Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a specialty pharmaceutical company
focused on oncology, today announced positive interim median overall
survival data from its ongoing Phase 2 clinical trial of picoplatin in
patients with small cell lung cancer (SCLC). The trial includes SCLC
patients with platinum-refractory disease or platinum-resistant or
platinum-sensitive disease who have progressed within six months after
receiving first-line therapy. Based on these data, Poniard plans to
initiate a pivotal Phase 3 trial of picoplatin in SCLC in the first half of
2007 and file a New Drug Application for this indication in 2009. The
Company anticipates that the primary endpoint of the planned Phase 3 trial
will be survival and expects to enroll approximately 400 patients in the
trial.
Picoplatin is a new generation platinum therapy with an improved safety
profile designed to overcome and prevent platinum resistance associated
with chemotherapy in solid tumors.
"SCLC presents a critical unmet medical need with inadequate treatment
options," said John R. Eckardt, M.D., a Phase 2 clinical trial investigator
and medical oncologist at The Center for Cancer Care and Research in St.
Louis. "Platinum-resistant or -refractory SCLC patients often experience
rapid disease progression and low overall survival despite treatment with
available drugs, which have significant associated toxicities."
No new drugs have been approved by the U.S. Food and Drug
Administration (FDA) for the treatment of platinum-resistant or -refractory
SCLC in nearly a decade.
"It appears that in addition to potentially extending survival in these
patients, picoplatin may offer better quality of life because of its
improved safety profile over current treatment options," said Jerry
McMahon, Ph.D., chairman, president and CEO of Poniard. "We believe that
the planned Phase 3 SCLC trial will be an important step forward on the
path to market for picoplatin. We also believe our current financial
resources will enable us to initiate the Phase 3 study, complete our
ongoing Phase 2 trial in SCLC, and initiate and complete patient enrollment
in our planned Phase 2 studies in colorectal and prostate cancers next
year."
Summary of Interim Phase 2 Survival Results
Enrollment in the open-label, multi-center Phase 2 trial was completed
in August 2006. This ongoing trial is designed to confirm the clinical
activity of picoplatin as second-line therapy in 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.
A recent 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. There were
not sufficient data on the last five patients enrolled in the Phase 2 study
to include them in the interim analysis. However, data for all patients
will be included in the final analysis.
In addition to overall survival, the Phase 2 trial is evaluating
overall response rates, progression-free survival, improvement in
disease-related symptoms and disease control. Final results of this trial
are expected in mid-2007 and will be submitted for presentation at upcoming
scientific conferences.
"The median overall survival observed to date in our Phase 2 trial
confirms our previous data and suggests that picoplatin treatment may
represent an improvement over best supportive care alone," said David A.
Karlin, M.D., senior vice president of clinical development and regulatory
affairs of Poniard. "We have designed our Phase 3 trial with these
observations in mind and are regularly communicating and working closely
with the FDA in our efforts to bring this drug to market for these severely
underserved patients."
Poniard's planned international, multi-center, randomized Phase 3
pivotal trial is expected to take about 20 months to complete, with a 2:1
randomization comparing picoplatin plus best supportive care to best
supportive care alone. The planned trial would enroll patients who are
refractory to, or who have progressed within six months of completing,
treatment with first-line platinum chemotherapy (cisplatin or carboplatin).
Beyond the primary endpoint of overall survival, the study would also
measure overall response rates, progression-free survival and disease
control.
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 is 174,500, according to the National Cancer
Institute. The estimated incidence in Europe in 2004 was 383,900, according
to the International Agency for Research on Cancer. Poniard received orphan
drug designation in November 2005 from the FDA for picoplatin for the
treatment of SCLC.
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.
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 June 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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