SOUTH SAN FRANCISCO, Calif., March 25 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that it has reached its enrollment target of 400 patients in the SPEAR (Study of Picoplatin Efficacy After Relapse) trial. This global, pivotal Phase 3 trial is evaluating the efficacy and safety of picoplatin in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. Patients have been enrolled at more than 100 clinical trial sites in 16 countries in Europe, South America and Asia.
"Completion of patient enrollment in our pivotal Phase 3 SPEAR trial represents an important milestone for Poniard. We accomplished this ahead of internal projections, which allows us to keep on schedule to complete the clinical data analysis and initiate the filing of a rolling New Drug Application with the U.S. Food and Drug Administration for picoplatin in SCLC this year," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We believe that picoplatin will provide a survival benefit for SCLC patients who have failed platinum-based therapy consistent with survival data we have previously generated in two independent Phase 2 trials. We also expect the data will show that picoplatin overcomes resistance in patients treated with current platinum-based chemotherapies. This would be a new use for a platinum chemotherapy agent. We are also continuing to analyze additional clinical data from our picoplatin Phase 2 trials in first-line treatment for metastatic colorectal and prostate cancers and will report on them later this year."
"We are pleased to have completed trial enrollment ahead of schedule," said Robert De Jager, M.D., chief medical officer of Poniard. "The data from this trial is event-driven and we expect that the overall survival data from the SPEAR trial will show a significant survival advantage compared to patients who receive best supportive care alone. We believe this is the first important step to provide a new treatment option for the many SCLC patients who do not achieve clinical benefit from current first-line therapies. This would be a significant accomplishment for this aggressive tumor type that has very few FDA-approved drugs."
SPEAR Trial Design
The international, multi-center, randomized, controlled, pivotal Phase 3 SPEAR trial compares picoplatin plus best supportive care, to best supportive care alone, to evaluate the efficacy and safety of picoplatin after relapse. Best supportive care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side effects of palliative cancer treatments. The primary efficacy endpoint is overall survival. Overall response rates, progression-free survival and disease control are also being evaluated.
The SPEAR trial is being conducted under the review of an independent Data Monitoring Committee, which assesses use of best supportive care to ensure balance in both arms of the trial, as well as the use of picoplatin and its safety in the treatment arm. The trial is also being conducted under a Special Protocol Assessment (SPA) developed with the FDA.
Poniard has received Orphan Drug and Fast Track designations for picoplatin for the second-line treatment of refractory or resistant SCLC from the FDA, and Orphan Drug designation from the European Commission for medicinal product status for SCLC.
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date indicate that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have been treated with 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.
In addition to the Phase 3 SPEAR trial in SCLC, picoplatin is also being evaluated in two ongoing Phase 2 clinical trials The first is evaluating the safety and efficacy of picoplatin in patients with metastatic colorectal cancer and the second in patients with castration-resistant (or hormone-refractory) prostate cancer. Oral picoplatin is also being evaluated in a Phase 1 clinical trial in solid tumors.
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 results of clinical trials, business objectives and strategic goals, drug development plans, 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 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. 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.
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Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
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