SOUTH SAN FRANCISCO, Jan. 8 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today provided an overview of its 2009 clinical goals for development of 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. It is currently being evaluated in a Phase 3 registrational trial (SPEAR or Study of Picoplatin Efficacy After Relapse) in small cell lung cancer (SCLC), and in Phase 2 clinical trials as a first-line chemotherapy in colorectal cancer (CRC) and hormone-refractory (HRPC) or castration-resistant (CRPC) prostate cancer. Picoplatin is designed to overcome platinum resistance and has the potential for an improved safety profile compared to other platinum-based chemotherapies currently in use.
"We expect that 2009 will be a catalytic year for Poniard, as we expect to complete enrollment in our ongoing registration trial in small cell lung cancer. We believe the results of this trial could support an NDA filing, leading to approval and commercialization of picoplatin in 2010," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We continue to execute our clinical strategy to broaden picoplatin's potential as a platform product. We plan to present clinical data from our other ongoing Phase 2 colorectal and prostate cancer trials at multiple medical conferences. These data, together with picoplatin data in over 750 patients in a broad range of tumor types supports future development and use of picoplatin for the treatment of lung, colorectal, ovarian, prostate, breast, head and neck, bladder, pancreatic and other cancers."
"Poniard is fortunate to have sufficient funding to operate the company into 2010; a management team with a demonstrated ability to bring oncology programs to market; and a Phase 3 oncology product currently on track for initial commercialization in 2010," said Ronald A. Martell, president and COO of Poniard. "We plan to continue to focus our efforts on completing all of the necessary elements that will allow us to prepare and file our NDA. We will also continue to evaluate partnership opportunities that would enable us to maximize picoplatin as a franchise product worldwide."
Poniard plans to work toward the achievement of the following picoplatin goals in 2009:
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.
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. It has an improved safety profile relative to existing platinum-based cancer therapies. 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. 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 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, timing and results of clinical trials, the potential safety and efficacy of its products in development and commercialization strategy. 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 FDA and other 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 its Quarterly Report on Form 10-Q for the period ended September 30, 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) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
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