SOUTH SAN FRANCISCO, Calif., March 8 /PRNewswire-FirstCall/ -- CoTherix, Inc. 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 www.cotherix.com or 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.
CoTherix, Inc.
CONTACT: Anne Bowdidge, Senior Director of Investor Relations of CoTherix,Inc., +1-650-808-6551
Web site: http://www.cotherix.com/
