Poniard Pharmaceuticals, Inc. has announced that it has completed patient enrollment in its Phase 2 clinical trial evaluating picoplatin combination chemotherapy for the first-line treatment of metastatic colorectal cancer (CRC). Early data from this trial are expected in the second half of 2008.
Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.
"Picoplatin, to date, has demonstrated good tolerability, with no severe neuropathies when combined with 5-fluorouracil and leucovorin in the FOLPI regimen. In our Phase 2 trial, we are performing a head-to-head comparison of the efficacy and safety of picoplatin with oxaliplatin. We will be presenting preliminary Phase 2 data and updated Phase 1 data at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting, and we anticipate more clinical data this year for presentations at various scientific meetings," said Robert De Jager, M.D., chief medical officer of Poniard.
"The data from our ongoing Phase 2 trial could establish picoplatin as a platform product and provide a solid foundation for supporting additional registration trials, thereby expanding the potential of this product."
Poniard explains that 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 demonstrated anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs.