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NovaCardia, Inc. Presents Positive Results Of Two Phase II Trials In Late-Breaking Trials Session At Heart Failure 2006 Congress


6/19/2006 11:21:16 AM

HELSINKI, Finland, June 19 /PRNewswire/ -- NovaCardia today presented results from two Phase II trials of KW-3902, a proprietary adenosine A1 receptor antagonist in development for the treatment of congestive heart failure (CHF), at the Heart Failure 2006 Congress taking place in Helsinki, Finland. The results were presented in a Late-Breaking Trials Session on Sunday, June 18th.

The first study, a randomized, double-blind, placebo-controlled dose- ranging study, examined 146 acutely decompensated heart failure (ADHF) patients with kidney dysfunction. The preliminary data suggest KW-3902 has significant diuretic activity over a six hour period after the beginning of administration. When given with furosemide, KW-3902 may allow for preservation of kidney function and earlier discontinuation of intravenous diuretic therapy.

"We are extremely encouraged with the preliminary study findings that suggest that the addition of KW-3902 to standard diuretic therapy may preserve renal function while enhancing diuresis," commented Howard Dittrich, M.D., Chief Medical Officer of NovaCardia. "Since deterioration of renal function occurs frequently in CHF patients and is predictive of increased mortality and length of hospital stay, these findings suggest KW-3902 could be an important addition to the treatment of acutely decompensated heart failure patients."

Results from a randomized, double-blind, placebo-controlled dose escalation exploratory study were also presented as part of the Late-Breaking Trials Session. The study examined 34 patients refractory to diuretics. KW- 3902 resulted in increased hourly urine volume, with relatively preserved kidney function, over a nine hour period compared to placebo. These findings suggest that KW-3902 may prove beneficial in facilitating diuresis in patients refractory to conventional pharmacological therapy while simultaneously protecting kidney function.

Adenosine A1 receptors such as KW-3902 mediate a variety of physiologic functions including regulation of renal fluid balance. Over stimulation of the adenosine A1 receptor during standard diuretic therapy in CHF patients may contribute to worsening kidney function. It is believed that adenosine A1 receptor antagonists may protect against a decline in kidney function seen with diuretic therapy.

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 you 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 its 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.

Contact: Brian Farmer Melissa Hill NovaCardia Porter Novelli Life Sciences 858-509-0455 858-527-3482 bfarmer@NovaCardia.commhill@pnlifesciences.com

NovaCardia

CONTACT: Brian Farmer, NovaCardia, +1-858-509-0455,bfarmer@NovaCardia.com; Melissa Hill, Porter Novelli Life Sciences,+1-858-527-3482, mhill@pnlifesciences.com, for NovaCardia


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