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 BIND's 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.
- 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.