Poniard Pharmaceuticals Provides Year-End Clinical Update at 2007 Lazard Capital Markets Healthcare ... ( 73 of the approximately 100 clinical si...)

Poniard Pharmaceuticals Provides Year-End Clinical Update at 2007 Lazard Capital Markets Healthcare Conference

Date:11/27/2007

, 73 of the approximately 100 clinical sites in the SPEAR study are active, and the balance of sites is to be opened as planned. Based on recent enrollment data, Poniard estimates that it will complete enrollment in 3Q 2008.

Poniard continues to anticipate filing a New Drug Application with the FDA in 2009. The Company received fast track designation from the FDA for picoplatin for the second-line treatment of refractory or resistant SCLC, allowing a rolling NDA submission.

"We are encouraged by the enrollment pace at our sites that have been open for three months or more, because these are enrolling patients better than at the anticipated rate," added Dr. McMahon. "Based on our prior trial in SCLC, and our experience at many of our active SPEAR sites, we anticipate an acceleration of enrollment as more sites are open longer and new sites are opened. In addition to patients that have already enrolled, we are following approximately 200 additional SCLC patients currently receiving first-line treatment who may be eligible to participate in the SPEAR trial."

Phase 2 CRC Trial:

Poniard is also evaluating intravenous picoplatin as a replacement for oxaliplatin in an ongoing Phase 2 trial for the first-line treatment of metastatic CRC with picoplatin in combination with 5-fluorouracil and leucovorin, or FOLPI, compared to the standard-of-care FOLFOX regimen, including oxaliplatin, in a 100-patient randomized trial.

The Company has opened 18 of the planned 23 clinical sites and is enrolling patients in this randomized trial, which is evaluating picoplatin as a first-line agent in CRC. The Company is treating patients in the trial and expects to fully enroll the trial in the first half of 2008. Poniard expects to present clinical data from the Phase 1 and Phase 2 CRC trials at scientific meetings throughout 2008.

Phase 2 HRPC Trial:

Intravenous picoplatin also is under evaluation in an ongoing Phase 2 trial for the treatment
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SOURCE Poniard Pharmaceuticals
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