"During the quarter we continued to demonstrate the strong potential of our lead compound CD-NP in treating patients with acute heart failure," said Peter Strumph, Chief Executive Officer of Nile. "We are extremely encouraged by our interim Phase 2a clinical trial results to date and look forward to announcing data from the ongoing Phase 1b Maximum Tolerated Dose clinical study of CD-NP in the fourth quarter of 2008. We look forward to continuing to advance the clinical development of CD-NP with the anticipated initiation of our Phase 2b study in early 2009."
Pipeline Development Update
CD-NP
CD-NP is a novel chimeric natriuretic peptide in clinical development
for the treatment of ADHF. CD-NP was designed to preserve the favorable
effects of current therapies while preventing or attenuating the
hypotensive response, and enhancing or preserving renal function. The
Company, in conjunction with The Mayo Clinic, currently has three ongoing
clinical trials, evaluating the potential clinical utility of CD-NP in
patients with acute heart failure.
-- As of the third quarter of 2008, Nile continued enrollment into the
Phase 1b Maximum Tolerated Dose clinical study of CD-NP. The pace of
enrollment is on target with our anticipated announcement of results
from this study by year end. The primary objectives of the study are to
assess the safety and tolerability of intravenous infusions of CD-NP in
patients with heart failure. Key assessments include measurement of
blood pressure, heart rate and kidney function.
-- As of the third quarter of 2008, The Mayo Clinic dosed its first patient
into the National Institutes of Health (NIH) funded Phase 1b Renal
clinical study of CD-NP. The primary objective of this study is to
assess renal, neurohumoral and non-invasive hemodynamic parameters of
intravenous infusions of CD-NP
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