Barb73 Posted April 24, 2008 Share Posted April 24, 2008 http://www.medicalnewstoday.com/articles/105127.php Excerpt from Press Release: . . . . . . . . . Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced that final efficacy results from its Phase 2 clinical trial of picoplatin confirming previously announced interim results showing a survival benefit in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. The median overall survival rate was 27 weeks and both this efficacy and the safety profile compares favorably with current medical treatments which often include palliative best supportive care. Best supportive care has been shown previously to have a median overall survival of 14 weeks and is the comparator arm for the ongoing randomized Phase 3 trial to evaluate picoplatin treatment in this patient setting. The final data were presented during a poster discussion session at the 1st European Lung Cancer (IASLC) and the European Society for Medical Oncology (ESMO). "These final Phase 2 data show that picoplatin extended survival in patients with small cell lung cancer refractory to, or relapsing within 6 months of first-line platinum based chemotherapy," said Robert De Jager, M.D., chief medical officer of Poniard. "Based on promising results from this trial, we initiated our ongoing Phase 3 SPEAR trial in small cell lung cancer. We are targeting commercialization of picoplatin for use in SCLC in 2010. We are committed to developing picoplatin as a new generation chemotherapy agent addressing multiple indications, combinations and formulations." Final results from patients in the international, open-label, multi-center Phase 2 trial were presented. An analysis of 62 deaths in 77 patients indicated a median overall survival of 27 weeks following picoplatin treatment administered once every 3 weeks. The most common side effects found in this present study were hematologic, including thrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment- related deaths occurred in this study. In addition, quality of life was preserved in the group of patients receiving picoplatin assessed every 3 weeks with Lung Cancer Symptom Scale (LCSS). About Picoplatin Picoplatin is a chemotherapeutic agent that has an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumors. Picoplatin has been evaluated in more than 750 patients and has anti-tumor activity in multiple indications with less severe kidney and nerve toxicity than is commonly observed with other platinum chemotherapy drugs. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial currently is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials for the treatment of hormone-refractory prostate cancer and metastatic colorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. Picoplatin has not been approved by any regulatory authority for use in humans. . . . . . . . . . (Medical News Today, April 24, 2008 [Contains Forward-looking Statements]) Disclaimer: The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind. Quote Link to comment Share on other sites More sharing options...
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