Published on March 4, 2010 at 1:01 AM
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."
Source Endocyte