Poniard Pharmaceuticals Announces 2010 Goals for Picoplatin
07 Januar 2010 - 2:00PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., Jan. 7 /PRNewswire-FirstCall/ --
Poniard Pharmaceuticals, Inc. (NASDAQ:PARD) today provided an
overview of its 2010 corporate, clinical and regulatory goals for
picoplatin. "Our focus in 2010 is to secure a strategic partnership
to continue the development of picoplatin as a preferred platinum
agent in the treatment of solid tumor malignancies. We believe that
current data from approximately 1,100 patients treated with
picoplatin, including data from Phase 2 trials of picoplatin in
colorectal, prostate and ovarian cancers, indicate that picoplatin
would be a valuable addition to potential partners with marketed
and development stage oncology products," said Jerry McMahon,
Ph.D., chairman and chief executive officer of Poniard. "Throughout
the first half of this year, we plan to a have discussions with the
U.S. Food and Drug Administration regarding a regulatory path
forward for picoplatin in small cell lung cancer. We expect to
submit efficacy and safety data from the Phase 3 SPEAR trial for
potential presentation at the American Society of Clinical Oncology
2010 Annual Meeting in June." Poniard plans to work toward the
achievement of the following goals for picoplatin in 2010:
Picoplatin for the Treatment of Small Cell Lung Cancer * Complete
discussions with the U.S. Food and Drug Administration (FDA)
regarding a regulatory path forward for picoplatin in small cell
lung cancer (SCLC). The Phase 3 SPEAR (Study of Picoplatin Efficacy
After Relapse) trial enrolled 401 patients and evaluated
intravenous picoplatin in SCLC patients who failed or relapsed
following first-line platinum therapy within six months following
initial treatment with a platinum-based therapy. While the data
analysis showed that the study did not meet the primary endpoint of
overall survival, the data suggest a potential trend toward a
survival advantage in SCLC patients treated with picoplatin and
best supportive care compared to best supportive care alone. The
intent-to-treat analysis was based on 321 patient deaths and showed
a hazard ratio of 0.82 and a p value of 0.089. * Submit SPEAR
efficacy and safety data for potential presentation at the American
Society of Clinical Oncology (ASCO) 2010 Annual Meeting taking
place June 4-8, 2010 in Chicago. Picoplatin for the Treatment of
Colorectal Cancer * Present additional data from the Company's
Phase 2 trial evaluating picoplatin as a neuropathy-sparing agent
compared to oxaliplatin in the first-line treatment of patients
with metastatic colorectal cancer (CRC) on Sunday, January 24, 2010
at the ASCO 2010 Gastrointestinal Cancers Symposium in Orlando,
Fla. This randomized, controlled trial is being conducted with 101
metastatic CRC patients who have not received prior chemotherapy
and is comparing the safety, including the incidence and severity
of neuropathy, and efficacy, measured by overall survival,
progression-free survival and disease control, of intravenous
picoplatin in combination with 5-fluorouracil and leucovorin (the
FOLPI regimen) to oxaliplatin given in combination with 5-
fluorouracil and leucovorin in the modified FOLFOX-6 regimen. Data
to date have shown a statistically significant reduction in
neurotoxicities with the use of picoplatin in the FOLPI regimen
compared with the use of oxaliplatin in the FOLFOX regimen (p