Targeted Cancer Therapy Improved with Ex-Vivo Chemosensitivity Analysis.

Researchers Identify Novel Mechanism to Select Candidates for EGFr Inhibitor Therapy

LONG BEACH, Calif. & CHICAGO -- Researchers at Rational Therapeutics (Long Beach, Calif.) www.rationaltherapeutics.com have reported clinical results obtained with a laboratory technique (Ex-Vivo Analysis of Programmed Cell Death - EVA-PCD[TM]) that accurately identifies patients who are candidates for targeted cancer therapy.

A team led by Robert Nagourney, M.D., laboratory director of Rational Therapeutics and medical director of the Todd Cancer Institute at Long Beach Memorial Medical Center, report that ex-vivo laboratory analysis accurately identified non-small cell lung cancer (NSCLC) patients likely to benefit from the EGFr inhibitor, Erlotinib (Tarceva[TM]). The team's findings are published in the official proceedings of the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO), held June 1-5 in Chicago.

"While targeted EGFr-TKI therapy has proven effective in treating advanced non-small cell lung cancer, response rates remain low in randomly selected patients," said Dr. Nagourney. "We have found that the EVA platform can help doctors select those patients most likely to benefit from the new generation of targeted anticancer therapies."

The researchers used ex-vivo analysis (EVA) to examine tissue from NSCLC patients as part of an IRB-approved assay-directed clinical trial. Patients found sensitive to the EGFr inhibitors received oral Erlotinib at 150mg/day as first line therapy. All of the patients selected responded to this oral therapy, with several achieving long-term remissions. This outcome demonstrates that patients whose cancer cells undergo programmed cell death in the laboratory due to EGFr inhibitor exposure are those who respond to targeted Erlotinib (Tarceva[TM]) therapy. The research team's findings are summarized in an abstract titled, "Clinical Responses to EGFr-TKI's Characterized by Drug-Induced Cell Death in Human NSCLC Primary Cultures" (ASCO Abstract # 07-AB-34058-ASCO).

Traditional anticancer drugs are toxic to both cancerous and normal cells. In contrast, targeted anticancer drugs target cancer cells with specific mutations. While such drugs hold promise, their use requires new methods to enable doctors to accurately and consistently identify patients whose particular type of cancer expresses the drug's specific target.

Dr. Nagourney explains, "Efforts to administer targeted therapies in randomly selected patients often result in low response rates at significant toxicity and cost. While researchers continue to develop molecular probes to select candidates, the ex-vivo platform used in this study serves as a functional profile capable of examining the nuances of cellular response to drugs. To exploit the full potential of targeted anticancer therapies, physicians will need laboratory tests that match patients to specific drugs. We believe the EVA PCD platform is such a test."

About Rational Therapeutics

Founded in 1995, Rational Therapeutics is a pioneering oncology research and testing center specializing in individualized therapy based on ex-vivo chemosentitivity analysis. More information is available at www.rationaltherapeutics.com.