Presenting the data at the American Association for Cancer Research (AACR) 2013 Annual Meeting, biopharmaceutical company BIND Therapeutics revealed that phase 1 clinical data for BIND-014, the company's leading drug candidate, have been positive.
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."
- BIND-014 was generally safe and well-tolerated with transient and manageable neutropenia as the dose limiting toxicity. Minimal neuropathy, mucositis, fluid retention, rash, and nail changes were observed.
- Established the maximum tolerated dose of 60 mg/m2 when administering BIND-014 on a once every 3 week (Q3W ) schedule.
- Evidence of anti-tumor activity was shown with BIND-014 at 60mg/m2 in nine out of the 28 patients treated, ranging from one complete response (cervical cancer), three partial responses (non-small cell lung cancer, prostate and ampullary) and five patients with stabilization of disease lasting at least four cycles (> 12 weeks; pancreatic, colorectal, gall bladder, tonsillar and anal cancer).
- The PK profile of BIND-014, characterized by prolonged and elevated encapsulated docetaxel levels, was highly differentiated from published PK of conventional docetaxel.