NovaCardia Presents Phase II Data for KW-3902 at American Heart Association’s 79th Annual Scientific Sessions

NovaCardia announced today that results from Phase II clinical trials of KW-3902, an adenosine A1 receptor antagonist in development for the treatment of congestive heart failure (CHF), were presented in two sessions at the American Heart Association’s (AHA) 79th Annual Scientific Sessions in Chicago, IL. The study findings demonstrate that KW-3902 resulted in the improvement of renal function in CHF patients with renal impairment who were receiving diuretic therapy.

Today’s presentation entitled “The Effect of KW-3902, an Adenosine A1 Receptor Antagonist, on Renal Function and Renal Plasma Flow in Subjects With Heart Failure and Renal Impairment: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study” described results of a study that examined glomerular filtration rate (GFR), a measure of renal function, in 32 stable CHF patients with mild renal impairment treated with furosemide plus KW-3902 compared to furosemide plus placebo. The findings demonstrate that over an eight hour period, KW-3902 provided an increase in GFR of 32.1% over baseline, compared to an increase of 8.3% with placebo (p<0.05). This was accompanied by an increase in renal plasma flow, the likely mechanism whereby GFR is improved, of 47.7% with KW-3902 compared to an increase of 16.0% with placebo (p<0.01). Urine volume over eight hours was also greater with KW-3902 plus furosemide than with placebo plus furosemide.

“Renal function is a strong, independent predictor of both acute and long-term outcomes in patients with congestive heart failure. A drug that can preserve and even increase renal function and at the same time help normalize fluid balance could be an important therapy for those suffering from congestive heart failure,” said Howard Dittrich, M.D., chief medical officer, NovaCardia at the AHA presentation. “We look forward to further evaluating KW-3902 in our ongoing Phase III clinical studies in patients hospitalized with acute heart failure and renal impairment.”

Yesterday at Scientific Sessions, Dr. Michael Givertz of Brigham & Women’s Hospital in Boston presented previously released Phase II data showing that KW-3902 significantly increased urine volume while preserving renal function in CHF patients refractory to diuretic therapy.

Adenosine A1 receptors mediate a variety of physiologic functions, including regulation of renal fluid balance. Stimulation of the receptor during standard diuretic therapy in CHF patients may contribute to worsening kidney function. KW-3902 is intended to block the feedback mechanism by which diuretic therapy may worsen renal function and inhibit sodium reabsorption into the kidney, thereby preserving renal function while facilitating diuresis and ultimately improving short- and long-term outcomes in patients with heart failure.

About Congestive Heart Failure

Congestive heart failure (CHF) is a serious and life-threatening condition that develops when the heart loses its ability to pump blood efficiently and fluid accumulates in the lungs, abdominal organs (especially the liver) and peripheral tissues. According to the American Heart Association, approximately five million individuals in the U.S. are living with CHF, leading to one million hospitalizations per year. With 550,000 new cases reported each year, CHF is the only major cardiovascular disease with increasing incidence, prevalence and mortality. Current CHF therapies have numerous limitations and side effects, particularly in patients with kidney dysfunction.

About NovaCardia

NovaCardia is a privately held product-focused pharmaceutical company with significant capabilities and experience in cardiovascular drug development. The company is committed to improving the quality of care for patients with cardiovascular disease by developing and commercializing novel, clinical-stage drug candidates. For more information, visit www.novacardia.com.

NovaCardia cautions that statements included in this press release that are not a description of historical facts may be forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in NovaCardia’s business including, without limitation, risks related to difficulties or delays in, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for NovaCardia’s products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and NovaCardia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

Contacts:
Brian Farmer
Director of Corporate Development
NovaCardia
858-509-0455
bfarmer@NovaCardia.com

Kim Richards
Media & Investor Relations
Porter Novelli Life Sciences
619-849-5377
krichards@pnlifesciences.com