Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused
on oncology, today announced that it has completed patient enrollment in
its Phase 2 clinical trial evaluating picoplatin combination chemotherapy
for the first-line treatment of metastatic colorectal cancer (CRC). Early
data from this trial are expected in the second half of 2008. 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.
"Picoplatin, to date, has demonstrated good tolerability, with no
severe neuropathies when combined with 5-fluorouracil and leucovorin in the
FOLPI regimen. In our Phase 2 trial, we are performing a head-to-head
comparison of the efficacy and safety of picoplatin with oxaliplatin. We
will be presenting preliminary Phase 2 data and updated Phase 1 data at the
2008 American Society of Clinical Oncology (ASCO) Annual Meeting, and we
anticipate more clinical data this year for presentations at various
scientific meetings," said Robert De Jager, M.D., chief medical officer of
Poniard. "The data from our ongoing Phase 2 trial could establish
picoplatin as a platform product and provide a solid foundation for
supporting additional registration trials, thereby expanding the potential
of this product."
Picoplatin is a chemotherapeutic agent that has an improved safety
profile compared to existing platinum-based chemotherapeutics. It was
designed to overcome platinum resistance associated with the treatment of
solid tumors. 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.
Phase 2 Study Details
The Phase 2 study is a two-arm, randomized, controlled 100-patient
trial of first-line treatment of metastatic CRC. The objective of the Phase
2 trial is to compare the safety and efficacy of intravenous picoplatin
given once every four weeks in the FOLPI regimen with oxaliplatin in
combination with 5- fluorouracil and leucovorin in the modified FOLFOX-6
regimen and to evaluate clinical activity. Poniard expects to generate
proof-of-concept data from the Phase 2 trial demonstrating that picoplatin
has an improved safety profile. This trial could position picoplatin as the
preferred platinum agent for the first-line treatment of metastatic
colorectal cancer and could potentially enable a Phase 3 study.
-- Poniard initiated the Phase 2 trial in November 2007 based on clinical
activity and promising safety data observed in its 50-patient, Phase 1
dose-escalation study of picoplatin in the FOLPI regimen as a
first-line treatment for metastatic CRC. Results of the Phase 1 trial
were presented at the ASCO Gastrointestinal Cancers Satellite Symposium
in January and demonstrated that picoplatin has a manageable toxicity
in combination with 5-fluorouracil and leucovorin Picoplatin did not
cause severe neurotoxicity (Grade 3 or higher), as is commonly seen in
metastatic CRC patients treated with oxaliplatin as part of the FOLFOX
regimen. Current National Comprehensive Cancer Network (NCCN) Clinical
Practice Guidelines in Oncology for colon cancer encourage the
discontinuation of FOLFOX after three months of therapy or sooner if
significant neurotoxicity develops (Grade 3 or greater).
Nephrotoxicities and ototoxicities were rare and mild.
Poniard anticipates presenting efficacy and safety data at scientific
meetings, including preliminary data from the Phase 2 and updated data from
the Phase 1 CRC trials at ASCO in June.
About Picoplatin
Picoplatin, the Company's lead platform product candidate, is a new
generation platinum therapy with an improved safety profile relative to
existing platinum-based cancer therapies. Picoplatin is designed to
overcome platinum resistance associated with chemotherapy in solid tumors,
and is being studied in multiple cancer indications, combinations and
formulations. In addition to the ongoing Phase 2 clinical trial in patients
with metastatic CRC, Poniard is evaluating intravenous picoplatin in an
ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy
After Relapse), in SCLC. 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. The Company is also evaluating intravenous picoplatin in an
ongoing Phase 2 clinical trial for the treatment of hormone-refractory
prostate 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, which will be filed with the SEC on or about May 8, 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.
Poniard Pharmaceuticals, Inc.
http://www.poniard.com
