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news.Poniard Pharmaceuticals (Poniard) has reported final data from a randomised, controlled phase 2 trial of Picoplatin in metastatic colorectal cancer (CRC) patients. The study met its primary objective.
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In the study, Picoplatin, in combination with 5-fluorouracil and leucovorin (FOLPI regimen), was associated with a reduction in neurotoxicity compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin (FOLFOX regimen).
The study results suggested that FOLPI had similar efficacy to FOLFOX as measured by, disease control of 75% and 76% for FOLPI and FOLFOX, respectively. Six-month and one-year survival rates were 80% and 52% for FOLPI and 83% and 55% for FOLFOX, respectively.
Jerry McMahon, chairman and CEO of Poniard, said: “We believe that these Phase 2 data confirm Picoplatin’s potential as an alternative to oxaliplatin in the first-line treatment of metastatic CRC and will support the design of a Phase 3 study.
“We plan to schedule an end of Phase 2 meeting with the FDA to discuss these data and a potential registration strategy for picoplatin in CRC. Our ultimate goal is to secure a strategic partnership to support further development of picoplatin in CRC and other solid tumor indications, including prostate and ovarian cancers.”
The Picoplatin phase 2 CRC data were presented at the American Society of Clinical Oncology’s 2010 Gastrointestinal Cancers Symposium in Orlando, Florida.