MONTREAL, Oct. 31 /PRNewswire-FirstCall/ -- CoTherix, Inc. today announced newly-presented data from a Phase II randomized clinical study designed to evaluate the safety and pilot efficacy of adding Ventavis(R) (iloprost) Inhalation Solution to stable doses of Tracleer(R) (bosentan) in patients with pulmonary arterial hypertension (PAH). These data from the Company’s STEP Trial (acronym for: iloprost inhalation solution Safety and pilot efficacy Trial in combination with bosentan for Evaluation in Pulmonary arterial hypertension) were presented at the American College of Chest Physicians meeting (CHEST) in Montreal.
The data showed that the addition of Ventavis to Tracleer resulted in similar safety trends to those seen in the larger experience of the Phase III study with Ventavis. In addition, data from the secondary endpoints in the STEP study showed an improvement in the 6 minute walk exercise test (p=0.051) and New York Heart Association functional class (p=0.002), a reduction in mean pulmonary artery pressure (p<0.0001) and a delay in clinical deterioration (p=0.022). Clinical deterioration is defined as any of the following: death due to worsening PAH (mortality), receipt of lung transplant or atrial septostomy, hospitalization for worsening PAH, or any early discontinuation from study drug due to worsening PAH).
The data were presented today in an oral presentation by Vallerie McLaughlin, M.D., Associate Professor of Medicine and Director of the Pulmonary Hypertension Program, University of Michigan.
“Combination therapy has become an area of increased interest for the PAH community, and patients in this study who received inhaled iloprost on top of oral bosentan not only tolerated the combination, but experienced enhanced treatment efficacy,” said Vallerie McLaughlin, MD. “Of particular note, combination patients in the study treated with iloprost plus bosentan had a statistically significant improvement in their delay in time to clinical worsening when compared to those treated with therapy of bosentan alone. This important result suggests that this combination treatment strategy may slow the rate of the disease progression.”
“Combination drug therapy for patients with PAH is an important area of interest for CoTherix and we will continue to conduct rigorous, double-blind, placebo-controlled clinical studies to explore the safety and added benefit of Ventavis combined with other products with potentially complementary mechanisms of action,” said James Pennington, M.D., Executive Vice President and Chief Medical Officer of CoTherix, Inc. “As evidence of this strategy, we intend to initiate a trial in the first half of 2006 to study the effects of adding Ventavis treatment to patients receiving sildenafil.”
STEP Trial investigators have submitted the data for publication in a peer-reviewed journal. For more information on Ventavis visit booth #1414.
About the STEP Trial
The STEP Trial was a Phase II double-blind, placebo-controlled trial, in which PAH patients treated with Tracleer, an oral endothelin receptor antagonist, were randomized to receive either Ventavis (inhaled iloprost) or inhaled placebo in combination with Tracleer for 12 weeks. Fifteen U.S. clinical sites enrolled 65 patients into the intent-to-treat analysis population (32 Ventavis and 33 placebo). Baseline characteristics were well- balanced across the two arms. Compliance with scheduled doses was over 90% in each arm, with the majority of patients taking six inhalations per day.
About Ventavis
Ventavis(R) (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 that can lead to infections and require complicated maintenance. Now, with Ventavis, PAH patients can benefit from a non-invasive, inhaled treatment option.
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.
For important additional information concerning the safety and use of Ventavis, please see the prescribing information available at www.4Ventavis.com .
About PAH
PAH affects an estimated 50,000 patients in the United States, with only about 15,000 diagnosed and under treatment. Its cause may be unknown, or result from other diseases that cause a restriction of blood flow to the lungs, including scleroderma, HIV and lupus. Symptoms of the disease include fatigue, shortness of breath on exertion, chest pain and dizziness. Left untreated, the median survival time following diagnosis may be as short as three years.
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(R) (iloprost) Inhalation Solution was approved by the FDA in December 2004 for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class III or IV symptoms. PAH is a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs. 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 and 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 our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding any suggestion or inference that may be drawn from the STEP study results, the potential of combination treatment generally and whether it may slow the rate of disease progression, our strategy to continue to conduct clinical studies and the nature of those studies, the anticipated study of Ventavis and sildenafil and its projected initiation date, and the ability of patients to benefit from Ventavis. In addition, the results of the STEP Trial or any other clinical trials do not necessarily predict the results of later stage clinical trials. Data collected from clinical studies are subject to varying interpretation, and may be deemed insufficient by the FDA or other regulatory bodies reviewing applications for market approval or label expansion (including combination therapy) of any product or product candidate. We cannot guarantee that any product candidate, including any combination therapy, will receive FDA or other regulatory approval or that we will seek any such approval. 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. Actual results, and other events, could differ materially from our current expectations. Factors that could cause or contribute to such differences include, but are not limited to, factors described from time to time in our filings with the Securities and Exchange Commission, including those discussed in the “Risk Factors” section of our Registration Statement on Form S-1, filed on October 6, 2005.
CoTherix, Inc.
CONTACT: investors and media, Anne Bowdidge, Senior Director of InvestorRelations of CoTherix, Inc., +1-650-808-6551