Second of Two Phase 2 Clinical Studies Initiated with BIND-014 in 2013
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BIND Therapeutics, a clinical-stage
nanomedicine platform company developing targeted and programmable therapeutics
called AccurinsTM, announced today that it has dosed the first patient in a
Phase 2 clinical trial to assess the safety and efficacy of BIND-014, a
PSMA-targeted Accurin containing docetaxel, as first-line therapy in patients
with chemotherapy naive metastatic castrate-resistant prostate cancer.
"While treatment options for metastatic castrate-resistant prostate cancer have
advanced in recent years, primarily due to an increased understanding of
androgen receptor biology, a significant unmet need remains for patients who
fail hormonal agents," said Gregory Berk, MD, Chief Medical Officer of BIND
Therapeutics. "We are pleased our Phase 1 trial of BIND-014 established the
safety profile and appropriate Phase 2 dose, and we are advancing BIND-014 in
clinical development to further evaluate it as a potential treatment option for
patients who are in need of more effective therapies."
"Prostate-specific membrane antigen (PSMA) is an attractive target in patients
with advanced prostate cancer. By delivering an established cytotoxic to this
target, there is the potential to significantly improve the therapeutic index
and patient outcomes," commented Howard Scher, MD, the Chief of the
Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center and
Professor of Medicine at the Weill Cornell Medical College, and principal
investigator of the study.
This 40 patient, open label, single arm multi-center study is designed to
determine the efficacy of BIND-014 as measured by progression-free survival in
patients with chemotherapy-naive metastatic castrate-resistant prostate cancer.
For more specific information on the trial, including patient eligibility and
clinical trial endpoints, please visit www.clinicaltrials.gov (NCT01812746).
BIND-014 represents the first Accurin nanomedicine to reach the clinic from
BIND's Medicinal Nanoengineering(R) platform. BIND-014 targets PSMA, a target
expressed on prostate cancer cells and the blood vessels of many types of
non-prostate solid tumors, and contains docetaxel, a clinically-validated and
widely used chemotherapy drug. Docetaxel is currently FDA-approved for the
treatment of breast cancer, non-small cell lung cancer, metastatic
castrate-resistant prostate cancer, head and neck cancer, and gastric cancer.
Accurins are BIND's targeted and programmable therapeutics, which are designed,
utilizing BIND's medicinal nanoengineering platform, with specified physical and
chemical characteristics to target specific cells or tissues and concentrate a
therapeutic payload at the site of disease to enhance efficacy while minimizing
adverse effects on healthy tissues. Accurins are polymeric nanoparticles that
incorporate a therapeutic payload and are designed to have prolonged circulation
within the bloodstream, enable targeting of the diseased tissue or cells, and
provide for the controlled and timely release of the therapeutic payload. BIND
has demonstrated in preclinical studies that Accurins can improve tumor growth
suppression, achieve higher concentrations of the payload in tumors compared to
the payload administered in conventional form, and have pharmacokinetics and
tolerability differentiated from their therapeutic payloads.
About BIND Therapeutics
BIND Therapeutics is a clinical-stage nanomedicine platform company developing
Accurins, its novel targeted therapeutics. BIND intends to leverage its
medicinal nanoengineering platform to develop a pipeline of Accurins, initially
in oncology, as well as Accurins in collaboration with biopharmaceutical
companies. BIND's lead drug candidate, BIND-014, is an Accurin that targets PSMA
and contains docetaxel, a clinically-validated and widely used cancer
chemotherapy drug. BIND-014 is currently in Phase 2 clinical trials for
non-small cell lung cancer and metastatic castrate resistant prostate cancer. To
date in 2013, BIND has announced collaborations with Amgen, Inc., Pfizer Inc.
and AstraZeneca AB to develop Accurins based on therapeutic payloads from their
product pipelines. BIND's platform originated from the pioneering nanotechnology
research at the Massachusetts Institute of Technology and Brigham and Women's
Hospital/Harvard Medical School of BIND's scientific founders and directors Dr.
Robert Langer and Dr. Omid Farokhzad. For more information, please visit the
company's web site at www.bindtherapeutics.com.
The Yates Network
Gina Nugent, 617-460-3579
Source: BIND Therapeutics