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.