Promedior : Clinical Data for PRM-151 (rhPTX-2) in Idiopathic Pulmonary Fibrosis at American Thoracic Society 2011

May 16, 2011 - Data Highlights Safety and Biomarker Activity in Patients with IPF – Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, presented data from a clinical study of PRM-151 (recombinant human Pentraxin-2 (PTX-2)) at the 2011 American Thoracic Society International Conference (ATS 2011). The poster presentation entitled ”The Effects Of Recombinant Human Pentraxin-2, (PRM-151), On Circulating Fibrocytes In Idiopathic Pulmonary Fibrosis (IPF)” included clinical data from a completed Phase 1 study of PRM-151 that evaluated comprehensive safety endpoints and exploratory biomarker activity in healthy subjects and IPF patients. Across all study participants, PRM-151 was shown to be generally safe and well tolerated; and in a subset of study participants with IPF, PRM-151 showed activity against efficacy biomarkers through reductions in IPF-related blood fibrocytes levels and serum IL-6 levels.

"We are excited to present data from this clinical study, which underscore the potential of PRM-151 as a novel and powerful first-in-class agent to treat IPF, one of the most serious and difficult-to-treat fibrotic diseases... Promedior's Press Release -

Pfizer : The European Commission Approves Pfizer’s Revatio® (sildenafil) for the Treatment of Pulmonary Arterial Hypertension in Children

May 05, 2011 - New Indication Specifically for use in Pediatric Patients Based on Largest Placebo-Controlled Study Conducted in this Population - Pfizer Inc. announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

“Pulmonary arterial hypertension is a rare, devastating disease that can affect children," said Dr. Cara Cassino, vice president, Pfizer Medicines Development Group. “With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition. This approval is another example of our ongoing commitment to rare diseases.”

The approval was based on results of a dose-ranging phase 3 study that evaluated the efficacy and safety of Revatio versus placebo in 234 pediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) following 16 weeks of treatment. In children who were deemed developmentally unable to perform the test due to young age or the presence of other conditions, efficacy was assessed using secondary endpoints, including hemodynamics and change in WHO functional class... Pfizer's Press Release -