Nile Therapeutics initiates cenderitide Phase I trial in heart failure

Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced dosing of the first patient in a Phase I clinical trial investigating the use of subcutaneous cenderitide.  The trial is being conducted pursuant to Nile's previously announced collaboration with Medtronic and is the first clinical step towards developing cenderitide as a treatment for the post-acute heart failure space, a strategy which was recently granted Fast Track status by the United States Food and Drug Administration (FDA).

"This clinical trial signals the beginning of a new paradigm in the development of therapies for heart failure patients," said James Young, MD Professor and Executive Dean, Cleveland Clinic Lerner College of Medicine. "Administration of cenderitide on an outpatient basis could change how heart failure patients are treated and has the potential to reduce re-hospitalizations by targeting multiple aspects of the heart failure disease process."

The Phase I clinical trial is a placebo-controlled study designed to evaluate pharmacokinetic and pharmacodynamic actions of cenderitide when administered to chronic heart failure patients as a subcutaneous infusion or as a subcutaneous bolus injection. In the first part of the trial, patients will receive two subcutaneous bolus injections of cenderitide.  In the second part of the trial, patients will receive either a 24 hour continuous infusion of cenderitide or placebo, delivered through Medtronic's subcutaneous pump technology. The primary purpose of the trial is to understand the doses required to achieve pre-determined plasma levels of cenderitide delivered through a subcutaneous infusion pump and the pharmacodynamic activity at these doses.

"This clinical trial is a key first step in our post-acute development program. The FDA's recent grant of Fast Track designation and Medtronic's entry into a collaboration agreement to support us in the current trial emphasize the regulatory and commercial interest in cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer.