Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused
on oncology, announced that updated results of its Phase 2 clinical
trial of picoplatin confirm and extend the previously announced interim
data analysis, which demonstrated a survival benefit in patients with
recurrent small cell lung cancer (SCLC) who have relapsed within six months
of first-line therapy. The company also for the first time announced the
median one-year survival rate of 17.6 percent in the Phase 2 population of
mostly platinum-refractory and -resistant patients studied in this trial.
Picoplatin, the Company's lead product candidate, is currently being
evaluated in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After
Relapse) trial in SCLC, which is being conducted under a Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug Administration
(FDA). The SPEAR trial is being conducted in platinum-refractory,
-resistant, and -sensitive SCLC patients who have failed or relapsed from
initial therapy within six months of initial treatment and is comparing
picoplatin treatment with best supportive care to best supportive care
alone. The median overall survival is approximately 17 to 22 weeks for
patients with recurrent SCLC who are treated with existing second-line
chemotherapies, according to the 2007 National Comprehensive Cancer Network
practice guidelines.
"These updated Phase 2 data are consistent with earlier studies of
picoplatin in this difficult-to-treat patient population and compare
favorably with the median survival for the entire population of relapsed
patients who receive other second-line chemotherapy," said Jerry McMahon,
Ph.D., chairman and CEO of Poniard. "These results are promising because
patients with platinum-resistant and -refractory small cell lung cancer
have very limited treatment options. They typically experience rapid
disease progression and low overall survival following treatment with
existing chemotherapies, which have significant toxicities."
The updated picoplatin Phase 2 data were presented during a poster
discussion session at the International Association for the Study of Lung
Cancer's (IASLC) 12th World Conference on Lung Cancer in Seoul, Korea.
Additional Phase 2 Study Findings
In addition to the overall and one-year survival findings, the updated
analysis of results from the open-label, multi-center Phase 2 trial showed
that the disease control rate was 48.1 percent in the 77 evaluable
patients. This is similar to that observed with currently available
treatments, but with a more manageable side effect profile and less
frequent administration. At the time of the updated analysis, 63 patients
had died from disease progression. The most common side effects were
hematologic and included thrombocytopenia, anemia and neutropenia. No grade
3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths
occurred.
Pivotal Phase 3 SPEAR Trial Design
Poniard's ongoing international, multi-center, randomized, controlled
SPEAR trial is comparing picoplatin plus best supportive care to best
supportive care alone to evaluate the efficacy of picoplatin after relapse.
Best supportive care includes care and treatment to optimize the comfort of
patients and their ability to function, as well as to minimize the side
effects of palliative cancer treatments. The primary efficacy endpoint is
overall survival, with overall response rates, progression-free survival
and disease control also being evaluated. The trial, which is enrolling
patients who are refractory to, or who have progressed within six months of
completing, treatment with first-line platinum chemotherapy (cisplatin or
carboplatin), is being conducted at clinical sites in Europe and India.
"Since the initiation of the SPEAR trial in the second quarter of 2007,
we have made significant progress in opening approximately 100 clinical
sites and in treating patients," said David A. Karlin, M.D., senior vice
president, clinical development and regulatory affairs for Poniard. "We
anticipate reaching our enrollment target in the first half of 2008,
potentially supporting a New Drug Application filing in 2009."
About Picoplatin
Picoplatin is a new generation platinum chemotherapy agent. It was
designed to overcome platinum resistance and to prolong the time to relapse
after chemotherapy in the treatment of solid tumors, and to have an
improved safety profile compared with existing platinum-based
chemotherapeutics. Poniard received orphan drug designation from the FDA in
November 2005 for picoplatin for the treatment of SCLC.
In addition to the ongoing SPEAR trial, Poniard is also evaluating
intravenous picoplatin in an ongoing Phase 1 clinical trial as a first-line
treatment for metastatic colorectal cancer and in an ongoing Phase 2 trial
in combination with docetaxel (Taxotere(R)) and prednisone in patients with
metastatic hormone-refractory prostate cancer.
About Small Cell Lung Cancer
SCLC is the most aggressive and deadly form of lung cancer and accounts
for approximately 20 percent of all lung cancer cases. The current two-year
survival rate for patients with extensive SCLC is less than 10 percent with
current management options. The estimated incidence of lung cancer in the
United States in 2006 was 174,500, according to the National Cancer
Institute. The estimated incidence in Europe in 2006 was 386,300, according
to the International Agency for Research on Cancer.
SCLC is currently treated with platinum therapies, but many patients do
not respond, and if they do respond, they typically relapse within a short
time after treatment. There is currently no FDA-approved therapy and no
consistent and effective therapy for SCLC patients who have
platinum-resistant or -refractory disease after treatment failure with
first-line combination therapy with either cisplatin or carboplatin. No new
drugs have been approved by the FDA for the treatment of platinum-resistant
or -refractory SCLC in nearly a decade.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical 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. Picoplatin is designed to overcome and prevent
platinum resistance associated with chemotherapy in solid tumors.
Intravenous picoplatin is currently being studied in clinical trials for
the treatment of small cell lung, colorectal and hormone-refractory
prostate cancer, and oral picoplatin is in a clinical trial in solid
tumors. As part of the Company's strategic goal of building a diverse
oncology pipeline, the Company is collaborating with The Scripps Research
Institute on the discovery of novel, small-molecule, multi-targeted protein
kinase inhibitors. For additional information please visit
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This release contains forward-looking statements, including statements
regarding the Company's business objectives and strategic goals, drug
development plans, results of clinical trials and the potential safety and
efficacy of its products in development. The Company's actual results may
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based on a number of factors, including risks and uncertainties associated
with the Company's research and development activities; the results of pre-
clinical and clinical testing; the receipt and timing of required
regulatory approvals; the market's acceptance of the Company's proposed
products; 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 intellectual
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Company's ability to attract and retain key personnel; changes in
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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, 2006,
as amended, and the Company's Quarterly Report on Form 10-Q for the period
ended June 30, 2007. 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) 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard
Pharmaceuticals, Inc.
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