- Poster Presented at ASCO Annual Meeting - SOUTH SAN FRANCISCO, Calif. and CHICAGO, May 31
SOUTH SAN FRANCISCO, Calif. and CHICAGO, May 31 /PRNewswire-FirstCall/ --
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company
focused on oncology, today presented preliminary safety and efficacy data from
its ongoing Phase 2 clinical trial of picoplatin in combination with docetaxel
and prednisone, the standard of care for the first-line treatment of
metastatic hormone-refractory prostate cancer (HRPC). Results demonstrated
that picoplatin can be safely administered with full doses of docetaxel. In
addition, the prostate specific antigen (PSA) response rate was 69 percent in
26 patients evaluable for PSA.
The Company presented the Phase 2 data (abstract #5153) in the General
Poster Session during the 44th Annual Meeting of the American Society of
Clinical Oncology (ASCO) at McCormick Place in Chicago. Picoplatin, the
Company's lead product candidate, is a new generation platinum chemotherapy
agent with the potential to become a platform product addressing multiple
indications, combinations and formulations.
"The promising results of this Phase 2 trial in HRPC support further
development of picoplatin in the treatment of prostate cancer," said Robert De
Jager, M.D., chief medical officer of Poniard. "A prospective randomized trial
is under consideration. The combination of picoplatin with a taxane could be
further evaluated in other tumor types, such as ovarian cancer and non-small
cell lung cancer."
Phase 2 HRPC Study Preliminary Results
In the ongoing Phase 2 trial, the efficacy and safety of intravenous
picoplatin (120 mg/m squared) administered every 21 days in combination with
full-dose docetaxel (75 mg/m squared) with daily prednisone (5 mg) as a
first-line treatment is being evaluated in 30 patients with metastatic HRPC.
PSA response (defined as a PSA reduction of at least 50 percent from baseline)
is the primary endpoint; secondary endpoints include safety, response rate,
time to progression and overall survival. The trial completed enrollment in
December 2007.
Results to date have shown a PSA response in 18 of 26 (69 percent)
evaluable patients. Furthermore, PSA levels have normalized in six patients
(21 percent). The combination of picoplatin and docetaxel can be safely
administered with manageable and reversible neutropenia as the main
hematologic toxicity. These data confirm earlier results observed in the Phase
1 trial. In contrast to picoplatin monotherapy, thrombocytopenia was less
severe and less frequent. Neurotoxicity has not been observed in this study.
About Picoplatin
Picoplatin has an improved safety profile relative to existing
platinum-based cancer therapies and is designed to overcome platinum
resistance associated with chemotherapy in solid tumors. It is being studied
in multiple cancer indications, combinations and formulations. Picoplatin has
been evaluated in more than 750 patients and has demonstrated anti-tumor
activity in multiple indications with less severe kidney toxicity
(nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed
with other platinum chemotherapy drugs.
In addition to the ongoing Phase 2 clinical trial in HRPC, Poniard is
evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known
as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung
cancer. This registration trial currently is being conducted under a Special
Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is
evaluating overall survival as the primary endpoint. Picoplatin is also being
evaluated in an ongoing Phase 2 clinical trial in patients with metastatic
colorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinical
trial in solid tumors. The oral formulation of picoplatin has the same active
pharmaceutical ingredient as the intravenous formulation. Picoplatin has not
been approved by any regulatory authority for use in humans.
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 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
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
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 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, 2007 and Quarterly Report on Form 10-Q for the quarter ended
March 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.
(C) 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard
Pharmaceuticals, Inc.
SOURCE Poniard Pharmaceuticals, Inc.
