Nile Therapeutics to Collaborate with Medtronic on Clinical
Development of Cenderitide for Heart Failure and Renal Disease
SAN MATEO, CA, February
28, 2011 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a company
focused on the development of novel therapeutics for heart failure
patients, today announced plans to collaborate with Medtronic, Inc.
(NYSE:MDT) 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% 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.
About Heart Failure
Heart failure is the fastest-growing clinical cardiac disease in the
U.S. according to the American Heart Association, affecting over 5
million Americans. Over 1 million patients in the U.S. 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.
About Nile Therapeutics
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. 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.
Contact:
Daron Evans
Chief Financial Officer
Nile Therapeutics, Inc.
+1-650-458-2670
info@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 plans to initiate clinical trials 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,
2009 filed with the Securities and Exchange Commission on March 3,
2010. 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.
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