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Poniard Pharmaceuticals Provides 2008 Clinical Goals for Picoplatin

Posted on: Monday, 7 January 2008, 09:00 CST

SOUTH SAN FRANCISCO, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today provided an overview of its clinical goals for 2008 for picoplatin, its lead product candidate. Picoplatin is a new generation platinum-based chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.

"In 2008, we anticipate several important clinical development advancements in all four of our picoplatin programs that will further enhance picoplatin's product potential," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We expect results of our ongoing SPA-approved Phase 3 trial of picoplatin in small cell lung cancer to support application with the FDA for marketing approval in 2009."

Poniard expects to achieve the following in 2008: Phase 3 SPEAR Trial in Small Cell Lung Cancer The Company continues to estimate that it will complete enrollment of the SPEAR (Study of Picoplatin Efficacy After Relapse) trial in the third quarter of 2008 and announce top-line data by year-end. The Company anticipates filing a New Drug Application (NDA) with the FDA in 2009. The SPEAR trial is evaluating intravenous picoplatin in platinum-refractory and -resistant small cell lung cancer (SCLC) patients who have failed or relapsed from initial therapy within six months of initial treatment. Overall survival is the primary endpoint of this registrational trial, which is being conducted under a Special Protocol Assessment process (SPA) as agreed with the U.S. Food and Drug Administration (FDA). Fast-track designation has also been granted by the FDA, enabling a rolling NDA submission to expedite review. Colorectal Cancer Program Data from the Phase 1 trial of picoplatin in patients with colorectal cancer (CRC) has been accepted for presentation at the American Society of Clinical Oncology's (ASCO) 2008 Gastrointestinal Cancers Symposium, which is taking place January 25-27 in Orlando, Fla. The Company expects to fully enroll its Phase 2 CRC trial in the first half of 2008. The Company also expects to have final data from the Phase 1 CRC trial in 2008 and to present clinical data from both the Phase 1 and Phase 2 CRC trials at scientific meetings throughout the year. The ongoing, two-arm, randomized 100-patient Phase 2 trial is evaluating picoplatin as a neuropathy-sparing replacement for oxaliplatin for the first-line treatment of metastatic CRC. The Company is evaluating picoplatin in combination with 5-fluorouracil and leucovorin, or FOLPI, compared to the FOLFOX regimen (oxaliplatin in combination with 5-fluorouracil and leucovorin). Hormone-Refractory Prostate Cancer Program Data from the Phase 1 trial of picoplatin in patients with hormone-refractory prostate cancer (HRPC) has been accepted for presentation at ASCO's 2008 Genitourinary Cancers Symposium, which is taking place February 14-16 in San Francisco. Poniard expects to have final data from the Phase 1 HRPC trial in 2008 and to present clinical data from both the Phase 1 and Phase 2 HRPC trials at scientific meetings throughout the year. The Phase 2 trial was designed to evaluate the combination of picoplatin with the FDA recommended dosage of docetaxel and prednisone, the standard of care, for first-line treatment of metastatic HRPC. Enrollment for the Phase 2 study was completed in December 2007. Phase 1 Oral Picoplatin Trial The Company plans to present data at scientific meetings in 2008 from its ongoing Phase 1 trial to evaluate an oral formulation of picoplatin for the treatment of solid tumors. The Company has completed the enrollment at the original planned dose levels. This study is expanded, based on promising findings, to include additional dose levels to enhance data analysis. The Phase 1 study is comparing the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin administered intravenously in patients with advanced solid tumor malignancies. 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. Picoplatin, the Company's lead platform product candidate, is a new generation platinum therapy with an improved safety profile compared to currently available platinum-based therapies. Picoplatin is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and hormone-refractory prostate 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, including the Company's Annual Report on Form 10-K for the year ended December 31, 2006, as amended, and most current Quarterly Report on Form 10-Q. 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.

CONTACT: Brendan Doherty of Poniard Pharmaceuticals, Inc., CorporateCommunications, +1-650-745-4425, bdoherty@poniard.com

Web site: http://www.poniard.com/

Source: PRNewswire-FirstCall

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