SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 13 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that an analysis of data from its ongoing Phase 1 clinical trial of an oral formulation of picoplatin in patients with solid tumors showed that picoplatin can achieve oral bioavailability of up to 44 percent in doses tested to date. These data are consistent with findings from preclinical oral bioavailability studies of picoplatin. The Company also announced findings from a preclinical study demonstrating that picoplatin retains its activity in small cell lung cancer (SCLC) cell lines made resistant by treatment with cisplatin, carboplatin or oxaliplatin. Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations. The data were presented today in a poster session during the Annual Meeting of the American Association for Cancer Research (AACR) in San Diego.
"The data from our ongoing clinical study supports further development of an oral formulation of picoplatin," said Robert De Jager, M.D., chief medical officer of Poniard. "This includes the possible use in combination with other oral cancer therapies and radiation which would provide a novel treatment paradigm for platinum-based cancer therapy."
Additional results from the Phase 1 study presented at the AACR Annual Meeting showed that four weeks after picoplatin dosing -- by either the oral or intravenous route -- only background levels of circulating platinum could be detected, suggesting no drug accumulation between dosing cycles. All doses of the investigational drug were well tolerated. No serious adverse events related to treatment were observed following oral dosing.
In the preclinical study presented at the AACR Annual Meeting, Poniard scientists generated resistant SCLC cell lines by repeatedly exposing the cells to cisplatin, carboplatin, oxaliplatin and picoplatin. They not only found it difficult to obtain picoplatin resistant cells but also found that picoplatin remained effective in SCLC cells previously treated with the other platinum agents.
According to Dr. De Jager, "The data supports the possible use of picoplatin in tumors with acquired platinum resistance resulting from previous treatment with cisplatin, carboplatin or oxaliplatin. The use of platinum-resistant biomarkers may help to identify those patients who would most benefit from picoplatin treatment."
Ongoing Phase 1 Study of Oral Picoplatin
Poniard's randomized, open-label, dose-ranging Phase 1 study is being conducted at clinical sites in the United States. The trial is comparing 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. Based on promising findings, Poniard has expanded the study to include additional dose levels to enhance data analysis. The Company expects to present additional data from the trial at scientific meetings this year.
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 SCLC. This registrational 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. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials for the treatment of hormone-refractory prostate cancer and metastatic colorectal 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. Picoplatin, the Company's lead platform product candidate, is a new generation platinum therapy with an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and hormone-refractory prostate cancers, as well as a clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by any regulatory authority for use in humans. 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, design, conduct 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. 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.
Abstract #209. Yee L, Sharma S, Breitz H, Karlin D, Phillips A, Houston S, Saleh M. A phase 1 randomized crossover oral picoplatin bioavailability pharmacokinetics and pharmacodynamics study. To be presented at the Annual Meeting of the American Association for Cancer Research, April 13, 2008, San Diego.
Abstract #713. Parham C, Shocron E, McMahon G, Patel N. Picoplatin overcomes resistance in small cell lung cancer cell lines treated with other platinum-based chemotherapeutics. To be presented at the Annual Meeting of the American Association for Cancer Research, April 13, 2008, San Diego.
SOURCE Poniard Pharmaceuticals, Inc.