Poniard Pharmaceuticals Initiates Randomized Phase 2 Trial of Picoplatin for First-Line Treatment of Metastatic Colorec...( - Phase 1 CRC Data Support Picopla...),Health

- Phase 1 CRC Data Support Picoplatin's Lack of Neuropathy and Use in

Combination Therapy -

SOUTH SAN FRANCISCO, Calif., Nov. 1 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced initiation of a randomized Phase 2 trial to evaluate intravenous picoplatin for first-line treatment of metastatic colorectal cancer (CRC). The objective of this trial is to generate proof-of-concept data to evaluate the efficacy and safety, including neuropathy, of picoplatin in combination with 5- FU and leucovorin, FOLPI versus FOLFOX, and to provide support for a Phase 3 trial. 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.

"This Phase 2 trial supports our strategy to broadly develop picoplatin for a variety of solid tumor indications," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Based on the encouraging safety data we have seen in our Phase 1 trial in colorectal cancer to date, we are initiating this Phase 2 trial to evaluate the efficacy of picoplatin as a first-line chemotherapeutic agent with a potentially more favorable toxicity profile than currently marketed platinums. If the Phase 2 results are positive, we expect to explore advancement to a Phase 3 registrational trial for CRC."

Interim safety results from Poniard's Phase 1 trial in CRC, which was designed to identify the maximum tolerated dose of picoplatin administered every two or four weeks with 5-fluorouracil and leucovorin (the FOLPI regimen), confirmed that this combina
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