FDAnews
www.fdanews.com/articles/96434-threshold-pharmaceuticals-initiates-phase-i-clinical-trial-evaluating-th-302

Threshold Pharmaceuticals Initiates Phase I Clinical Trial Evaluating TH-302

July 27, 2007

Threshold Pharmaceuticals announced that it has initiated a Phase I clinical trial evaluating the safety of TH-302, the company’s first hypoxia-activated prodrug (HAP), in patients with advanced solid tumors.

According to Threshold, approximately 50 patients with advanced solid tumors are planned to enroll in the U.S.-based, open-label, dose-escalation Phase I trial.

Up to six patients per dose level will participate in the dose-escalation phase of the trial. Once a maximum tolerated dose (MTD) has been established, six additional patients will be enrolled at the MTD level, the company added.

TH-302 will be administered as a 30-minute intravenous infusion weekly for three weeks followed by one week off therapy, the company said.

Patients who have received one or more regimens of chemotherapy, or for whom no effective therapy is available, are eligible for the trial. Patients will not receive any additional chemotherapy while receiving TH-302, the company added.

Patients who successfully complete a four-week treatment cycle without evidence of significant treatment-related toxicity or progressive disease will continue to receive treatment for up to six cycles. Tumor response will be measured at the end of cycles two, four and six.