Newswise — FORT WASHINGTON, PA — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has awarded four grants to investigators to evaluate and define the clinical effectiveness of the investigational compound nintedanib* (BIBF 1120) in non-small cell lung, colorectal, and gastrointestinal cancers. These grants were made possible by funding through Boehringer Ingelheim Pharmaceuticals, Inc.

“NCCN is proud to support the research efforts of investigators at NCCN Member Institutions,” said Robert W. Carlson, MD, Chief Executive Officer, NCCN. “These grants, funded by Boehringer Ingelheim, allow researchers to further advance evidence-based medicine through clinical trials at world-class academic cancer centers.”

Nintedanib is an investigational orally-administered triple angiokinase inhibitor that targets three of the receptor tyrosine kinases shown to aid in the regulation of angiogenesis: fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR), and vascular endothelial growth factor receptor (VEGFR). Angiogenesis, or the formation of new blood vessels, is also involved in the growth of cancerous tumors by supplying nutrients and oxygen – often referred to as tumor angiogenesis. [i] All three receptors are associated with tumor angiogenesis, and their blockade may lead to the inhibition of tumor growth and spread. [ii]

The following proposals have been awarded funding: • Patrick Boland, MD, Roswell Park Cancer Institute; A Phase I/II Study of Nintedanib and Capecitabine in Refractory Metastatic Colorectal Cancer

• Ramaswamy Govindan, MD, Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine; A Pilot Study of Nintedanib in Molecularly Selected Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

• Renuka Iyer, MD, Roswell Park Cancer Institute; Multicenter Phase II Trial of Nintedanib (BIBF 1120) in Patients with Carcinoid Tumors

• Alex Adjei, MD, PhD, Roswell Park Cancer Institute; A Phase II Randomized Study Evaluating Nintedanib versus Placebo as Prophylaxis against Radiation Pneumonitis in Patients with Unresectable NSCLC Undergoing ChemoRadiation Therapy

The awardees responded to a Request for Proposals issued by the NCCN ORP to the 25 NCCN Member Institutions. Submissions were peer reviewed by the NCCN Nintedanib Scientific Review Committee. The funded concepts were selected based on several criteria, including scientific merit, existing data, and the types of studies necessary to further evaluate the efficacy of nintedanib.

The NCCN ORP draws on the expertise of investigators at NCCN Member Institutions and the NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer. To date, this successful research model has received approximately $49.5 million in research grants and supported 113 studies that have produced a number of publications in peer-reviewed journals.

For more information about the NCCN ORP and ongoing clinical trials, visit NCCN.org/ORP.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to discover and develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centers, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers. The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. The company is also evaluating a robust and growing pipeline of early-stage oncology compounds in areas including growth/survival signaling, immunotherapy and epigenetics.

For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit www.inoncologyus.com for additional information.

For more information please visit www.boehringer-ingelheim.com.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 25 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.

The NCCN Member Institutions are: Fred and Pamela Buffett Cancer Center at The Nebraska Medical Center, Omaha, NE; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients.

* This compound is investigational and not approved by the U.S. Food and Drug Administration (FDA). Its safety and efficacy have not been established.

[i] National Cancer Institute (NCI). Fact Sheet: Angiogenesis Inhibitors. Available here: http://www.cancer.gov/cancertopics/factsheet/Therapy/angiogenesis-inhibitors. Last accessed February 22, 2013. [ii] Ballas, M., Chachoua, A. National Center for Biotechnology Information. Rationale for targeting VEGF, FGF and PDGF for the treatment of NSCLC. Available here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116793/ Last accessed February 25, 2013.