Tracleer and PPH News
CoTherix Initiates Phase II Trial for Ventavis in Expanded Indication
SOUTH SAN FRANCISCO, Calif., June 1 /PRNewswire-FirstCall/ -- CoTherix, Inc. (Nasdaq: CTRX - News) announced today that it has initiated a Phase II trial for its marketed product, Ventavis® (iloprost) Inhalation Solution, to potentially expand the indication to include pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). Ventavis was approved by the Food and Drug Administration in December 2004 for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization Group I) in patients with NYHA Class III or IV symptoms.
The primary objective of the double-blind, placebo-controlled trial, known as the ACTIVE trial (Aerosolized iloprost a Clinical Trial in IPF to Improve Ventilation and Exercise), is to determine the safety of Ventavis in patients with PH associated with mild or moderate IPF. The study will also assess other clinically relevant measures including, the six-minute walk test, NYHA class change and hemodyamic parameters. The study will be conducted in approximately 50 patients at 15 sites in the United States.
"Ventavis is an ideal candidate to investigate for IPF patients with pulmonary hypertension. Since Ventavis is inhaled, we believe it targets only the non-fibrotic portions of the diseased lung, increasing vasodilation only in the ventilated areas and reducing the potential for mismatched ventilation and pulmonary blood flow, which can lead to heart strain and fainting," said James Pennington, M.D., Executive Vice President and Chief Medical Officer of CoTherix, Inc. "With Ventavis already on the market in the United States for PAH, this trial underscores our strategy to continue our leadership position in inhaled therapies for pulmonary diseases."
"Treatment options for these patients are extremely limited," said Richard Channick, M.D., Associate Professor of Medicine at the University of California, San Diego. "There is a significant need for new therapies to treat the pulmonary hypertension complications of this progressive disease. I am very excited about the potential for Ventavis in IPF and look forward to participating in the study."
Idiopathic pulmonary fibrosis (IPF) is a progressive and potentially fatal disease that results in fibrosis, or scarring, of the lungs. In time, fibrosis can accumulate until the lungs are unable to provide oxygen for the tissues of the body. The average survival rate for patients is four to six years after diagnosis. Of the approximately 50,000 people in the United States with IPF, it is estimated that approximately 20% of these patients have pulmonary hypertension associated with their IPF. Currently, there are no approved U.S. therapies for IPF or for pulmonary hypertension associated with IPF.
About Ventavis
Ventavis® (iloprost) Inhalation Solution was approved by the U.S. Food and Drug Administration (FDA) on December 29, 2004 for the treatment of PAH (WHO Group I) in patients with NYHA Class III or IV symptoms. Ventavis is the newest entry into the prostacyclin class of PAH treatments. Prior to the introduction of Ventavis, prostacyclin therapies for PAH required continuous delivery through subcutaneous or intravenous routes -- invasive treatments which can be difficult to tolerate and/or require complicated maintenance. Now, with Ventavis, PAH patients can benefit from a non-invasive, inhaled treatment option. In recently released results from the STEP clinical study, the addition of Ventavis to Tracleer® (bosentan) therapy provided statistically significant improvements in several key clinical parameters. Ventavis is currently marketed by Schering AG in several European countries and Australia. CoTherix licensed exclusive rights to develop and commercialize Ventavis in the United States from Schering AG in October 2003 and filed a New Drug Application (NDA) in June 2004. In August 2004, CoTherix's NDA was accepted by the FDA and granted priority review with orphan drug designation.
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. Because of the risk of syncope, 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, this may be a sign of pulmonary venous hypertension. Ventavis has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.
For important additional information concerning the safety and use of Ventavis, please see the prescribing information available at www.4Ventavis.com.
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. CoTherix's Ventavis® (iloprost) Inhalation Solution was approved by the FDA in December 2004 for the treatment of pulmonary arterial hypertension, 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 is an inhaled formulation of iloprost, a synthetic compound that is structurally similar to prostacyclins. CoTherix and the CoTherix logo are trademarks of CoTherix, Inc. Ventavis is a trademark of Schering AG, Germany. More information can be found at www.cotherix.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 our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the utility of Ventavis for PH associated with IPF. All forward-looking statements included in this press release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. We can not guarantee that any product candidate, including expanding the indication of Ventavis for PH associated with IPF,, will receive FDA or other regulatory approval or that we will seek any such approval. Factors that could cause or contribute to such differences include, but are not limited to, factors discussed in the "Risk Factors and Other Uncertainties" section of our 10-Q filed on May 16, 2005.
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Source: CoTherix, Inc.
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