Nile Therapeutics Provides Update on Ongoing Phase I Clinical Trial of Cenderitide
SAN MATEO, Calif., June 27, 2011 /PRNewswire/ -- 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.
About Nile Therapeutics
Nile Therapeutics, Inc. is a biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is initially focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP, a novel rationally designed natriuretic peptide. More information on Nile can be found at http://www.nilethera.com.
Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Nile's plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, and Nile's ability to obtain FDA approval of cenderitide in the post-acute setting, are forward-looking statements. Forward-looking statements also include statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of cenderitide, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission on March 14, 2011. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
SOURCE Nile Therapeutics, Inc.