evaluate the safety and efficacy of single agent Xcytrin (motexafin gadolinium) in this patient population.

The trial will enroll patients with metastatic disease who have failed one platinum-based chemotherapy regimen. The primary endpoints are safety and efficacy, as measured by tumor response rate and duration of response. Patients will be randomized to receive either a 10mg/kg dose of Xcytrin every week, or a 15mg/kg dose every three weeks.