SOUTH SAN FRANCISCO, Calif., May 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced that the independent Data Monitoring Committee (DMC), after review of available information regarding the efficacy, safety and quality of trial conduct, recommends that the SPEAR (Study of Picoplatin Efficacy After Relapse) trial continue. The international, pivotal Phase 3 trial is evaluating the efficacy and safety of picoplatin in patients with small cell lung cancer (SCLC) who were refractory to or progressed within six months of first-line therapy.
"The recommendation by the DMC to continue our SCLC registration trial represents another milestone in the development of picoplatin as a potential new treatment option for SCLC patients," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We are encouraged by the continued progress of the trial and remain on track to complete the clinical data analysis to support the initiation of a New Drug Application with the U.S. Food and Drug Administration this year."
About the Independent DMC
The DMC is an independent, multi-disciplinary group consisting of clinicians and a biostatistician that, collectively, have experience in the management of patients with SCLC and in the conduct and monitoring of randomized clinical trials. The DMC is responsible for safeguarding the interests of the SPEAR trial participants, assessing the safety and efficacy of the interventions during the trial, and for monitoring the overall conduct of the clinical trial. To contribute to enhancing the integrity of the trial, the DMC will also review whether Best Supportive Care (BSC) is qualitatively or quantitatively adequate or inadequate within and between the treatment arms.
Phase 3 SPEAR Trial Design and Special Protocol Assessment (SPA)
SPEAR is an international, multi-center, randomized, controlled, pivotal Phase 3 trial of picoplatin in patients with SCLC who were refractory to or progressed within six months of first-line, platinum-containing chemotherapy. Patients are randomized two to one to receive picoplatin plus BSC verses BSC alone. The initial dose of picoplatin is 150 mg/m squared administered as an intravenous infusion once every three weeks. BSC is designed in accordance with the National Comprehensive Cancer Network's guidelines and includes analgesics, radiation therapy for painful bone metastases, brain metastases or relief of obstructive symptoms from lesions in the chest, nutritional support and treatment of anemia, dyspnea, infections, paraneoplastic syndromes, anxiety or other clinical problems. The primary endpoint of SPEAR is overall survival. Secondary endpoints include overall response rate, progression-free survival, disease control rate and duration of response. The enrollment target for SPEAR was reached and a total of 401 patients were enrolled from over 100 sites worldwide as of March 31, 2009.
The SPEAR study design is agreed to by the U.S. Food and Drug Administration (FDA) under a SPA. Fast Track designation was granted by the FDA and an Orphan Drug designation was granted by the FDA and European Medicines Agency. The study is 90 percent powered to show a 33 percent reduction in risk in overall survival for the treatment arm compared to BSC alone (hazard ratio = 0.67) (p < 0.05). Our Phase 2 study in resistant or refractory disease or patients who relapsed within 180 days of first-line platinum therapy, demonstrated that patients treated with picoplatin showed a median overall survival of 27 weeks(1). Historical data indicates that BSC treatment of patients with recurrent SCLC have a median overall survival of 14 weeks(2). Based on patient enrollment data, the Company believes that overall survival data will be available from the SPEAR trial in the second half of 2009.
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, in the U.S. in 2008 an estimated 32,000 new cases of SCLC were expected to be diagnosed and 52,000 SCLC patients were treated with therapy (American Cancer Society, Cancer Facts and Figures 2009). Patients with SCLC have few treatment options and a poor prognosis. Effective second-line treatment for SCLC is a major unmet need.
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have received picoplatin. Results obtained to date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors. It is being studied in multiple cancer indications, treatment combinations and by two routes of administration.
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 chemotherapy. To date, clinical studies suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome 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 SCLC and Phase 2 trials in metastatic colorectal and castration-resistant (hormone refractory) prostate cancers. The Company also is conducting a clinical trial of oral picoplatin in solid tumors. 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 and commercialization strategy, the timing and results of clinical trials and the potential safety and efficacy of the Company's 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 current distressed economic and financial market, 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, 2008 and its Quarterly Report on Form 10-Q for the period ended March 31, 2009, which will be filed with the SEC on or about May 11, 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.
(C) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
(1) Eckardt JR, Bentsion DL, Lipatov ON, et al. Phase II Study of Picoplatin as Second-Line Therapy for Patients With Small-Cell Lung Cancer. JCO 2009;27:2046-2051
(2) O'Brien, M. et al. J Clin Oncol. 2006 Dec ;24(34):5441-7
|SOURCE Poniard Pharmaceuticals, Inc.|
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