Nile completes dosing in Part B of cenderitide Phase I study for ADHF

Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that it has completed dosing the first patient in Part B of the ongoing Phase I study. Part B involves dosing cenderitide with Medtronic's insulin pump technology. 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 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure (ADHF), referred to as the "post-acute" treatment period. This program was recently granted Fast Track status by the United States Food and Drug Administration (FDA).

"In Part A, we evaluated the pharmacokinetics of administering cenderitide through subcutaneous bolus injection," said Hsiao Lieu, MD, Vice President of Clinical Research at Nile. "We congratulate our investigators and our research partners for their outstanding efforts to complete Part A so quickly. We were very pleased with pharmacokinetics, bioavailability and safety of the subcutaneous bolus injection of cenderitide. We expect to achieve our primary objective, which is to determine the subcutaneous dose rates for future clinical studies."

The Phase I clinical trial, which began in April, 2011, is a placebo-controlled study evaluating pharmacokinetic and pharmacodynamic actions of cenderitide when administered to chronic heart failure patients as a subcutaneous infusion or as a subcutaneous bolus injection. The trial is designed to understand the doses required to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. In Part A of the trial, patients received two subcutaneous bolus injections of cenderitide.  In Part B of the trial, patients will receive a 24 hour continuous infusion of either cenderitide or placebo, delivered through Medtronic's subcutaneous pump technology.

"We look forward to results of this Phase I trial, which will provide insight into the potential role of continuous subcutaneous infusion of cenderitide as a renal protective heart failure therapy in the post-acute treatment period," said Ven Manda, Vice President of Medtronic's Ventures & New Therapies.