Key Developments For Poniard Pharmaceuticals, Inc.
Poniard Pharmaceuticals, Inc. (PARD.O) (Consolidated Issue listed on NASDAQ Global Market)
Poniard Pharmaceuticals, Inc. Announces $7.4 Million Financing
Poniard Pharmaceuticals, Inc. announced that the sale of 3,465,878 of its common shares to Azimuth Opportunity Ltd. for gross proceeds of approximately $7.4 million, or approximately $2.15 per share, under its existing committed equity financing facility with Azimuth. The Company intends to use the $7.3 million in net proceeds from this sale to focus on regulatory and partnering activities for picoplatin, clinical development, other general corporate purposes and working capital. Based on its cash reserves, including the net proceeds from this offering.
Poniard Pharmaceuticals, Inc. Announces Updated Positive Clinical Data From Phase 2 Trial Of Picoplatin In Colorectal Cancer And New Phase 1 Cardiac Safety Trial Results
Poniard Pharmaceuticals, Inc. announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The updated results indicated that picoplatin, given once every four weeks in combination with five fluorouracil and leucovorin in the FOLPI regimen, has comparable efficacy to oxaliplatin, given in combination with five fluorouracil and leucovorin in the modified FOLFOX-6 regimen, as a first-line therapy for CRC, as assessed by one-year survival rate, progression-free survival (PFS) and disease control. The Company also announced new results from its Phase 1 cardiac safety trial, which showed no clinical cardiac-related events, as expected. The randomized, controlled Phase 2 trial is evaluating picoplatin as a neuropathy sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who have not received prior chemotherapy. The trial is comparing the safety and efficacy of intravenous picoplatin given once every four weeks in combination with bi-weekly five fluorouracil and leucovorin (the FOLPI regimen) with oxaliplatin given in combination with 5-fluorouracil and leucovorin in the mFOLFOX-6 regimen.
Poniard Pharmaceuticals, Inc. Announces Pivotal Phase 3 SPEAR Trial Of Picoplatin In Small Cell Lung Cancer Did Not Meet Primary Endpoint
Poniard Pharmaceuticals, Inc. announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089. The international, multi-center, randomized, controlled Phase 3 SPEAR trial was conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The trial evaluated the efficacy and safety of picoplatin as second-line therapy in 401 cancer patients with SCLC who were refractory to or who progressed within six months of first-line platinum-based therapy. Picoplatin administered as an intravenous infusion once every three weeks plus best supportive care (BSC) was compared to BSC alone. BSC was designed in accordance with the National Comprehensive Cancer Network's guidelines. The primary endpoint of the trial was overall survival. Other endpoints included overall response rate, progression-free survival, disease control rate and duration of response. The Statistical Analytical Plan of the trial, as agreed to in the SPA, was 90 percent powered to show a 33 percent reduction in risk in death for picoplatin treatment plus best supportive care (BSC) compared with BSC alone (hazard ratio of 0.67; p value of 0.05).
Poniard Pharmaceuticals, Inc. Announces Pivotal Phase III SPEAR Trial Evaluating Picoplatin In Small Cell Lung Cancer
Poniard Pharmaceuticals, Inc. announced that evaluable events (patient deaths) have occurred in its pivotal Phase III SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which is being conducted in accordance with a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA), evaluating picoplatin in the treatment of small cell lung cancer (SCLC). The international, multi-center, randomized, controlled Phase 3 SPEAR trial is evaluating the efficacy and safety of picoplatin as second-line therapy in 401 cancer patients with SCLC who have not responded to or who relapsed following first-line platinum-based therapy. The primary endpoint of the trial is overall survival. The Statistical Analysis Plan of the trial, as agreed to in the SPA, is 90% powered to show a 33% reduction in risk in overall survival for picoplatin treatment with best supportive care (BSC) compared with BSC alone (hazard ratio of 0.67; p<0.05). The trial completed enrollment in March 2009. The SPEAR trial randomized patients with SCLC who were refractory to prior platinum-containing, first-line chemotherapy regimens or who had progressed within six months of first-line therapy.
Poniard Pharmaceuticals, Inc. Secures $60 Million Committed Equity Financing Facility
Poniard Pharmaceuticals, Inc. announced that it has secured a committed equity financing facility under which it may sell up to $60 million of its registered common stock to Azimuth Opportunity Ltd. over an 18 month period. Poniard is not obligated to utilize any of the $60 million facility and remains free to enter into and consummate other equity and debt financing transactions. Poniard intends to use the proceeds from any future sale of securities under the facility to advance its picoplatin clinical development and commercialization programs, pursue potential new product opportunities and for other general corporate purposes.
