Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today 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 5-fluorouracil and leucovorin in the FOLPI regimen, has comparable efficacy to oxaliplatin, given in combination with 5-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.
New data for both clinical trials were presented today in poster sessions during the AACR-NCI-EORTC's "Molecular Targets and Cancer Therapeutics" International Conference in Boston. Picoplatin is a new generation platinum-based chemotherapy agent and the Company's lead product candidate in development.
"Our updated proof-of-concept Phase 2 safety and efficacy results continue to suggest that picoplatin could be superior to oxaliplatin as a neuropathy-sparing alternative when used in combination as a first-line treatment for metastatic colorectal cancer. We are continuing follow-up on patients to obtain median overall survival data to facilitate an end of Phase 2 meeting with the U.S. Food and Drug Administration," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Based on the current data in colorectal cancer, as well as encouraging efficacy and safety data from more than 1,100 cancer patients treated with picoplatin in clinical trials, including the cardiac safety trial data presented today, we are continuing discussions with potential partners."
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