Tracleer and PPH News
Ventavis Scrutinized for IPF-Related Pulmonary Hypertension
by John C. Martin
07-07-05 - A medication already approved as a therapy for people with pulmonary hypertension (PH) is about to enter a second round of clinical testing to determine if it's safe for those with PH related to another lung disease known as idiopathic pulmonary fibrosis, or IPF.
Expanded Role Possible
CoTherix, the maker of Ventavis (iloprost) Inhalation Solution, announced in early June that it has initiated a Phase 2 clinical trial to test the drug in a group of patients with the two illnesses. "Ventavis is an ideal candidate to investigate for IPF patients with pulmonary hypertension," said James Pennington, MD, Executive Vice-President and Chief Medical Officer of CoTherix. "Since Ventavis is inhaled, we believe it targets only the non-fibrotic portions of the diseased lung, increasing [blood vessel dilation] only in the ventilated areas, and reducing the potential for mismatched ventilation and pulmonary bloodflow, which can lead to heart strain and fainting."
The primary objective of the double-blind, placebo-controlled clinical trial, called ACTIVE, will be to determine the safety of Ventavis in patients with PH who also have been diagnosed with mild to moderate idiopathic pulmonary fibrosis. Included in the study will be the standard 6-minute walk test, which determines how far a particular patient can walk in a given time period; and any changes in disease progression or blood circulation.
The study will involve about 50 patients at 15 sites in the United States, CoTherix stated.
Progressive Scarring Disease
Idiopathic pulmonary fibrosis is a disease characterized by progressive scarring of the lungs that gradually complicates breathing. When it reaches that point, the disease prevents organs from obtaining levels of oxygen that keep them functioning. IPF is one of 200 diseases that fall into a class known as interstitial lung disease (ILD), in which lung scarring is a key manifestation.
While IPF can be linked in some cases to certain causes like exposure to inorganic or organic dusts, chemotherapy or radiation therapy, lung infection, or certain connective tissue diseases, in most cases, it has no known cause.
It's estimated that approximately 83,000 people in the United States have IPF, and an estimated 31,000 new cases develop each year. The disease typically strikes between the ages of 50 and 70, and tends to affect men more than women. The key symptoms are shortness of breath and a dry cough.1 According to CoTherix, the average odds of survival for patients with the disease is approximately 4 to 6 years after diagnosis.
Pulmonary hypertension, in which the blood pressure in the pulmonary artery leading from the heart to the lungs rises to abnormal levels, can be a serious complication of IPF.2 It's estimated that about one-fifth of IPF patients also have been diagnosed with pulmonary hypertension.
'Limited' Therapy Choices
"Treatment options for these patients are extremely limited," said Richard Channick, MD, an associate professor of Medicine at the University of California, San Diego, an expert on pulmonary hypertension and its treatment who will be taking part in the upcoming clinical trial. "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."
If approved, Ventavis would become the first available medication to treat PH associated with IPF. It was initially approved as a PH medication late last year.
1. Coalition for Pulmonary Fibrosis. What is IPF? Some Basic Facts. Available at: http://www.coalitionforpf.org/Patients/whatisipf.asp. Accessed July 7, 2005.
2. Olschewski H, Ghofrani HA, Walmrath D et al. Inhaled prostacyclin and iloprost in severe pulmonary hypertension secondary to lung fibrosis. Am J Respir Crit Care Med 1999 Aug;160(2):600-7.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
Encysive Pharmaceuticals Announces Presentation of New STRIDE-2X Data at EULAR Congress
HOUSTON, June 22 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY) today announced the presentation of new STRIDE-2X data evaluating Thelin(TM) (sitaxsentan sodium) in pulmonary arterial hypertension (PAH) at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Amsterdam, The Netherlands. STRIDE-2X is the open-label, one-year extension study for the Company's 18-week placebo- controlled Phase III pivotal trial, STRIDE-2.
Data from a subset analysis, entitled, "Comparison of Sitaxentan and Bosentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Diseases (CTD)," (Abstract FRI0354) will be presented by Kristin B. Highland, M.D., Assistant Professor, Division of Pulmonary, Critical Care, Allergy, and Clinical Immunology at the Medical University of South Carolina on Friday, June 23, during a poster session beginning at 12:15 p.m. CEST.
A second Thelin abstract, entitled, "Sitaxsentan, A Selective Endothelin-A Receptor Antagonist, Improves Exercise Capacity in PAH Associated with CTD," (J.R. Siebold, M.D., et al.; Abstract SAT0233) will be presented during a poster session on Saturday, June 24 from 8:15 a.m. - 9:45 a.m. CEST. To view the Thelin abstracts, and for more information about EULAR and the 2006 European Congress of Rheumatology, please visit http://www.eular.org/ .
The New Drug Application for Thelin (sitaxsentan sodium) 100 mg tablets is currently being evaluated by the U.S. Food and Drug Administration (FDA) as a potential new oral treatment for patients with pulmonary arterial hypertension, with a PDUFA date of July 24, 2006. On June 2, the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) delivered a positive opinion recommending the approval of Thelin 100 mg tablets. A final decision for European approval is expected within 90 days of the CHMP opinion announcement.
"Sitaxentan" sodium is the spelling recognized by the World Health Organization for Encysive Pharmaceuticals' sitaxsentan sodium.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com .
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are decisions by the U.S. Food and Drug Administration and other regulatory authorities regarding whether and when to approve our drug applications for Thelin(TM) (sitaxsentan sodium), as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.
SOURCE Encysive Pharmaceuticals Inc.
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