BIND Therapeutics, Inc., a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, today announced that patient dosing is underway in the iNSITE 2 trial, a global, phase 2, two-stage clinical trial of BIND-014 in patients with four tumor histologies.
These diseases (cholangiocarcinoma [bile duct cancer], advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck) each affect fewer than 200,000 patients in the U.S., making investigational drugs for these diseases candidates for orphan drug designation by the U.S. Food and Drug Administration. Stage 1 data readout for the iNSITE 2 trial is expected in the first half of 2016.
“The dosing of the first patient in the iNSITE 2 trial further expands the clinical development opportunities of BIND-014,” said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND Therapeutics. “It also represents a new milestone for the first targeted nanoparticle to enter the clinic by utilizing a rigorous biomarker program that can become a useful aid for more reliable patient selection in the future. The orphan tumor types that we have chosen for iNSITE 2 are all cancers with high unmet need and limited treatment options, representing potential opportunities for rapid development. Our choice was also guided by the activity seen with BIND-014 in our phase 1 trial and the historical role of docetaxel in treating these tumors.”
The open-label, phase 2, multi-center two-stage iNSITE 2 clinical trial is designed to determine the activity, safety and tolerability of BIND-014 and will enroll up to 160 patients. In addition, an imaging and biomarker program that can potentially inform the future clinical utility of BIND-014 is also planned. Additional information on this study can be found at: https://www.clinicaltrials.gov.