SOUTH SAN FRANCISCO, June 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced the full efficacy and safety data from its Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC). Dr. Tudor Eliade Ciuleanu, M.D., Ph.D., of Institute of Oncology, Cluj-Napoca, Romania and an investigator for the SPEAR trial, presented the data during an oral session at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting in Chicago, IL.
"Results from this important study show that picoplatin is an active compound, with a demonstrated survival benefit among patients where the use of post-study chemotherapy between treatment arms was balanced," stated Dr. Ciuleanu. "These data include a number of significant outcomes, including improved overall survival among those individuals who did not receive post-study chemotherapy, the study's principal confounding factor, and among early relapsing or platinum refractory patients, a clinically meaningful population. Further, picoplatin exhibits a manageable safety profile consistent with prior clinical experience. These results warrant further investigation in this indication."
"The SPEAR trial provides valuable insight into picoplatin's potential as an effective new treatment option for the vastly underserved early relapsing or platinum refractory SCLC patient population," said Ronald A. Martell, chief executive officer of Poniard Pharmaceuticals. "These results are encouraging, both for Poniard and the oncologists addressing this difficult to treat disease. We continue to work toward establishing a path forward for picoplatin in this indication, as well as in other solid tumors where picoplatin has produced meaningful safety and efficacy data."
SPEAR Trial Design
The international, multi-center, randomized, controlled Phase 3 SPEAR trial, one of the largest SCLC studies ever conducted, evaluated the efficacy and safety of picoplatin in 401 patients with SCLC who were refractory to or who progressed within six months of first-line platinum-based therapy. Picoplatin administered as an intravenous infusion once every three weeks plus best supportive care (BSC) was compared to BSC alone. BSC was designed in accordance with the National Comprehensive Cancer Network's guidelines. The primary endpoint of the trial was overall survival. Other endpoints included disease control rate, time to progression and progression-free survival (PFS). The trial was powered at 90 percent to show a 33 percent reduction in risk of death for picoplatin treatment plus BSC compared with BSC alone (hazard ratio of 0.67; p value of 0.05).
SPEAR Trial Data
The data presented demonstrated:
Best of ASCO 2010
In addition to the oral presentation, the SPEAR data presentation was designated as one of the "Best of ASCO 2010" and will be featured in San Francisco and Boston in July, and other local settings around the world following the ASCO Annual Meeting. This is an ASCO-sponsored program that features abstracts from the 2010 ASCO Annual Meeting and provides greater accessibility to important scientific research presented by respected members of the oncology community.
Picoplatin is a new and differentiated platinum-based chemotherapeutic agent that is in clinical development for multiple cancer indications, treatment combinations and by two routes of administration. It is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and can be safely administered in combination with multiple approved oncology products. Approximately 1,100 patients have received picoplatin. Results obtained to date suggest that hematologic events are common but manageable. Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less frequent and less severe than is commonly observed with other platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors.
About Small Cell Lung Cancer
SCLC is the most aggressive form of lung cancer and tends to be widespread by the time of diagnosis. According to the American Cancer Society, SCLC accounts for about 10 to 15 percent of all lung cancers. An estimated 32,000 new cases of SCLC were expected to be diagnosed in the United States in 2009, and 52,000 SCLC patients were projected to be treated in the United States in 2008.1 The prognosis for patients with SCLC that have progressed despite chemotherapy is exceedingly poor. Effective second-line treatment for SCLC is a major unmet need. There is no standard chemotherapy for SCLC patients that do not respond to initial platinum-based treatment.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products. For additional information please visit http://www.poniard.com.
Forward Looking Statements
This release contains forward-looking statements, including, without limitation, results of the Company's SPEAR trial, the commercial and therapeutic potential of picoplatin, and the Company's product development and regulatory strategies. Actual results and events may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties inherent in the Company's business, including the potential safety, efficacy and commercial viability of picoplatin; the risk that the Company's additional analyses of data from clinical trials of picoplatin may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted trials; the receipt and timing of FDA and other regulatory approvals and actions; the Company's anticipated future operating losses, need for future capital and ability to obtain future funding or enter into strategic partnerships to support the continued development of picoplatin; the Company's ability to retain key personnel; competition from third parties; the Company's ability to preserve and protect its intellectual property rights; the Company's dependence on third-party manufacturers, suppliers and other contractors; 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, 2009. 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.
(1) American Cancer Society, Detailed Guide: Lung Cancer - Small Cell 2009, IntrinsiQ 2008
|SOURCE Poniard Pharmaceuticals, Inc.|
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