Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a specialty pharmaceutical company
focused on oncology, today announced that it has received a Special
Protocol Assessment (SPA) agreement from the U.S. Food and Drug
Administration (FDA) for its pivotal Phase 3 SPEAR (Study of Picoplatin
Efficacy After Relapse) trial of picoplatin for the treatment of small cell
lung cancer (SCLC).
Picoplatin, the Company's lead product candidate, is a new generation
platinum therapy with an improved safety profile. It is designed to
overcome and prevent platinum resistance associated with chemotherapy in
solid tumors. Poniard received orphan drug designation in November 2005
from the FDA for picoplatin for the treatment of SCLC.
"This SPA agreement with the FDA solidifies our plan to conduct a
single pivotal Phase 3 trial that evaluates overall survival as the primary
endpoint in order to rapidly achieve U.S. approval for picoplatin for the
treatment of patients with small cell lung cancer who currently are
severely underserved," said Jerry McMahon, Ph.D., chairman, president and
CEO of Poniard.
Based on the positive interim median overall survival data from
Poniard's ongoing Phase 2 clinical trial of picoplatin in patients with
SCLC announced last month, the Company plans to initiate the SPEAR trial in
the first half of 2007. The primary endpoint of this pivotal Phase 3
international, multi-center, randomized trial will be overall survival.
Overall response rates, progression-free survival and disease control also
will be evaluated. The Company expects to enroll approximately 400 patients
in the trial, which is expected to take about 20 months to complete
enrollment and follow up. The trial will have a 2:1 randomization comparing
picoplatin plus best supportive care to best supportive care alone, and
will include patients who are refractory to, or who have progressed within
six months of completing, treatment with first-line platinum chemotherapy
(cisplatin or carboplatin). The Company expects to file a New Drug
Application for the SCLC indication in 2009.
Interim Phase 2 Survival Results
In November 2006, Poniard announced interim median overall survival
data from its ongoing open-label, multi-center, Phase 2 clinical trial.
This ongoing trial is designed to confirm the clinical activity of
picoplatin as second-line therapy in SCLC patients with platinum-refractory
disease or disease that has progressed within six months following
first-line treatment with a platinum-based chemotherapy, such as cisplatin
or carboplatin. Overall response rates, progression-free survival,
improvement in disease-related symptoms and disease control are being
evaluated in addition to overall survival.
An interim analysis showed a median overall survival of 26.7 weeks in
the 72 evaluable patients treated with picoplatin. According to the 2006
National Comprehensive Cancer Network practice guidelines, the median
survival for patients who receive second-line chemotherapy is approximately
16 to 20 weeks. At the time of the interim analysis, there had been 22
deaths from disease progression among the 77 picoplatin-treated patients.
Although there were not sufficient data on the last five patients enrolled
in the Phase 2 study to include them in the interim analysis, data for all
patients will be included in the final analysis. Final results are expected
in mid-2007 and will be submitted for presentation at upcoming scientific
conferences.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on the discovery, development and commercialization of innovative
oncology products to impact the lives of people with cancer. Picoplatin,
the Company's lead product candidate, is a new generation platinum therapy
with an improved safety profile. An intravenous chemotherapeutic agent, it
is designed to overcome and prevent platinum resistance associated with
chemotherapy in solid tumors. Picoplatin is currently being studied in
clinical trials for the treatment of small cell lung, colorectal and
hormone-refractory prostate cancers. As part of the Company's strategic
goal of building a diverse oncology pipeline, the Company also is
collaborating with the Scripps Florida Research Institute on the discovery
of novel, small-molecule, multi-targeted protein kinase inhibitors. For
additional information please visit poniard.
This release contains forward-looking statements, including statements
regarding the Company's business model, drug development program and
clinical trial plans and preliminary results to date. The Company's actual
results may differ materially from those indicated in these forward looking
statements based on a number of factors, including anticipated operating
losses, uncertainties associated with research, development, clinical
trials, the results of later clinical testing and related regulatory
approvals, future capital needs and uncertainty of additional financing,
competition, uncertainties associated with intellectual property,
dependence on third-party manufacturers, suppliers and collaborators, lack
of sales and marketing experience, loss of key personnel, uncertainties
associated with market acceptance, technology change and government
regulation, general market conditions and the other risks and uncertainties
described in the Company's current and periodic reports filed with the
Securities and Exchange Commission, including the Company's Annual Report
on Form 10-K for the year ended December 31, 2005, and its Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006. Readers are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release. The Company undertakes no
obligation to update any forward-looking statement to reflect new
information, events or circumstances after the date of this release or to
reflect the occurrence of unanticipated events.
Poniard Pharmaceuticals, Inc.
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