May 7 2010
Nile Therapeutics, Inc. (Nasdaq: NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced that it has completed the dose escalation stage of an ongoing Phase II study of CD-NP in patients with acute decompensated heart failure. Nile had previously announced that the study, NIL-CDNP-CT005, was expanded to permit additional dose exploration prior to proceeding to larger Phase II studies.
"Following a planned interim safety review with our Data Safety Monitoring Committee and discussion with our Scientific Advisory Board, we have reached our maximum tolerated dose in this population, and have identified two doses that appear to have an attractive safety and activity profile in acute heart failure patients," said Dr. Hsiao D. Lieu, the VP of Clinical Research for Nile. "We plan to use the remaining cohorts in the CT005 study to expand the number of patients exposed at these doses and confirm safety prior to proceeding to our next Phase II study."
"We are extremely pleased with the enrollment rate over the past several weeks, which has allowed us to reach our target dose levels ahead of our original schedule," said Joshua A. Kazam, Nile's CEO. "We feel that this is reflective of the enthusiasm our investigators have for the CD-NP program, and we are excited to continue progressing our clinical plan."
To date, 52 of the approximately 75 patients intended for inclusion in the CT005 study have been enrolled. Full data from the study are expected in late 2010.
SOURCE Nile Therapeutics, Inc.
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