Poniard Pharmaceuticals Announces Clinical Data From Picoplatin Oral Phase 1 to Be Presented at the American Association of Cancer Research Annual Meeting- Additional data presentation on picoplatin overcoming platinum resistance in small cell lung cancer -
SOUTH SAN FRANCISCO, Calif., March 19, 2008 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that preliminary data from a Phase 1 trial of an oral formulation of picoplatin in patients with solid tumors will be presented at the 2008 American Association for Cancer Research meeting to be held from April 12-16 in San Diego, CA. In addition, preclinical data of picoplatin overcoming platinum resistant small cell lung cancer cells in platinum resistant cell lines will also be presented at a separate poster presentation.
Details are as follows: -- A Phase 1 randomized crossover picoplatin bioavailability pharmacokinetics and pharmacodynamics study. Abstract #209, Session ID: Clinical Research 1; Yee L, Sharma S, Breitz H, Karlin D, Phillips A, Houston S, Saleh M. General Poster Session Sunday April 13, 8:00 AM PT. -- Picoplatin overcomes resistance in small cell lung cancer cell lines treated with other platinum-based chemotherapeutics. Abstract #713, Session ID: Experimental Molecular Therapeutics 3; Parham C, Shocron E, McMahon G, Patel N. General Poster Session Sunday April 13, 8:00 AM PT.
Picoplatin is the Company's lead product candidate under investigation in three clinical trials.
Picoplatin is a chemotherapeutic agent that has an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumors. Picoplatin has been evaluated in more than 750 patients and has anti-tumor activity in multiple indications with less severe kidney or nerve toxicity 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 registrational trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and is evaluating overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic Colorectal Cancer (mCRC). Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. Picoplatin has not been approved by 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.
This release contains forward-looking statements, including statements regarding the Company's business objectives and strategic goals, drug development plans, 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. 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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Posted: March 2008