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Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, announced the presentation of new efficacy and safety data from its ongoing Phase 2 clinical trial of picoplatin in combination with docetaxel and prednisone as first-line therapy for metastatic castration-resistant prostate cancer (CRPC). Results showed that the combination is active as first-line therapy for metastatic CRPC (also known as hormone-refractory prostate cancer) as demonstrated by prostate specific antigen (PSA) levels, time to PSA progression and radiologic response rates. Results also continue to show that picoplatin can be safely administered with full-doses of docetaxel and prednisone, the standard treatment for CRPC.
"The time to PSA progression data along with high rates of PSA response in this ongoing Phase 2 trial are encouraging and suggest potential clinical benefit when picoplatin is combined with docetaxel and prednisone as a first-line therapy for patients with CRPC," said William K. Oh, M.D., clinical director of the Lank Center for Genitourinary Oncology at the Dana Farber Cancer Institute and associate professor, Harvard Medical School. "While awaiting final data from this trial, I believe that the updated results reported to date warrant consideration of a Phase 3 clinical trial to compare picoplatin with docetaxel and prednisone to docetaxel and prednisone alone in metastatic CRPC patients, a group of men with limited therapeutic choices."
The picoplatin data will be presented in a poster session on Friday, February 27, at 11:45 a.m. Eastern Time (abstract #186/poster #A38) during the American Society of Clinical Oncology's (ASCO) 2009 Genitourinary Cancers Symposium in Orlando, Fla. Picoplatin, the Company's lead product candidate, is a new generation platinum-based chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations for the treatment of solid tumors.
Phase 2 CRPC Trial Design and Results to Date
Patient enrollment in the ongoing Phase 2 trial of picoplatin in patients with metastatic CRPC was completed in December 2007. The trial enrolled 30 patients with metastatic CRPC who had not received prior chemotherapy. The objective of the study is to evaluate the efficacy and safety of intravenous picoplatin (120 mg/m squared) administered every three weeks in combination with full doses of docetaxel (75 mg/m squared) with daily prednisone (5 mg) as a first-line treatment. PSA response (defined as a PSA reduction of at least 50 percent from baseline maintained for at least four weeks) is the primary endpoint; secondary endpoints include safety, radiologic response, time to progression and overall survival.
The latest trial findings, scheduled for presentation at the ASCO 2009 GU Symposium, demonstrated that:
-- Reductions of PSA levels of at least 50 percent were achieved in 21 of 27 (78 percent) evaluable patients who received picoplatin in combination with docetaxel and prednisone. In contrast, data from published literature report PSA responses of approximately 45 percent in patients who received docetaxel/prednisone.
-- To date, the median time to PSA progression is 8.5 months with picoplatin in combination with docetaxel and prednisone.
-- Radiologic responses evaluated using RECIST (Response Evaluation Criteria in Solid Tumors; an internationally recognized measure of disease progression) in patients with measureable disease showed an overall response rate of 8 percent (one partial response in 13 patients with measureable disease) and a 54 percent disease control rate (six of 13 patients with measureable disease). In comparison, published literature reports overall response rates of 8 to 12 percent in patients treated with docetaxel alone.
-- These data indicate that picoplatin can be safely administered with full-dose docetaxel. Neutropenia was the main hematologic toxicity. Thrombocytopenia was less severe and less frequent with picoplatin administered in combination with docetaxel compared with picoplatin administered alone.
These findings confirm and extend earlier Phase 2 results presented at the 20th European Organization for Research and Treatment of Cancer - National Cancer Institute - American Association for Cancer Research (EORTC-NCI-AACR) Symposium on "Molecular Targets and Cancer" in Geneva, Switzerland, in October 2008.
"The encouraging PSA response rates, time to PSA progression and radiologic responses rates, combined with the promising safety results observed to date, support further development of picoplatin in combination with docetaxel and prednisone in advanced prostate cancer patients," said Robert De Jager, M.D., chief medical officer of Poniard. "We continue to collect and analyze data from this trial and expect to present updated clinical data, including time to disease progression and overall survival, at medical conferences later this year."
About Picoplatin
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. 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 by two routes of administration.
In addition to the Phase 2 clinical trial in metastatic CRPC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registration trial currently is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. Picoplatin is also being evaluated in an ongoing Phase 2 clinical trial in patients with metastatic colorectal cancer. Oral picoplatin is 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 to date, 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, 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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