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CoTherix Initiates Trial of Ventavis in Combination With Sildenafil for Pulmonary Arterial Hypertension
SOUTH SAN FRANCISCO, Calif., March 8 /PRNewswire-FirstCall/ -- CoTherix, Inc. (NASDAQ: CTRX) today announced the initiation of a Phase III trial of Ventavis(R) (iloprost) Inhalation Solution in combination with sildenafil citrate. The trial will evaluate the safety and efficacy of Ventavis in combination with sildenafil for the treatment of pulmonary arterial hypertension (PAH). The trial will also include an arm to explore the efficacy of less frequent Ventavis dosing as suggested by peer-reviewed publications.
The clinical trial, called VISION (Ventavis Inhalation with Sildenafil to Improve and Optimize Pulmonary Arterial HypertensioN), is a double-blind, placebo-controlled trial, in which approximately 180 PAH patients treated with a stable dose of oral sildenafil, a PDE-5 inhibitor, will be randomized to one of three treatment groups for 16 weeks: Ventavis four doses per day; Ventavis six doses per day or placebo. The primary clinical endpoint of the trial is an increase in the distance walked in six minutes. Improvement in New York Heart Association functional class, a delay in clinical deterioration, hemodynamics and safety will also be evaluated.
About Ventavis
Ventavis is approved and marketed in the United States for the treatment of pulmonary arterial hypertension (WHO Group I), a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs, in patients with NYHA Class III or IV symptoms. Ventavis was approved by the U.S. Food and Drug Administration on December 29, 2004, and is marketed in the United States by CoTherix, Inc.
Ventavis Safety Information
In previous clinical studies of Ventavis monotherapy, common adverse reactions due to Ventavis included: vasodilation (flushing, 27%), cough (39%), headache (30%), flu syndrome (14%), nausea (13%), jaw pain (12%), hypotension (11%), insomnia (8%) and syncope (8%); other serious adverse events reported with the use of Ventavis included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Safety trends in patients receiving the combination of bosentan and Ventavis were consistent with those described with Ventavis monotherapy. Vital signs should be monitored while initiating Ventavis. Dose adjustments or a change in therapy should be considered if exertional syncope occurs. Ventavis should not be initiated in patients with systolic blood pressure lower than 85 mm Hg. Stop Ventavis immediately if signs of pulmonary edema occur. Ventavis has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.
About CoTherix, Inc.
CoTherix, Inc. is a biopharmaceutical company focused on licensing, developing and commercializing therapeutic products for the treatment of cardiopulmonary and other chronic diseases, including PAH. CoTherix and the CoTherix logo are trademarks of CoTherix, Inc. Ventavis is a registered trademark of Schering AG. More information can be found at http://www.cotherix.com/ or http://www.4ventavis.com/.
Forward-Looking Statements
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the potential safety and efficacy of combination therapy to treat PAH (such as the combined use of Ventavis and sildenafil), the efficacy of less frequent Ventavis dosing, and the size and design of the VISION trial. All forward- looking statements included in this press release are based upon information available as of the date hereof, and CoTherix does not assume any obligation to update any such forward-looking statement as a result of new information, future events or otherwise. The results of initial clinical trials do not necessarily predict the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through initial clinical trials. CoTherix cannot guarantee that data collected from clinical trials of any combination therapy or less frequent dosing will be sufficient to support FDA or other regulatory approval, or that CoTherix will seek any such approval. Events could differ materially from expectations. Factors that could cause or contribute to such differences include, but are not limited to, factors discussed in the "Risk Factors" section of CoTherix's most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission.
A simple, noninvasive test measures survival time in adult pulmonary hypertension
1-Nov-2006 - Researchers have developed a simple, noninvasive way to measure right ventricular function in the heart to predict survival of adults who suffer from pulmonary hypertension.
The research appears in the first issue for November 2006 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Paul M. Hassoun, M.D., of the Divisions of Cardiology, Pulmonary and Critical Care Medicine at Johns Hopkins Hospital in Baltimore, and 11 associates studied 63 consecutive patients with pulmonary hypertension. After right heart catheterization, these patients underwent a transthoracic echocardiogram to assess right ventricular performance in the heart.
Study participants were mostly female, white and had an average age of 55. Seventy-five percent (47 patients) met the World Health Organization's group 1 diagnostic classification of pulmonary hypertension.
Pulmonary hypertension involves progressive narrowing of the blood vessels in the lungs, which can lead to death. In 2000, 163,000 patients discharged from U.S. hospitals had been diagnosed with primary pulmonary hypertension. Although the problem is difficult to detect in a routine medical exam, doctors see more rapid clinical deterioration in patients who have the greatest degree of right ventricular dysfunction.
To assess the problem, researchers performed a test called tricuspid annular plane systolic excursion (TAPSE), which measures echocardiographic abnormalities in the tricuspid valve. Located between the heart's right atrium and right ventricle, the valve prevents the backflow of blood as it is pumped from the right atrium to the right ventricle.
"We found that a TAPSE of less than 1.8 cm was associated with a greater ventricular systolic dysfunction, as well as right heart remodeling," said Dr. Hassoun. "In addition, survival estimates at one and two years for those with pulmonary arterial hypertension were 94 percent and 88 percent, respectively, for individuals with a TAPSE of 1.8 cm or greater. If the TAPSE was less, the survival rates were 60 percent at one year and 50 percent at two years."
The researchers said that patients with a TAPSE of less than 1.8 cm, showing more advanced right ventricular dysfunction, had a dramatically reduced survival rate over the average follow-up time of 19 months. Patients with a TAPSE of less than 1.5 cm had an especially poor outcome.
"Our results suggest that TAPSE is a robust measure of right ventricular function and a powerful predictor of patient survival in pulmonary hypertension," said Dr. Hassoun.
The investigators noted that they believed the TAPSE test should be incorporated into the echocardiographic assessment of all patients were pulmonary artery hypertension.
Contact: Suzy Martin
smartin@thoracic.org
212-315-8631
American Thoracic Society
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