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Poniard Pharmaceuticals Announces Picoplatin Safety Data in Colorectal Cancer
Date:1/27/2008

d LV with oxaliplatin) after three months of therapy or sooner if significant (Grade 3 or greater) neurotoxicity develops. For more information, please see http://www.nccn.org.

In the Phase 1 study, 50 patients were treated with picoplatin on either an every-two-week or an every-four-week basis in combination with the standard of care every-two-week dose of 5FU and LV. Patients received up to 28 cycles, and the therapy was well tolerated. Increased hematological toxicity was observed at higher doses. None of the patients treated with picoplatin exhibited a Grade 3 or higher neuropathy and only 9 of 45 patients (20 percent) experienced mild neuropathy. No neuropathy of Grade 2 or greater was observed in the 26 patients who received greater than or equal to 400 mg/m squared picoplatin. Mild nephro- and oto- toxicity were observed infrequently. The dose limiting toxicity (DLT) was most frequently hematological with neutropenia and thrombocytopenia. The maximum tolerated dose was established in the every-four-week schedule at 150 mg/m squared. The maximum tolerated dose for the every-two-week schedule has not yet been reached.

Based on the evidence of a more attractive safety profile of picoplatin in this combination (FOLPI) compared to the standard of care regimen with oxaliplatin (FOLFOX) as well as clinical activity in the Phase 1 study, the Company initiated a randomized Phase 2 trial in November, 2007 to evaluate intravenous picoplatin in the first-line treatment of mCRC. The Phase 2 trial is intended to generate proof-of-concept data to further evaluate efficacy and safety, including neuropathy of picoplatin in combination with 5-FU and LV (FOLPI versus FOLFOX) and to provide support for a potential registrational Phase 3 trial. The Company expects to present data from the Phase 1 and 2 mCRC program in scientific forums around mid year.

About Picoplatin

Picoplatin is an intravenous chemoth
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SOURCE Poniard Pharmaceuticals, Inc.
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