Poniard Pharmaceuticals Announces Final Top-Line Results From Phase 1 Trial Demonstrating Positive Bioavailability With Oral Picoplatin
SOUTH SAN FRANCISCO, Calif., Nov. 6 /PRNewswire-FirstCall/ — Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced top-line results from its Phase 1 clinical trial of an oral formulation of picoplatin in patients with solid tumors showing that picoplatin achieves linear and dose-dependent plasma exposure when given by the oral route. The results demonstrated that exposure to orally administered picoplatin was linear at doses below 200 mg, and that maximum exposure to orally administered picoplatin was achieved at doses of 200 mg or greater indicating sufficient bioavailability to support further clinical studies.
“Achieving sufficient bioavailability with oral picoplatin is extremely encouraging and supports further clinical development of an oral formulation of the drug, as it may provide a more convenient, flexible dosing routine for patients who would benefit from picoplatin,” said Robert De Jager, M.D., chief medical officer of Poniard. “Orally administered picoplatin may be desirable for cancer patients receiving radiation therapy and in combination with other oral therapies.”
Phase 1 Study Design and Results
Poniard’s randomized, open-label, dose-ranging Phase 1 study was conducted at clinical sites in the United States. The trial compared the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin administered intravenously in patients with advanced solid tumor malignancies. Bioavailability refers to the fraction of an administered dose of an unchanged drug that reaches systemic circulation. In the first part of this two-part trial, patients with advanced solid tumor malignancies were randomized to a single dose of either intravenous (120 mg/m squared) or oral picoplatin (200, 300 or 400 mg). Four weeks later, they were crossed over to a second single picoplatin dose administered via the alternative route. In the second part of the trial, patients received only a single oral dose of picoplatin (including doses of 50 and 100 mg).
Results showed that oral picoplatin can achieve oral bioavailability of up to 44 percent in the doses tested in the first arm. Results also showed that picoplatin oral bioavailability is linear, and maximum exposure to orally administered picoplatin was achieved at doses of 200 mg or greater. Additionally, following four weeks of dosing with either oral or intravenous picoplatin, only background levels of circulating platinum could be detected, suggesting no drug accumulation between dosing cycles.
There were no differences in pharmacokinetics observed, and all doses were well tolerated with no serious adverse events related to treatment noted following the oral dose. No myelosuppression occurred after oral dosing.
Poniard expects to present additional data from the trial at scientific meetings during 2009.
Picoplatin has an improved safety profile relative to existing platinum- based cancer therapies and is designed to overcome platinum resistance associated with chemotherapy in solid tumors. It is being studied in multiple cancer indications, combinations and formulations. 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.
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 a Phase 2 clinical trial in patients with metastatic colorectal cancer and in an ongoing Phase 2 clinical trial in patients with hormone-refractory prostate cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. The oral formulation of picoplatin has the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by any regulatory authority for use in humans.
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 business objectives and strategic goals, drug development plans, timing and results of clinical trials and the potential safety and efficacy of its 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 Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of 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, which will be filed with the SEC on or about November 7, 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) 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved. Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
Poniard Pharmaceuticals, Inc.
CONTACT: Brendan Doherty of Poniard Pharmaceuticals CorporateCommunications, +1-650-745-4425, email@example.com
Web site: http://www.poniard.com/