- Safety and Tumor Response Data from Dose-Escalation Study 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 dose-escalation study of picoplatin in patients with metastatic colorectal cancer (CRC). Results demonstrated that picoplatin can be safely administered in combination with 5-fluorouracil and leucovorin (FOLPI) as a first-line option for CRC. Based on the safety data as well as the promising clinical activity observed in this trial, Poniard initiated a randomized, controlled, proof-of-concept Phase 2 trial to evaluate picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC. Patient enrollment was completed in May 2008.
"Several treatment options for metastatic CRC have been introduced in the last decade and have resulted in enhanced survival when administered as a first-line treatment. However, these treatments can cause serious side effects, including severe neuropathies that prevent patients from participating in routine daily activities and may lead to discontinuing therapy," said Robert De Jager, M.D., chief medical officer of Poniard. "We are encouraged by these preliminary results, which continue to show that picoplatin given once every four weeks as part of the FOLPI regimen is associated with less frequent and severe neurotoxicity than oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen; both regimens have similar anti-tumor activity in first-line metastatic CRC. We are continuing to observe the study participants and look forward to presenting initial progression-free survival data at the 2009 American Society of Clinical Oncology Annual Meeting."
The picoplatin data were presented today in a poster session (abstract #3578) during the American Association for Cancer Research's 100th Annual Meeting 2009 at the Colorado Convention Center in Denver. Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent in clinical development to treat multiple types of cancer. It is designed to overcome platinum resistance associated with chemotherapy in solid tumors.
Phase 1 CRC Study Design and Results
In the Phase 1 study, 73 patients received the FOLPI regimen with picoplatin administered either every two or every four weeks to evaluate safety and identify the maximum tolerated dose and the optimal schedule of FOLPI administration. Patients received a total picoplatin exposure of between 85 mg/m squared and 1,871 mg/m squared.
None of the patients who received picoplatin exhibited severe neuropathy (Grade 3 or 4), as is commonly seen in metastatic CRC patients treated with the FOLFOX regimen at cumulative oxaliplatin doses above 800 mg/m squared. In addition, none of the patients who received picoplatin exhibited severe (Grade 3/4) nephrotoxicity (kidney toxicity) or ototoxicity (hearing toxicity).
The dose limiting toxicities for both the every-four-week regimen and the every-two-week regimen were neutropenia and thrombocytopenia, which were reversible. The maximum tolerated dose of picoplatin in the every-four-week FOLPI schedule was 150 mg/m squared. 150 mg/m squared for the every-four-week FOLPI schedule and 85 mg/m squared for the every-two-week FOLPI schedule achieved 80 percent of the planned dose and support further clinical studies at these doses and schedules. The 150 mg/m squared dose and schedule was selected for evaluation in the ongoing randomized Phase 2 trial.
Of 18 evaluable patients who received the every-four-week FOLPI regimen, 67 percent achieved disease control (partial response and stable disease). Of 55 evaluable patients who received the every-two-week FOLPI regimen, 75 percent achieved disease control.
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.
In addition to the Phase 2 clinical trial in CRC, Poniard is currently evaluating the efficacy and safety of picoplatin in small cell lung cancer in a 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 a Phase 2 clinical trial in patients with castration-resistant (or hormone-refractory) prostate cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors.
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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Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
|SOURCE Poniard Pharmaceuticals, Inc.|
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