SOUTH SAN FRANCISCO, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today provided an overview of its 2010 corporate, clinical and regulatory goals for picoplatin.
"Our focus in 2010 is to secure a strategic partnership to continue the development of picoplatin as a preferred platinum agent in the treatment of solid tumor malignancies. We believe that current data from approximately 1,100 patients treated with picoplatin, including data from Phase 2 trials of picoplatin in colorectal, prostate and ovarian cancers, indicate that picoplatin would be a valuable addition to potential partners with marketed and development stage oncology products," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "Throughout the first half of this year, we plan to a have discussions with the U.S. Food and Drug Administration regarding a regulatory path forward for picoplatin in small cell lung cancer. We expect to submit efficacy and safety data from the Phase 3 SPEAR trial for potential presentation at the American Society of Clinical Oncology 2010 Annual Meeting in June."
Poniard plans to work toward the achievement of the following goals for picoplatin in 2010:
Picoplatin for the Treatment of Small Cell Lung Cancer * Complete discussions with the U.S. Food and Drug Administration (FDA) regarding a regulatory path forward for picoplatin in small cell lung cancer (SCLC). The Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial enrolled 401 patients and evaluated intravenous picoplatin in SCLC patients who failed or relapsed following first-line platinum therapy within six months following initial treatment with a platinum-based therapy. While the data analysis showed that the study did not meet the primary endpoint of overall survival, the data suggest a potential trend toward a survival advantage in SCLC patients treated with picoplatin and best supportive care compared to best supportive care alone. The intent-to-treat analysis was based on 321 patient deaths and showed a hazard ratio of 0.82 and a p value of 0.089. * Submit SPEAR efficacy and safety data for potential presentation at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting taking place June 4-8, 2010 in Chicago. Picoplatin for the Treatment of Colorectal Cancer * Present additional data from the Company's Phase 2 trial evaluating picoplatin as a neuropathy-sparing agent compared to oxaliplatin in the first-line treatment of patients with metastatic colorectal cancer (CRC) on Sunday, January 24, 2010 at the ASCO 2010 Gastrointestinal Cancers Symposium in Orlando, Fla. This randomized, controlled trial is being conducted with 101 metastatic CRC patients who have not received prior chemotherapy and is comparing the safety, including the incidence and severity of neuropathy, and efficacy, measured by overall survival, progression-free survival and disease control, 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 modified FOLFOX-6 regimen. Data to date have shown a statistically significant reduction in neurotoxicities with the use of picoplatin in the FOLPI regimen compared with the use of oxaliplatin in the FOLFOX regimen (p<0.0019). In addition, picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5- fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity as assessed by progression-free survival (PFS) and disease control. Picoplatin for the Treatment of Prostate Cancer * Present additional data from the Company's Phase 2 trial of picoplatin in patients with metastatic castration-resistant prostate cancer (CRPC) at the ASCO 2010 Genitourinary Cancers Symposium on March 5, 2010 in San Francisco. 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 CRPC who have not received prior chemotherapy. Prostate-specific antigen (PSA) response (defined as a PSA reduction of at least 50 percent from baseline for 4 weeks) is the primary endpoint of the study. Secondary endpoints include safety, disease control, time to progression and overall survival. Data to date indicate that picoplatin, in combination with docetaxel and prednisone, shows promising efficacy and is well tolerated as first-line therapy for metastatic CRPC. Efficacy is assessed by several endpoints, including reductions in PSA levels, disease control, and PFS. Safety data to date indicate that picoplatin can be administered every three weeks for up to 10 cycles concurrently with full doses of docetaxel and prednisone which is the current standard first-line treatment for metastatic CRPC. In addition, no neurotoxicity has been observed in this study to date.
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 easily combined and safely administered with other currently marketed 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.
Poniard has evaluated intravenous picoplatin in the treatment of SCLC in its Phase 3 SPEAR trial. This trial did not meet its primary endpoint of overall survival, and the Company plans to meet with the FDA to discuss a potential regulatory path forward for picoplatin in this indication. Poniard is also evaluating picoplatin in a Phase 2 clinical trial in patients with metastatic CRC and in a Phase 2 clinical trial in patients with metastatic CRPC. Final results of the Company's Phase 1 cardiac safety trial and the Phase 1 trial of an oral formulation of picoplatin were presented in 2009.
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 about the Company's goals for 2010, including statements interpreting the results of clinical trials to date, the potential safety and efficacy of its picoplatin product candidates, the attractiveness of picoplatin to potential strategic partners, and the Company's regulatory and partnering strategies. 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 inherent in the Company's business, including, but not limited to, the potential safety, efficacy and commercial viability of the Company's picoplatin product candidates; 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 results and timing of the Company's discussions with the FDA regarding potential regulatory pathways for picoplatin in SCLC and other indications; the Company's anticipated operating losses, need for future capital and ability to obtain future funding; the Company's ability to attract and retain key personnel and enter into strategic partnerships on favorable terms, or at all; 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; the receipt and timing of any FDA and other required regulatory approvals; 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 September 30, 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.
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