- Pharmacologic Data Presented at American Association for Cancer Research's 100th Annual Meeting 2009 -
SOUTH SAN FRANCISCO, Calif. and DENVER, April 21 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced the presentation of final data from a Phase 1 clinical study of an oral formulation of picoplatin in patients with solid tumors. Results showed that the bioavailability of oral picoplatin is nearly 100 percent at doses of 50 mg and 100 mg, indicating sufficient bioavailability to support further clinical development.
Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent in clinical development to treat a variety of solid tumors. It was designed to overcome platinum resistance of the tumor, which remains a medical challenge for oncologists and patients, whose therapeutic options become limited. Poniard is currently evaluating an intravenous formulation of picoplatin in a pivotal Phase 3 trial in patients with small cell lung cancer (SCLC) and in Phase 2 trials in metastatic colorectal cancer (CRC) and metastatic castration-resistant prostate cancer (CRPC).
"The results of the Phase 1 trial demonstrating the oral bioavailability of picoplatin support the continued development of an oral formulation for multiple tumor indications," said Robert De Jager, M.D., chief medical officer of Poniard. "We believe that oral picoplatin may offer opportunities for studies in new indications and in combinations with other chemotherapeutics or with radiation therapy. The administration options for oral picoplatin may provide more convenience to cancer patients and could enable the potential of multiple combination therapies."
The picoplatin data were presented today in a poster session (abstract #3594) during the American Association for Cancer Research's 100th Annual Meeting 2009 at the Colorado Convention Center in Denver.
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 to 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 mg, 300 mg or 400 mg). Four weeks later, they received a second single picoplatin dose administered via the other route. In the second part of the trial, patients received only a single oral dose of picoplatin (including doses of 50 mg and 100 mg).
Final results showed that oral picoplatin achieved oral bioavailability of nearly 100 percent at doses of 50 mg and 100 mg. No meaningful differences in pharmacokinetics were observed between the two formulations. All doses of the oral dose were well tolerated. No serious adverse events related to treatment were noted following administration of the oral dose.
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have received picoplatin. Results obtained to date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors. It is being studied in multiple cancer indications, treatment combinations and by two routes of administration.
Poniard is currently evaluating the efficacy and safety of picoplatin in SCLC in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. The Company reached its enrollment target in this international, multi-center, randomized, controlled trial in March 2009. Poniard is also evaluating picoplatin in two Phase 2 clinical trials -- one in patients with metastatic CRC and the other in patients with castration-resistant (or hormone-refractory) prostate cancer.
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 results of clinical trials, business objectives and strategic goals, drug development plans, the potential safety and efficacy of its products in development and commercialization strategy. 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. 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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|SOURCE Poniard Pharmaceuticals, Inc.|
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