The nanoparticle drug BIND-014 is effective against multiple solid tumors, according to new results from a phase I study.
In 28 patients with advanced or metastatic solid tumors, BIND-014 and its targeted docetaxel Accurin were shown to be generally safe and well-tolerated at the established maximum dose of 60 mg/m2. BIND-014 showed encouraging signs of anti-tumor activity, including one complete response, three partial responses, and five patients with stable disease that lasted for at least four cycles of 12-weeks-plus. 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,” said principal investigator Daniel Von Hoff, MD, FACP, and Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona. “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, MD, Chief Medical Officer, 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. This platform 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.
This clinical study was conducted at the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Arizona. The complete phase I results were presented April 9 at the American Association for Cancer Research (AACR) Annual Meeting 2013 in Washington, DC.