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news.Nile Therapeutics, a company focused on the development of therapeutics for heart failure patients, has completed the dose escalation stage of an ongoing Phase II study of CD-NP in patients with acute decompensated heart failure.
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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.
Hsiao Lieu, VP of clinical research for Nile, said: “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.
“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.”
Joshua Kazam, CEO of Nile, said: “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. 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.”