BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel. Docetaxel is the active ingredient in Taxotere®, which is approved in major cancer indications, including breast, prostate and lung. In preclinical cancer models, BIND-014 was shown to deliver up to 20 times more docetaxel to the tumor site than an equivalent dose of Taxotere. The increased accumulation of docetaxel at the site of disease in preclinical systems translated to marked improvements in antitumor activity and tolerability.
“The preclinical profile of BIND-014 demonstrating activity against many types of very common cancers is very encouraging”
"Initiating clinical development of BIND-014, our most advanced product candidate, is an important milestone for BIND. Preclinical studies demonstrate the ability of BIND's targeted nanoparticle technology to enhance the trafficking of cytotoxic agents to cancer cells and increase efficacy, which, if confirmed in human trials, has the potential to improve outcomes for patients," said Scott Minick, President and Chief Executive Officer of BIND Biosciences. "By precisely targeting and controlling the exposure of drugs to disease sites, BIND's Medicinal Nanoengineering platform has the potential to produce drug candidates across an array of therapeutic areas including oncology, inflammatory disease and cardiovascular disorders."
The Phase 1 study has an ascending, intravenous dose design to assess the safety, tolerability and pharmacokinetics of BIND-014 in approximately 30 cancer patients. The primary objective of the study is to determine the maximum tolerated dose of BIND-014 and to assess preliminary evidence of antitumor activity. Patients are currently being screened for eligibility in this clinical trial, which is being conducted at the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Arizona in collaboration with the Translational Genomics Research Institute (TGen) and the Scottsdale Healthcare Research Institute.
"The preclinical profile of BIND-014 demonstrating activity against many types of very common cancers is very encouraging," commented Daniel D. Von Hoff, M.D., F.A.C.P., Principal Investigator for the study and Physician in Chief and Distinguished Professor at TGen and Chief Scientific Officer for US Oncology and the Scottsdale Clinical Research Institute. "My colleagues and I are excited to work with BIND in the clinical development of BIND-014 for the benefit of our patients."