CAMBRIDGE, Mass.--(BUSINESS WIRE)--
BIND Therapeutics, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM, announced today that positive Phase 1 clinical data for BIND-014, the companys lead drug candidate, were presented today in an oral presentation at the American Association for Cancer Research (AACR) 2013 Annual Meeting.
Clinical investigators presented the Phase 1 results with BIND-014, its targeted docetaxel Accurin, in 28 heavily-pretreated patients with advanced or metastatic solid tumors. In the study, BIND-014 was shown to be generally safe and well-tolerated at the established maximum tolerated dose of 60 mg/m2 and showed encouraging signs of anti-tumor activity including one complete response, three partial responses and five patients with stable disease lasting at least four cycles (> 12 weeks). In addition, the pharmacokinetic (PK) profile of BIND-014 was substantially different from the published PK of conventional docetaxel.
This Phase 1 trial has successfully established the safety and tolerability profile and maximum tolerated dose of BIND-014 in patients with advanced or metastatic solid tumor cancers, commented Daniel D. Von Hoff, M.D., F.A.C.P., Principal Investigator for the study and Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute (TGen) and the Scottsdale Clinical Research Institute. There is a critical need for targeted treatment options for patients with difficult to treat solid tumors and we look forward to further evaluating the potential of BIND-014 in patients with specific solid tumor types in the near future.
In addition to confirming the safety, tolerability and maximum tolerated dose of BIND-014, these data also provide encouraging signs of anti-tumor activity in a variety of solid tumors, said Gregory Berk, M.D., Chief Medical Officer of BIND Therapeutics. Based on these data, BIND is moving expeditiously to advance BIND-014 into multiple Phase 2 clinical trials in 2013 including non-small cell lung cancer, prostate cancer and bladder cancer.
BIND-014 represents the first targeted and programmable Accurin nanomedicine to reach the clinic from BINDs proprietary drug development platform that creates targeted therapeutics designed to accumulate at the site of disease for high drug concentration and maximum therapeutic effect. BIND-014 employs a combination of a targeted biodegradable nanoparticle and docetaxel, a well-established chemotherapy agent.
In an oral presentation entitled A Phase 1 Study of BIND-014, a PSMA-targeted Nanoparticle Containing Docetaxel, in Patients with Refractory Solid Tumors, Dr. Von Hoff presented complete Phase 1 clinical data of BIND-014 consistent with previously reported preliminary observations in which safety, tolerability and efficacy in multiple tumor types was demonstrated.
This clinical study was conducted at the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Arizona, in collaboration with the Translational Genomics Research Institute and the Scottsdale Healthcare Research Institute, the Karmanos Cancer Institute in Detroit, Michigan, Marin Specialty Care in Greenbrae, California, and the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center.
About Accurins
BIND Therapeutics is discovering and developing Accurins, proprietary new best-in-class therapeutics which have demonstrated superior target selectivity and programmable properties in preclinical studies, offering the potential to improve patient outcomes. Leveraging its proprietary Medicinal Nanoengineering platform, BIND develops Accurins that are designed to outperform conventional drugs by selectively accumulating in diseased tissues and cells. The objective is to provide higher drug concentrations at the site of action with minimal off-target exposure, and the potential to improve efficacy and safety. In addition to target selectivity, the programmable properties of Accurins allow for fine-tuning the pharmacokinetic and biodistribution of drugs, differentiating characteristics which have been demonstrated in preclinical studies.
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BIND Therapeutics Presents Positive Clinical Data at the AACR 2013 Annual Meeting for Lead Accurin Candidate, BIND-014 ...