Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer Did Not Meet Primary Endpoint
-- Company to Host Conference Call and Webcast Today at 8:00 a.m. ET --
SOUTH SAN FRANCISCO, Calif., Nov. 16 /PRNewswire-FirstCall/ --
Poniard Pharmaceuticals, Inc. (NASDAQ:PARD) today announced that its pivotal
Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of
picoplatin in the second-line treatment of small cell lung cancer
(SCLC) did not meet its primary endpoint of overall survival. The
analysis, based on 320 evaluable events (patient deaths), showed a
hazard ratio of 0.82 with a p value of 0.089.
"We are disappointed that the trial did not meet the primary
endpoint. The data indicates that more patients on the best
supportive care arm received chemotherapy following progression
than those on the picoplatin arm, and we believe that this may have
been a significant factor contributing to the trial outcome, as
picoplatin appeared to demonstrate a trend toward a survival
advantage. Based on these findings and other analyses, we are
contacting the FDA today to request a meeting to discuss a
regulatory path forward. We look forward to presenting the full
SPEAR efficacy and safety data at an upcoming medical conference
early next year," said Jerry McMahon, Ph.D., chairman and chief
executive officer of Poniard. "We believe that the SPEAR data,
coupled with efficacy and safety data from more than 1,100 cancer
patients treated with picoplatin and the proof-of-concept data from
our trials in colorectal, prostate and ovarian cancers, support our
continued partnering effort. Our focus will be on the regulatory
pathway for picoplatin, partnering activities, and realigning the
use of resources for these objectives."
Conference Call and Webcast Information
Poniard's management team will host a conference call and
Webcast today at 8:00 a.m. Eastern Time/5:00 a.m. Pacific Time to
discuss this announcement. To participate by telephone, please dial
866-816-1982 from the U.S. or 913-312-0857 for international
callers. The Webcast can be accessed on the "Events" page of the
"News & Events" section of the Company's Web site at http://www.poniard.com/. A replay of the Webcast
will be available on the Company's Web site for 10 days.
SPEAR Trial Design
The international, multi-center, randomized, controlled Phase 3
SPEAR trial was conducted under a Special Protocol Assessment (SPA)
with the U.S. Food and Drug Administration (FDA). The trial
evaluated the efficacy and safety of picoplatin as second-line
therapy in 401 cancer patients with SCLC who were refractory to or
who progressed within six months of first-line platinum-based
therapy. Picoplatin administered as an intravenous infusion once
every three weeks plus best supportive care (BSC) was compared to
BSC alone. BSC was designed in accordance with the National
Comprehensive Cancer Network's guidelines. The primary endpoint of
the trial was overall survival. Other endpoints included overall
response rate, progression-free survival, disease control rate and
duration of response. The Statistical Analytical Plan of the trial,
as agreed to in the SPA, was 90 percent powered to show a 33
percent reduction in risk in death for picoplatin treatment plus
best supportive care (BSC) compared with BSC alone (hazard ratio of
0.67; p value of 0.05). Patient enrollment in the trial was
completed in March 2009.
About Picoplatin
Picoplatin is a new and differentiated platinum-based
chemotherapeutic agent that is in clinical development for multiple
cancer indications, treatment combinations and by two routes of
administration. It is designed to overcome platinum resistance
associated with chemotherapy in solid tumors. Study data to date
suggest that picoplatin has an improved safety profile relative to
existing platinum-based cancer therapies. More than 1,100 patients
have received picoplatin. Results obtained to date suggest that
hematologic events are common but manageable. Kidney toxicity
(nephrotoxicity) and nerve toxicity (neurotoxicity) are less
frequent and less severe than is commonly observed with other
platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor
activity in a variety of solid tumors.
In addition to the SPEAR Phase 3 trial in SCLC, Poniard is
evaluating intravenous picoplatin in a Phase 2 clinical trial in
patients with colorectal cancer, in a Phase 2 clinical trial in
patients with castration-resistant prostate cancer, and in a Phase
1 cardiac safety assessment. In addition, final results from a
trial of an oral formulation of picoplatin were presented earlier
this year.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the development and commercialization of innovative
oncology products to impact the lives of people with cancer. For
additional information please visit http://www.poniard.com/.
Forward-Looking Statement
This release contains forward-looking statements, including the
Company's SPEAR and other clinical trial results to date, the
commercial and therapeutic potential of picoplatin, the Company's
regulatory strategy, business plans and prospects, competitive
position and strategic partnering strategy and goals. The Company's
actual results may differ materially from those indicated in these
forward-looking statements based on a number of factors, including
risks and uncertainties inherent in the Company's business,
including, but not limited to, the risk that the Company's
additional analyses of data from clinical trials of picoplatin may
produce negative or inconclusive results, or may be inconsistent
with previously announced results or previously conducted trials;
the results of the Company's discussions with the FDA and other
regulatory authorities; the potential safety and efficacy of the
Company's picoplatin product candidate; the receipt and timing of
any FDA and other required regulatory approvals, if any; if
regulatory approval of any product candidate is received, the
market's acceptance of that product or the occurrence post-approval
problems that may require the withdrawal of picoplatin from the
market; the Company's anticipated operating losses, need for future
capital and ability to obtain future funding; competition from
third parties; the Company's ability to preserve and protect its
intellectual property rights; the Company's dependence on
third-party manufacturers, suppliers and other contractors; the
Company's lack of sales and marketing experience; the Company's
ability to attract and retain key personnel and enter into
strategic partnerships; changes in technology, government
regulation and general market conditions; and the risks and
uncertainties described in the Company's current and periodic
reports filed with the Securities and Exchange Commission (SEC),
including the Company's Annual Report on Form 10-K for the year
ended December 31, 2008, and its Quarterly Report on Form 10-Q for
the period ended September 30, 2009. 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.
(C) 2009 Poniard Pharmaceuticals, Inc. All Rights
Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard
Pharmaceuticals, Inc.
Source: Poniard Pharmaceuticals, Inc.
CONTACT: CONTACT: Investors, Susan Neath, +1-609-529-0676
(mobile),
sneath@wcpglobal.com, or media,
Jani Bergan, +1-415-572-1353 (mobile),
jbergan@wcpglobal.com, both of
WeissComm Partners, for Poniard
Pharmaceuticals, Inc.; or Investors, Rebecca Birbach of Burns
McClellan,
+1-415-350-0303 (mobile), rbirbach@burnsmc.com, for
Poniard Pharmaceuticals,
Inc.
Web Site: http://www.poniard.com/
Posted: November 2009
