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"We expect that 2009 will be a catalytic year for Poniard, as we expect tocomplete enrollment in our ongoing registration trial in small cell lungcancer. We believe the results of this trial could support an NDA filing,leading to approval and commercialization of picoplatin in 2010," said JerryMcMahon, Ph.D., chairman and CEO of Poniard. "We continue to execute ourclinical strategy to broaden picoplatin's potential as a platform product. Weplan to present clinical data from our other ongoing Phase 2 colorectal andprostate cancer trials at multiple medical conferences. These data, togetherwith picoplatin data in over 750 patients in a broad range of tumor typessupports future development and use of picoplatin for the treatment of lung,colorectal, ovarian, prostate, breast, head and neck, bladder, pancreatic andother cancers."
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"Poniard is fortunate to have sufficient funding to operate the companyinto 2010; a management team with a demonstrated ability to bring oncologyprograms to market; and a Phase 3 oncology product currently on track forinitial commercialization in 2010," said Ronald A. Martell, president and COOof Poniard. "We plan to continue to focus our efforts on completing all of thenecessary elements that will allow us to prepare and file our NDA. We willalso continue to evaluate partnership opportunities that would enable us tomaximize picoplatin as a franchise product worldwide."
Poniard plans to work toward the achievement of the following picoplatingoals in 2009:
About Picoplatin
Picoplatin is designed to overcome platinum resistance associated withchemotherapy in solid tumors. It has an improved safety profile relative toexisting platinum-based cancer therapies. Picoplatin has been evaluated inmore than 750 patients and has demonstrated anti-tumor activity in multipleindications with less severe kidney toxicity (nephrotoxicity) and nervetoxicity (neurotoxicity) than is commonly observed with other platinumchemotherapy drugs. It is being studied in multiple cancer indications,treatment combinations and in two formulations.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused onthe development and commercialization of innovative oncology products toimpact the lives of people with cancer. For additional information pleasevisit http://www.poniard.com.
This release contains forward-looking statements, including statementsregarding the Company's business objectives and strategic goals, drugdevelopment plans, timing and results of clinical trials, the potential safetyand efficacy of its products in development and commercialization strategy.The Company's actual results may differ materially from those indicated inthese forward-looking statements based on a number of factors, including risksand uncertainties associated with the Company's research and developmentactivities; the results of pre-clinical and clinical testing; the receipt andtiming of FDA and other required regulatory approvals; the market's acceptanceof the Company's proposed products; the Company's anticipated operatinglosses, need for future capital and ability to obtain future funding;competition from third parties; the Company's ability to preserve and protectintellectual property rights; the Company's dependence on third-partymanufacturers and suppliers; the Company's lack of sales and marketingexperience; the Company's ability to attract and retain key personnel; changesin technology, government regulation and general market conditions; and therisks and uncertainties described in the Company's current and periodicreports filed with the Securities and Exchange Commission (SEC), including theCompany's Annual Report on Form 10-K for the year ended December 31, 2007 andits Quarterly Report on Form 10-Q for the period ended September 30, 2008.Readers are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date of this release. The Companyundertakes no obligation to update any forward-looking statement to reflectnew information, events or circumstances after the date of this release or toreflect the occurrence of unanticipated events.
(C) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of PoniardPharmaceuticals, Inc.Small Cell Lung Cancer -- Complete enrollment in the ongoing Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial. This pivotal registration trial is evaluating intravenous picoplatin in SCLC patients who have failed or relapsed following initial platinum therapy within six months of initial treatment. The trial, which is being conducted under a Special Protocol Assessment (SPA) from the FDA, is evaluating overall survival as the primary endpoint. The FDA also has granted Fast-Track status, which may enable an expedited review. -- Initiate NDA filing with the U.S. Food and Drug Administration (FDA). Colorectal Cancer -- Present clinical data from the Phase 2 trial of picoplatin in patients with metastatic CRC at the American Society of Clinical Oncology's (ASCO) 2009 Gastrointestinal Cancers Symposium on January 17 in San Francisco. This randomized, controlled trial is evaluating picoplatin as a neuropathy-sparing replacement for oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who have not received prior chemotherapy. The trial is comparing the safety, including neuropathy, and efficacy of intravenous picoplatin in combination with 5-fluorouracil and leucovorin (the FOLPI regimen) to oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen. -- Present updated Phase 2 clinical data, including progression-free and overall survival data from this trial, at additional medical conferences. -- Present final Phase 1 FOLPI clinical data comparing once monthly and bi-weekly picoplatin administration at key medical conferences. Hormone-Refractory or Castration-Resistant Prostate Cancer -- Present data from the ongoing Phase 2 trial of picoplatin in patients with metastatic HRPC at ASCO's 2009 Genitourinary Cancers Symposium on February 27 in Orlando, Fla. This study is evaluating the efficacy and safety of picoplatin administered every three weeks in combination with full-dose docetaxel and daily prednisone as a first- line treatment in patients with metastatic HRPC or CRPC who have not received prior chemotherapy. PSA response (defined as a PSA reduction of at least 50 percent from baseline) is the primary endpoint, and secondary endpoints include safety, tumor response rate, time to progression and overall survival. -- Present updated Phase 2 clinical data, including time to disease progression and overall survival data, at additional medical conferences. Oral Picoplatin Program -- Present final data from the Phase 1 trial of orally vs. intravenously administered picoplatin in patients with advanced solid tumor malignancies at medical conferences.
SOURCE Poniard Pharmaceuticals, Inc.
