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- Posted Tuesday April 9, 2013
TGen-Scottsdale Healthcare clinical trial results for BIND-014 presented at AACR 2013 Annual Meeting
BIND Therapeutics' nanoparticle drug is shown effective against multiple solid tumors in Phase 1 study at Virginia G. Piper Cancer Center
WASHINGTON, D.C. - April 9, 2013 - The
nanoparticle drug BIND-014 is effective against multiple solid
tumors, according to results generated by the Translational
Genomics Research Institute (TGen) and Scottsdale Healthcare, and
presented today at the American Association for Cancer Research
(AACR) Annual Meeting 2013.
Data for the study was generated at the Virginia G. Piper Cancer
Center Clinical Trials, a partnership of TGen and Scottsdale
Healthcare.
Dr. Daniel Von Hoff, TGen Physician-In-Chief and Chief Scientific
Officer of Scottsdale Healthcare's Clinical Research Institute,
will present A Phase 1 Study of BIND-014, a PSMA-targeted
Nanoparticle Containing Docetaxel, in Patients with Refractory
Solid Tumors during an AACR session at 1 p.m. EDT today at the
Washington, D.C., Convention Center, Room 146.
Dr. Von Hoff, the study's Principal Investigator, will present
complete Phase 1 clinical data of BIND-014, which is produced by
BIND Therapeutics, a clinical-stage biopharmaceutical company
developing a new class of highly selective targeted and
programmable therapeutics called AccurinsTM. BIND-014 is the
company's lead drug candidate.
In 28 patients with advanced or metastatic solid tumors, BIND-014
- with its targeted docetaxel Accurin - was 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 lasting at least four, 12-week-plus
cycles. 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 Dr.
Von Hoff, F.A.C.P., TGen's Distinguished Professor. "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
Dr. Gregory Berk, 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, which 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.
Dr. Von Hoff's presentation of BIND-014 is 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.
This clinical study was conducted at the Virginia G. Piper Cancer
Center at Scottsdale Healthcare in Scottsdale, Arizona, in
collaboration with Phoenix-based TGen, the Scottsdale Healthcare
Research Institute, Karmanos Cancer Institute in Detroit, Marin
Specialty Care in Greenbrae, Calif., 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.
*
About BIND Therapeutics
BIND Therapeutics is a clinical-stage biopharmaceutical company
developing a new class of highly selective targeted and
programmable therapeutics called AccurinsTM. BIND's Medicinal
Nanoengineering® platform enables the design, engineering and
manufacturing of Accurins with unprecedented control over drug
properties to maximize trafficking to disease sites, with the
objective of enhancing efficacy while minimizing toxicities. BIND
is developing a pipeline of novel Accurins that hold extraordinary
potential to become best-in-class drugs and improve patient
outcomes. BIND's lead product candidate, BIND-014, is currently
entering Phase 2 clinical testing in cancer patients and is
designed to selectively target PSMA, a surface protein upregulated
in a broad range of solid tumors. BIND also develops Accurins in
collaboration with pharmaceutical and biotechnology partners to
enable promising pipeline candidates to achieve their full
potential and to utilize selective targeting to transform the
performance of important existing drug products. BIND is backed by
leading investors, including: Polaris Venture Partners, Flagship
Ventures, ARCH Venture Partners, NanoDimension, DHK Investments,
EndeavourVision and Rusnano. BIND was founded on proprietary
technology from the laboratories of two leaders in the field of
nanomedicine, Professors Robert Langer, David H. Koch Institute
Professor of the Massachusetts Institute of Technology (MIT) and
Omid Farokhzad, Associate Professor of Harvard Medical School. For
more information, please visit the company's web site at www.bindtherapeutics.com.
Media:
Kathryn Morris
The Yates Network
Tel: 845-635-9828
[email protected]
*
About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in
Scottsdale, Ariz. offers comprehensive cancer treatment and
research through clinical trials, diagnosis, treatment, prevention
and support services in collaboration with leading scientific
researchers and community oncologists. Scottsdale Healthcare is the
nonprofit parent organization of the Virginia G. Piper Cancer
Center at Scottsdale Healthcare, Scottsdale Healthcare Research
Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale
Healthcare Shea Medical Center and Scottsdale Healthcare Thompson
Peak Hospital. For more information, visit www.shc.org.
Press Contact:
Keith Jones
Public Relations Director
Virginia G. Piper Cancer Center at Scottsdale Healthcare
480-323-1383
[email protected]
*
About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix,
Arizona-based non-profit organization dedicated to conducting
groundbreaking research with life changing results. Research at
TGen is focused on helping patients with diseases such as cancer,
neurological disorders and diabetes. TGen is on the cutting edge of
translational research where investigators are able to unravel the
genetic components of common and complex diseases. Working with
collaborators in the scientific and medical communities, TGen
believes it can make a substantial contribution to the efficiency
and effectiveness of the translational process. For more
information, visit: www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
