Nile Therapeutics, Inc. a company focused on the development of novel therapeutics for heart failure patients, announced plans to collaborate with Medtronic, Inc. on the clinical development of Nile's proprietary natriuretic peptide, cenderitide (formerly CD-NP), for heart failure and renal disease applications.

“We are very pleased to partner with Medtronic on cenderitide,” said Joshua Kazam, chief executive officer of Nile Therapeutics. “This collaboration will be an important step on our path to developing cenderitide as a potential new therapy for patients with cardiovascular and renal disease following hospitalization for acute heart failure.”

Under the terms of the agreement, Medtronic will fund and provide its drug-device expertise as Nile executes on its phase I clinical trial to assess the pharmacokinetics and phamacodynamics of cenderitide delivered through Medtronic diabetes pump technology. In the planned clinical trial, cenderitide will be delivered to heart failure patients for up to 24 hours through continuous subcutaneous infusion. Nile expects to complete the trial by the first quarter of 2012. Financial terms were not disclosed.

Following the phase I study, Nile intends to initiate a larger phase II double-blind, placebo-controlled, dose ranging study in patients admitted to the hospital for acute heart failure. The planned phase II study will evaluate the endpoints of cardiac remodeling, renal function, re-hospitalization and mortality in patients following 90 days of continuous therapy via subcutaneous pump.

The first 90 days following admission to the hospital is a critical time for heart failure patients who are known to have combined rates of re-admission and mortality as high as 50 per cent during that period. Nile believes that the cardiac unloading and renal preserving properties of cenderitide could have a significant benefit to patients during a critical time in their recovery from acute heart failure.

Heart failure is the fastest-growing clinical cardiac disease in the US according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the US each year are hospitalized with ADHF, an acute exacerbation of heart failure. This hospitalization rate is almost double the rate seen 15 years ago, and is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $33 billion.

Nile Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs.