Endocyte's PRECEDENT study: DSMB recommends enrollment to continue

Mar 4 2010

Endocyte, Inc., a biotech company developing guided therapeutics and diagnostics for personalized medicine, has announced that an independent data safety monitoring board (DSMB) recommended that enrollment into the PRECEDENT study continue.

“We are encouraged by the continued positive safety profile of EC145 and are pleased with the recommendation by the DSMB to continue the PRECEDENT study”

The PRECEDENT study is a randomized phase 2 clinical trial comparing the company's drug EC145 in combination with pegylated liposomal doxorubicin (PLD/Doxil^®) to PLD alone for women with platinum-resistant ovarian cancer.

The DSMB is an independent group of experts enlisted by Endocyte to review and evaluate the interim safety data generated from the Company's phase 2 PRECEDENT study of EC145, in order to make recommendations regarding the continuation, modification or termination of the trial due to safety concerns. This DSMB recommendation was based on a pre-planned interim analysis of the study data. Study enrollment will continue over the next few months, and final data from the study are expected to be available in late 2010.

"We are encouraged by the continued positive safety profile of EC145 and are pleased with the recommendation by the DSMB to continue the PRECEDENT study," said Ron Ellis, president and CEO of Endocyte. "EC145 represents the first of many drugs to utilize our unique drug guidance systems that deliver highly potent drugs for the treatment of cancer and other serious illnesses, and we look forward to completing this study and rapidly moving this program towards the next stage of clinical development."