Poniard Pharmaceuticals Receives Chinese State FDA Approval for Clinical Development of Picoplatin
Product News Mar 03, 2011
Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, has announced that it has received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to conduct two Phase III clinical studies of its lead product candidate, picoplatin, in the treatment of second-line small cell lung cancer (SCLC) and second-line ovarian cancer in the People's Republic of China.
The approval of both Phase III protocols by SFDA allows for the inclusion of Chinese clinical sites in developing and executing global registration trials within these disease settings. Picoplatin has demonstrated promising clinical activity in both SCLC and ovarian cancer.
The Company is currently exploring strategic alternatives aimed at optimizing shareholder value and expects that CTA approval will provide additional flexibility with respect to potential picoplatin development opportunities.
"We believe that CTA approval from the SFDA enhances picoplatin's value proposition to potential partners in two important disease settings in which picoplatin has demonstrated strong clinical potential," said Ronald A. Martell, chief executive officer of Poniard Pharmaceuticals. "This milestone, in addition to two recent draw downs totaling $3.4 million under our equity financing facility, will help provide additional leverage as we work to complete our strategic review."