Endocyte announces results from study of EC145 in patients with advanced non-small cell lung cancer

Endocyte Inc. has announced results from a Phase II clinical study of EC145 in patients with advanced non-small cell lung cancer (NSCLC).

Results were presented at the 13th World Conference on Lung Cancer in San Francisco. The single arm Phase II study evaluated the therapeutic agent EC145 and the molecular imaging agent EC20 in 42 patients with advanced adenocarcinoma of the lung. Forty percent of patients involved in the clinical trial had already failed at least four chemotherapy regimens prior to enrollment in the study.

"The data presented indicates the feasibility and promise of EC145 with EC20 imaging as targeted therapy for advanced non-small cell lung cancer," said Martin J. Edelman, M.D., director of medical thoracic oncology at the University of Maryland Greenebaum Cancer Center and principal investigator for the study.

The primary objective for the clinical trial was to determine the percentage of patients who derived clinical benefit from therapy with EC145, where clinical benefit was defined as completing four months of therapy without disease progression. The study showed that at least 30 percent of all patients treated with EC145 achieved this threshold. EC20, a targeted molecular diagnostic imaging agent, was used to identify patients whose tumors expressed the folate receptor, the target of EC145. An analysis of EC20 positive patients receiving EC145 as third or fourth line therapy indicated a clinical benefit rate of 45 percent. Analysis of safety data indicated no significant bone marrow toxicity and that clinical benefit occurred in the context of relatively low toxicity for most patients.

The EC145 molecule uses folate to target the folate receptors found in high concentrations on the surface of tumors, including NSCLC, ovarian, renal and many other cancers. By binding directly to cells that overexpress folate receptors, EC145 delivers the anticancer agent directly to cancer cells while avoiding normal tissue.

"We are encouraged by the positive results that indicate treatment with EC145 may provide clinical benefit to a large percentage of patients with advanced-stage lung cancer," said Richard Messmann, M.D., vice president of medical affairs at Endocyte. "As cancer care enters the age of personalized therapy, it is important to see drug pairs like EC20 and EC145 proceed to the next stage of clinical development. The idea of using a molecular diagnostic imaging agent like EC20 to select patients, followed by treatment with EC145, is exciting because doctors may be able to customize patient care in a way that has not occurred in the past. The fact that most patients who received EC145 also had minimal toxicity indicates that further clinical testing of the combination is clearly warranted."

EC145 is also being evaluated in the PRECEDENT , a randomized, international study evaluating the safety and efficacy of EC145 in combination with Doxil¨/Caelyx¨ in women with advanced ovarian cancer.

Endocyte is a privately held biotechnology company with headquarters in the Purdue Research Park, West Lafayette, Ind. Based on the applications of Endocyte's advanced proprietary Drug Guidance System (DGS), the company is working to develop new drugs and companion diagnostic agents to treat many types of cancer and other serious diseases.