SOUTH SAN FRANCISCO, Calif., May 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced that the independent Data Monitoring Committee (DMC), after review of available information regarding the efficacy, safety and quality of trial conduct, recommends that the SPEAR (Study of Picoplatin Efficacy After Relapse) trial continue. The international, pivotal Phase 3 trial is evaluating the efficacy and safety of picoplatin in patients with small cell lung cancer (SCLC) who were refractory to or progressed within six months of first-line therapy.
"The recommendation by the DMC to continue our SCLC registration trial represents another milestone in the development of picoplatin as a potential new treatment option for SCLC patients," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We are encouraged by the continued progress of the trial and remain on track to complete the clinical data analysis to support the initiation of a New Drug Application with the U.S. Food and Drug Administration this year."
About the Independent DMC
The DMC is an independent, multi-disciplinary group consisting of clinicians and a biostatistician that, collectively, have experience in the management of patients with SCLC and in the conduct and monitoring of randomized clinical trials. The DMC is responsible for safeguarding the interests of the SPEAR trial participants, assessing the safety and efficacy of the interventions during the trial, and for monitoring the overall conduct of the clinical trial. To contribute to enhancing the integrity of the trial, the DMC will also review whether Best Supportive Care (BSC) is qualitatively or quantitatively adequate or inadequate within and between the treatment arms.
Phase 3 SPEAR Trial Design and Special Protocol Assessment
|SOURCE Poniard Pharmaceuticals, Inc.|
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