Poniard Announces Publication of Results of Picoplatin Phase 2 Study in Journal of...

Poniard Announces Publication of Results of Picoplatin Phase 2 Study in
Journal of Clinical Oncology

- Findings Demonstrate Survival Benefit with Picoplatin as Second-Line Therapy
for Small Cell Lung Cancer -

SOUTH SAN FRANCISCO, Calif., April 20 /PRNewswire-FirstCall/ -- Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on
oncology, today announced that results of its Phase 2 clinical trial of
picoplatin in patients with recurrent small cell lung cancer (SCLC) were
published in the April 20, 2009, print issue of the Journal of Clinical
Oncology(1). Picoplatin demonstrated a survival benefit in this open-label,
multi-center Phase 2 trial of SCLC patients who failed prior
platinum-containing first-line chemotherapy or who progressed within six
months of first-line therapy. The median overall survival was 27 weeks and the
median one-year survival rate was 17.6 percent in this patient population of
mostly platinum-refractory and -resistant patients.

Poniard is currently evaluating the efficacy and safety of picoplatin in the
pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) SCLC trial,
which is being conducted under a Special Protocol Assessment (SPA) agreement
with the U.S. Food and Drug Administration (FDA). The Company reached its
enrollment target in this international, multi-center, randomized, controlled
trial in March 2009.

SCLC is the most aggressive lung cancer and tends to be widely disseminated by
the time of diagnosis. The prognosis for patients with SCLC that has
progressed despite chemotherapy is exceedingly poor regardless of stage.
Effective second-line treatment for SCLC is a major unmet need. There is no
standard chemotherapy for second-line platinum-refractory or -resistant SCLC.

"New treatments are desperately needed for patients with platinum-resistant
and -refractory small cell lung cancer due to the rapid relapse of the disease
and the slim chance that patients will experience long-term survival," said
John Eckardt, M.D., lead author of the JCO publication, picoplatin clinical
trial investigator, and chief medical officer of DAVA Oncology. "I am
encouraged that picoplatin extended survival in this patient group and was
generally well tolerated. Data from the Phase 3 SPEAR trial in the same
patient population will further clarify the potential of picoplatin as a
viable treatment for patients with this highly lethal type of cancer."

Phase 2 Study Design and Results
The open-label, multi-center Phase 2 trial was designed to confirm the
clinical activity and safety of picoplatin as second-line therapy in patients
with platinum-refractory disease or platinum-resistant or platinum-sensitive
disease that had progressed within six months after first-line treatment with
a platinum-based chemotherapy, such as cisplatin or carboplatin. Efficacy
endpoints included response rates, progression-free survival, overall
survival, improvement in disease-related symptoms and disease control (defined
as complete response, partial response and stable disease). The trial was
conducted at clinical sites in North America and Eastern Europe.

A total of 77 patients received picoplatin. Median overall survival was 27
weeks following picoplatin administered once every three weeks. Median
progression-free survival was 9 weeks. The six-month and one-year survival
rates were 51 percent and 17 percent, respectively. The disease control rate
was 47 percent in the 77 evaluable patients. The most common side effects
observed were hematologic and included thrombocytopenia, neutropenia and
anemia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no
treatment-related deaths occurred in the study.

"The publication of these clinical findings in JCO represents an important
milestone for Poniard. The positive survival results of the Phase 2
picoplatin trial in this difficult-to-treat disease formed the basis of our
decision to initiate the Phase 3 SPEAR trial for which we recently completed
patient enrollment ahead of internal projections," said Robert De Jager, M.D.,
chief medical officer of Poniard. "We are on track to complete the clinical
data analysis of the SPEAR trial and initiate the filing of a rolling New Drug
Application with the FDA for picoplatin in SCLC this year. If approved,
picoplatin could represent an important new treatment for SCLC. In addition,
it potentially enables other trials of picoplatin in patients with other solid
tumors who relapse or are refractory to first-line platinums, such as in
non-small cell lung cancer and ovarian cancer."

About Picoplatin
Picoplatin is designed to overcome platinum resistance associated with
chemotherapy in solid tumors. Study data to date indicate that it has an
improved safety profile relative to existing platinum-based cancer therapies.
More than 1,100 patients have been treated with picoplatin. Results obtained
to date suggest manageable hematologic adverse events with less severe kidney
toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly
observed with other platinum chemotherapy drugs. Picoplatin has demonstrated
anti-tumor activity in a variety of solid tumors. It is being studied in
multiple cancer indications, treatment combinations and by two routes of
administration.

The SPEAR trial is comparing picoplatin plus best supportive care, to best
supportive care alone, to evaluate the efficacy and safety of picoplatin after
relapse in SCLC patients. The primary efficacy endpoint is overall survival.
Progression-free survival, overall response rate, and disease control are also
being evaluated. The Company is currently evaluating picoplatin in two Phase 2
clinical trials -- one is evaluating the safety and efficacy of picoplatin in
patients with metastatic colorectal cancer and the other in patients with
castration-resistant (or hormone-refractory) prostate cancer. Oral picoplatin
is being evaluated in a Phase 1 clinical trial in solid tumors.

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.

This release contains forward-looking statements, including statements
regarding the Company's results of clinical trials, business objectives and
strategic goals, drug development plans, the potential safety and efficacy of
its products in development and commercialization strategy. 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 associated with the Company's research and development
activities; the results of clinical testing; the receipt and timing of FDA and
other 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 property rights;
the Company's dependence on third-party manufacturers and suppliers; the
Company's lack of sales and marketing experience; the Company's ability to
attract and retain key personnel; 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. 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.

(1) Eckardt JR, Bentsion DL, Lipatov ON, et al. Phase II Study of Picoplatin
as Second-Line Therapy for Patients With Small-Cell Lung Cancer. JCO
2009;27:2046-2051.

(C) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals,
Inc.

SOURCE Poniard Pharmaceuticals, Inc.

Rebecca Der of Burns McClellan, +1-212-213-0006, rder@burnsmc.com; or Jani
Bergan of WeissComm Partners, +1-415-946-1064, jbergan@wcpglobal.com, for
Poniard Pharmaceuticals, Inc.