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| Bayer Reports Progress in Clinical Program for Riociguat
Positive Phase II Findings Reported at European Respiratory Society Meeting / Phase III Studies to Begin in 2008 | |||
| 6 Oct 2008
, Berlin, Germany
: Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension. Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008. Top-line findings from the open-label, uncontrolled Phase II study were presented today during a Bayer Schering Pharma satellite symposium at the Annual Congress of the European Respiratory Society (ERS) in Berlin, Germany. In addition to significantly increased exercise capacity, patients improved as well in terms of hemodynamic parameters such as pulmonary vascular resistance, cardiac output and pulmonary arterial pressure in comparison to baseline values. The study also showed that riociguat was well tolerated and had a favorable safety profile. Further data from the study are planned to be presented at the American Thoracic Society (ATS) International Conference in May 2009, in San Diego, California, USA. “Riociguat has the potential to overcome limitations of current standards of care in pulmonary hypertension,” said Kemal Malik, M.D., Head of Global Development and Member of the Executive Committee of Bayer HealthCare. “We are expanding into areas of high unmet medical need and riociguat is an example of the kind of novel approach to treating cardiovascular disease to which Bayer is committed.” “Pulmonary hypertension is a life threatening disease and the majority of patients are still left without a viable treatment option,” said lead investigator Prof. Hossein Ardeschir Ghofrani, Head of the Pulmonary Hypertension Division, Department of Internal Medicine, University of Giessen, Germany. “We are very encouraged by the beneficial effects of riociguat in our study. If these findings are replicated in the upcoming Phase III trials, it will be good news indeed for patients with pulmonary hypertension and the physicians who treat them.” In addition to the completed Phase II study and the two Phase III trials in CTEPH and PAH about to begin, further Phase II studies of riociguat are underway in patients suffering from other forms of pulmonary hypertension (PH) such as PH in patients with interstitial lung disease (PH-ILD) or PH in patients with chronic obstructive pulmonary disease (PH-COPD). First results from these studies are currently expected for 2011 and 2009, respectively. About Bayer Schering Pharma The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com. Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de. |
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