SOUTH SAN FRANCISCO, Calif., Oct. 17 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that its lead product candidate, picoplatin, has been granted orphan medicinal product designation for the treatment of small cell lung cancer (SCLC) by the European Commission. This designation is based on a recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA).
Picoplatin is currently being studied in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in SCLC, which is evaluating overall survival as the primary endpoint and is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
"The receipt of orphan drug designation in the EU for picoplatin for the treatment of small cell lung cancer is an important achievement and builds on our success of obtaining orphan drug designation for picoplatin in the U.S.," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Because many SCLC patients who are treated with platinum therapies relapse quickly or do not respond at all, new therapies that are active in this disease and that can overcome platinum resistance are urgently needed. We are committed to bringing picoplatin to market in the U.S. and the EU for this severely underserved patient population and are making significant progress in enrolling patients in our pivotal SPEAR trial for this indication."
About Orphan Drug Designation in the European Union
The EU orphan medicinal product designation aims to encourage the
development of drugs involved in the diagnosis, prevention or treatment of
a life-threatening or chr
|SOURCE Poniard Pharmaceuticals, Inc.|
Copyright©2007 PR Newswire.
All rights reserved