DiagnosticsPoniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, announced results from a Phase 1 cardiac safety study of picoplatin, a new generation platinum-based chemotherapy agent and the Company"s lead product candidate. The Company worked collaboratively with the U.S. Food and Drug Administration (FDA) to design this study, which is required for new chemical entities.
This study evaluated the cardiac safety of picoplatin by determining its effect on the cardiac QT/QTc interval by using time-matched pharmacokinetics and electrocardiograms (ECGs). A total of 45 patients with advanced solid malignancies received 150 mg/m2 picoplatin. The trial was conducted at seven clinical sites in the United States. Results showed no clinical cardiac-related events. In addition, no evidence of a clinically relevant trend in any ECG parameter was demonstrated.
"With these new picoplatin safety data, we continue to make progress toward our goal of initiating the filing in 2009 of a New Drug Application for picoplatin as a second-line treatment for small cell lung cancer, with approval and commercialization targeted for 2010," said Robert De Jager, M.D., chief medical officer of Poniard. "More than 1,100 cancer patients have received picoplatin in clinical studies to date. Additional safety and anticipated efficacy data from our ongoing Phase 3 SPEAR study will provide a strong database to support the NDA filing."
The Company plans to present data from the Phase 1 cardiac safety trial at a medical conference later this year.
About Picoplatin
Picoplatin is a new generation platinum-based chemotherapy 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. Results 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.
Poniard is currently evaluating the efficacy and safety of picoplatin in small cell lung cancer in a pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial that is being conducted under a Special Protocol Assessment with the FDA. The Company reached its enrollment target in this international, multi-center, randomized, controlled trial in March 2009. Poniard is also evaluating picoplatin in a Phase 2 clinical trial in patients with colorectal cancer and in a Phase 2 clinical trial in patients with castration-resistant prostate cancer. Oral picoplatin has been 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.
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This release contains forward-looking statements, including statements regarding the Company"s business objectives and strategic goals, drug development plans, and the potential safety and efficacy of its products in development, and commercialization. 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 and its Quarterly Report on Form 10-Q for the period ended March 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.
Poniard Pharmaceuticals, Inc