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Special Protocol Assessment Issued for Phase 3 Trial of New Generation Platinum Therapy
Picoplatin, the Company's lead product candidate, is a new generation platinum therapy with an improved safety profile. It is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. Poniard received orphan drug designation in November 2005 from the FDA for picoplatin for the treatment of SCLC.
"This SPA agreement with the FDA solidifies our plan to conduct a single pivotal Phase 3 trial that evaluates overall survival as the primary endpoint in order to rapidly achieve U.S. approval for picoplatin for the treatment of patients with small cell lung cancer who currently are severely underserved," said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard.
Based on the positive interim median overall survival data from Poniard's ongoing Phase 2 clinical trial of picoplatin in patients with SCLC announced last month, the Company plans to initiate the SPEAR trial in the first half of 2007. The primary endpoint of this pivotal Phase 3 international, multi-center, randomized trial will be overall survival. Overall response rates, progression-free survival and disease control also will be evaluated. The Company expects to enroll approximately 400 patients in the trial, which is expected to take about 20 months to complete enrollment and follow up. The trial will have a 2:1 randomization comparing picoplatin plus best supportive care to best supportive care alone, and will include patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum chemotherapy (cisplatin or carboplatin). The Company expects to file a New Drug Application for the SCLC indication in 2009.
Interim Phase 2 Survival Results
In November 2006, Poniard announced interim median overall survival data from its ongoing open-label, multi-center, Phase 2 clinical trial. This ongoing trial is designed to confirm the clinical activity of picoplatin as second-line therapy in SCLC patients with platinum-refractory disease or disease that has progressed within six months following first-line treatment with a platinum-based chemotherapy, such as cisplatin or carboplatin. Overall response rates, progression-free survival, improvement in disease-related symptoms and disease control are being evaluated in addition to overall survival.
An interim analysis showed a median overall survival of 26.7 weeks in the 72 evaluable patients treated with picoplatin. According to the 2006 National Comprehensive Cancer Network practice guidelines, the median survival for patients who receive second-line chemotherapy is approximately 16 to 20 weeks. At the time of the interim analysis, there had been 22 deaths from disease progression among the 77 picoplatin-treated patients. Although there were not sufficient data on the last five patients enrolled in the Phase 2 study to include them in the interim analysis, data for all patients will be included in the final analysis. Final results are expected in mid-2007 and will be submitted for presentation at upcoming scientific conferences.
Source: Poniard Pharmaceuticals