Threshold Pharmaceuticals initiates Phase 2 Clinical Trial of Tarloxotinib

Threshold Pharmaceuticals, Inc.announced that the company has initiated a Phase 2 clinical trial of tarloxotinib bromide, or "Tarloxotinib" (TH-4000), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) or skin (SCCS). Tarloxotinib is Threshold's proprietary, hypoxia-activated, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor licensed from the University of Auckland, New Zealand.
"New and effective treatment options are urgently needed for patients with squamous cell carcinomas," said Danny Rischin, M.D., Co-Director, Division of Cancer Medicine at Peter MacCallum Cancer Centre and Principal Investigator of the Phase 2 trial. "Tarloxotinib represents a novel treatment approach that may allow effective inhibition of EGFR signaling in the tumor microenvironment with relative sparing of normal tissues." "We are pleased that tarloxotinib is actively being investigated in two monotherapy Phase 2 proof-of-concept trials, the other being in patients with non-small cell lung cancer," said Tillman Pearce, M.D.
About the Phase 2 Clinical Trial The Phase 2 clinical trial is a single-arm, open label study that will enroll up to 68 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) or skin (SCCS). Eligible patients will receive tarloxotinib (150 mg/m2 by intravenous infusion) on Days 1, 8, 15 and 22 of a 28-day cycle.  The study is planned to be opened at 10 sites in the U.S. and Australia. For additional information, please visit their website (www.thresholdpharm.com).