after three months of therapy or sooner if significant neurotoxicity
develops (Grade 3 or greater). Nephrotoxicities and ototoxicities
were rare and mild.
Based on this promising data, in November 2007 we initiated a
randomized, Phase 2 study comparing picoplatin to oxaliplatin, both
in combination with 5-fluorouracil and leucovorin. We announced
today that we completed the Phase 2 enrollment. This randomized,
controlled 100-patient trial is designed to compare the safety and
efficacy of picoplatin given once every four weeks in combination
with full-dose 5-fluorouracil and leucovorin dosing in the FOLPI
regimen to oxaliplatin in combination with 5-fluorouracil and
leucovorin in the modified FOLFOX-6 regimen.
We currently are on track to generate data from this trial
throughout 2008 and beyond, and will be presenting early Phase 2 and
updated Phase 1 data at ASCO in June this year.
* Prostate Cancer: At the February 2008 ASCO Genitourinary Cancers
Symposium, we reported encouraging safety and efficacy data from our
Phase 1 dose-escalation study of picoplatin in combination with
docetaxel and prednisone in patients with hormone refractory
prostate cancer (HRPC). Picoplatin was safely administered in
combination with full-dose docetaxel and prednisone, the current
standard of care for first-line HRPC patients. The follow-up Phase 2
study completed enrollment late 2007 and we plan to present data
from this study at ASCO this June and at other scientific meetings.
* Oral Picoplatin: In April this year, results were presented from the
ongoing Phase 1 clinical trial of oral picoplatin in patients with
advanced solid tumor malignancies at the Annual Mee
|SOURCE Poniard Pharmaceuticals, Inc.|
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