SOUTH SAN FRANCISCO, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. today provided an overview of its 2010 corporate, clinical and regulatory goals for picoplatin.
Poniard plans to work toward the achievement of the following goals for picoplatin in 2010:
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.
Forward-Looking Statement
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.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
Poniard Pharmaceuticals, Inc.
