- Phase 2 Data To Be Presented Along With Updated Phase 1 Colorectal Cancer
Data at ASCO Annual Meeting -
SOUTH SAN FRANCISCO, Calif. and CHICAGO, June 1 /PRNewswire-FirstCall/
-- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical
company focused on oncology, today announced positive preliminary results
from its ongoing randomized Phase 2 clinical trial in patients with
metastatic colorectal cancer (CRC) and updated results from an ongoing
Phase 1 CRC trial. Preliminary data suggest that picoplatin given in
combination with 5-fluorouracil and leucovorin (FOLPI) and oxaliplatin
given in combination with 5-fluorouracil and leucovorin (FOLFOX) may have
similar anti-tumor activity in metastatic CRC.
The Company will present the Phase 1 and 2 picoplatin data (abstract
#4100) 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 for the
treatment of multiple solid tumor indications.
"The comparison of picoplatin and oxaliplatin in combination with
5-fluorouracil and leucovorin has provided encouraging preliminary
results," said Robert De Jager, M.D., chief medical officer of Poniard.
"These data support our strategy of developing picoplatin as a preferred
platinum for the first-line treatment of metastatic CRC. The ongoing Phase
2 trial could support advancement of picoplatin into a registration trial."
Phase 2 CRC Study Preliminary Results
The randomized, controlled, 100-patient Phase 2 study is comparing the
safety and efficacy of intravenous picoplatin given once every four weeks
in combination with 5-fluorouracil and leucovorin in the FOLPI regimen with
oxaliplatin in combination with 5-fluorouracil and leucovorin in the
modified FOLFOX-6 regimen.
Preliminary data suggest that FOLPI and FOLFOX may have similar
anti-tumor activity in metastatic CRC. Preliminary data representing 61
patients will be presented. Of 11 evaluable patients in the FOLPI arm, 10
achieved disease control (partial response combined with stable disease),
including two partial responses. Of 13 evaluable patients in the FOLFOX
arm, 10 achieved disease control, including one partial response. A total
of 37 patients across both arms are too early for evaluation.
Expanded and Updated Phase 1 CRC Study Results
In the Phase 1 dose-escalation study, 70 patients were treated with
FOLPI with picoplatin treatment administered either every two or four
weeks. Patients have received a total picoplatin exposure of between 85
mg/m2 and 1,350 mg/m2, representing up to 28 cycles of picoplatin therapy.
The dose limiting toxicity (DLT) for the every-four-week regimen at 180
mg/m2 was hematologic with neutropenia and thrombocytopenia as the most
frequent adverse events. The maximum tolerated dose (MTD) in the
every-four-week FOLPI schedule was previously reported to be hematologic
and occurred at 150 mg/m2. The MTD in the every-two-week FOLPI schedule of
picoplatin when infused with 5-fluorouracil and leucovorin has not yet been
reached, and the trial is ongoing at a dose of 135 mg/m2.
None of the Phase 1 patients treated with picoplatin exhibited severe
neuropathy (Grade 3 or 4), as is commonly seen in metastatic CRC patients
treated with oxaliplatin in combination with 5-fluorouracil and leucovorin
as part of the FOLFOX regimen. Neurotoxicities were not related to
cumulative exposure of picoplatin. Nephrotoxicities and ototoxicities were
rare and mild with the FOLPI 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
(Grade 3 or greater) develops.
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 CRC, 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 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. 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.
See Also
- Ephedramaxx: The Most Effective Fat Burning Diet Pill
- Shape Up Your Body With The Best Ephedra Supplement
- Penn State Hershey Transplant Program Uses Assay to Monitor Cell-Mediated Immunity
- Magic of Sexy Lips
Via: Healthcare
0 коментарі:
Post a Comment