Pharmacyclics begins phase II trial of Xcytrin in lung cancer

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

The phase II 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.

“Our strategy is to build upon the experience and activity we have seen with Xcytrin in other lung cancer trials,” said Richard Miller, president and CEO of Pharmacyclics. “We believe that there is an opportunity to expand the use of Xcytrin to the systemic treatment of patients with metastatic disease in addition to its use in treating patients with brain metastases from lung cancer.”

Pharmacyclics is developing Xcytrin as an anticancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is a redox active drug that disrupts redox dependent pathways in cells and inhibits oxidative stress related proteins. The drug has been granted fast track status by the FDA for the treatment of brain metastases (cancer that has spread to the brain from another part of the body) in NSCLC patients.