
Select interim results were presented from an ongoing Phase 1 clinical trial evaluating the safety and preliminary efficacy of TH-302 in patients with advanced solid tumors. The clinical trial was designed with an initial accelerated titration design followed by a standard dose escalation schema. The trial has completed the accelerated titration design component and has enrolled the eighth dosing cohort. The weekly dose has been escalated from the initial dose of 7.5 mg/m2 to 670 mg/m2. None of the 20 patients enrolled to date has experienced any dose limiting toxicities (DLTs). Importantly, one patient with refractory small cell lung cancer metastatic to the liver had a partial response at their initial response assessment with a greater than 45% reduction in target lesion diameters. The patient, who has received two cycles of TH-302 at 480 mg/m2, is being followed by RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Additionally, this patient experienced a marked improvement in liver function tests. Other anti-tumor activity observed include one patient with non-small cell lung cancer with tumor shrinkage lasting over 6 months... Threshold Pharmaceuticals' Press Release -