TGen-Virginia G. Piper Cancer Center launches clinical trial for drug to treat lung cancer

September 21, 2011

SCOTTSDALE, Ariz. -- Sept. 21, 2011 -- Patients at Virginia G. Piper Cancer Center Clinical Trials are the first in the nation to participate in a clinical trial to determine the safety, tolerability and preliminary activity of an investigational drug that targets cell-signaling proteins associated with the most common form of lung cancer, as well as other forms of cancer such as lymphomas and neuroblastoma.

The first patient on the study was administered the first dose of AP26113 at Virginia G. Piper Cancer Center Clinical Trials, and the trial is now enrolling additional patients.

AP26113, discovered and being developed by ARIAD Pharmaceuticals Inc. (NASDAQ: ARIA) of Cambridge, Mass., is a small molecule cancer therapy that targets the suppression of two oncogenes associated with non-small cell lung cancer (NSCLC): anaplastic lymphoma kinase (ALK), and epidermal growth factor receptor (EGFR). Oncogenes are those genes with the potential to cause cancer.

"AP26113 targets two oncogenes commonly cited in the lung cancer literature in recent years, ALK and EGFR," said Dr. Glen Weiss, the Principal Investigator for the clinical trial, a partnership of the Virginia G. Piper Cancer Center at Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

"We are the first site in the country to open a new clinical trial with AP26113, which has exciting possibilities," Dr. Weiss said of the Phase 1 and Phase 2 clinical trials planned for the drug. The Phase 1 study has just begun enrolling patients. By Phase 2, the study could include more than 100 patients at 11 clinical trial sites. "If AP26113 proves to be safe and effective, it could make a positive difference for patients with NSCLC and other cancers harboring ALK and EGFR abnormalities."

Dr. Weiss also is Director of Thoracic Oncology at Virginia G. Piper Cancer Center Clinical Trials, the partnership between TGen and Scottsdale Healthcare that treats cancer patients with promising new drugs.

And, Dr. Weiss is the new Chief Medical Officer of the Cancer Research and Biostatistics-Clinical Trials Consortium (CRAB-CTC), a Seattle-based cooperative research network, created by a group of preeminent lung cancer investigators. It represents more than 10 institutes worldwide dedicated to funding and facilitating clinical trials, thereby providing lung cancer patients with newly developed therapeutics as quickly as possible.

"Patients with advanced non-small cell lung cancer should ask their oncologists to have their tumors tested for EGFR mutation and ALK abnormalities. Identifying mutations or abnormalities in oncogenes associated with NSCLC can distinguish patients who are more likely to benefit from a targeted therapy," Dr. Weiss said. "NSCLC accounts for nearly 85 percent of all lung cancers. As many as 7 percent of NSCLC patients will have the abnormal ALK gene, and as many as 17 percent of patients with NSCLC in Western populations are EGFR positive."

AP26113 is a unique dual inhibitor of ALK and EGFR. In May, Pfizer filed its much-touted oncology agent crizotinib, a first-generation ALK inibitor, with regulators in the U.S. and Japan. On Aug. 26, through a fast-track process, the U.S. Food and Drug Administration approved crizotinib, to be sold as Xalkori. AP26113 is designed to overcome resistance to crizotinib and to an EGFR inhibitor called erlotinib, sold as Tarceva and made by OSI Pharmaceuticals Inc.
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The formal name of the TGen-Scottsdale Healthcare study is: Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113.

Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at 480-323-1339; toll free at 1-877-273-3713 or via email at clinicaltrials@shc.org.

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 Phase I 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:
Jamie Houston
Public Relations Coordinator
Virginia G. Piper Cancer Center
480-323-1387
jhouston@shc.org

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. TGen is affiliated with the Van Andel Research Institute in Grand Rapids, Michigan. For more information, visit: www.tgen.org.

Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
syozwiak@tgen.org

The Translational Genomics Research Institute

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