Poniard Pharmaceuticals Announces Progression-Free Survival Data From Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer
- New Progression-Free Survival, Disease Control and Neurotoxicity Data To Be Presented at 2009 ASCO Annual Meeting Continue to Support Picoplatin as a Neuropathy-Sparing Alternative to Oxaliplatin for First-Line Treatment of Colorectal Cancer -
- Poniard Management Team to Host Analyst and Investor Briefing to Discuss Data on
“Oxaliplatin given as part of the FOLFOX-based regimen is the current standard of care for metastatic colorectal cancer, but is associated with severe neuropathy at increasing cumulative doses approaching 800 mg/meter squared. This significant side effect may cause patients extreme pain, numbness and weakness, which is often long-lasting and, in many cases, requires patients to discontinue treatment,” said
Picoplatin, the Company’s lead product candidate, is a new generation platinum-based chemotherapy agent. Clinical studies to date suggest that picoplatin has an improved safety profile. It is in clinical development for multiple indications and combinations and in two formulations. The picoplatin CRC data will be presented at the American Society of Clinical Oncology’s 2009 Annual Meeting in
The randomized, controlled Phase 2 trial is evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who have not received prior chemotherapy. The trial is comparing the safety and efficacy (assessed by objective tumor response, PFS and overall survival) of intravenous picoplatin given once every four weeks in combination with bi-weekly 5-fluorouracil and leucovorin (the FOLPI regimen) with oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen.
The Phase 2 data, scheduled for presentation at the ASCO Annual Meeting, demonstrated that:
- The median PFS in the intent-to-treat population was 6.8 months for patients randomized and treated with the picoplatin-containing FOLPI regimen compared with 7.0 months for those who received modified FOLFOX-6, containing oxaliplatin.
- Of the 51 patients in the FOLPI treatment arm, 75 percent achieved disease control (defined as complete response, partial response or stable disease); two patients with a complete response, nine patients with a partial response and 27 patients with stable disease. In the FOLFOX treatment arm of 50 patients, 76 percent achieved disease control; three patients with a complete response, 11 patients with a partial response and 24 patients with stable disease.
- Only 29 percent of the patients who received FOLPI showed evidence of neurotoxicity compared with 60 percent of patients treated with FOLFOX. In addition, 16 percent of FOLFOX-treated patients exhibited severe (Grade 3/4) neurotoxicity, whereas no FOLPI-treated patients showed evidence of severe neurotoxicity. Three different measurements of neuropathy were statistically significant for FOLPI as a potential neuropathy-sparing alternative to FOLFOX (p<0.0019).
- With regard to hematologic toxicities, thrombocytopenia and neutropenia were more frequent and severe with the FOLPI regimen compared with FOLFOX. However, only one episode of febrile neutropenia and no bleeding complications have been observed to date. In addition, 83 percent of the planned picoplatin dose of 150 mg/meter squared was able to be delivered monthly in the 51 patients treated in the FOLPI treatment arm of the trial.
- Nonhematologic adverse events, including gastrointestinal toxicity, were similar between the treatment groups, with the exception of alopecia, which occurred more frequently with FOLPI.
“We continue to be encouraged by these interim, proof-of-concept Phase 2 safety and efficacy results, which suggest the potential of picoplatin in FOLPI as a neuropathy-sparing therapeutic alternative to the use of FOLFOX for the first-line treatment of metastatic colorectal cancer,” said
Analyst and Investor Briefing
Poniard will host an investor event in
About Colorectal Cancer
CRC is the third most common cancer in both American men and women, and the third leading cause of cancer death in the U.S. In 2008, an estimated 148,810 new cases of colon and rectal cancer were expected to be diagnosed in the U.S., with an estimated 49,960 deaths.(1) A FOLFOX-containing regimen is the current standard of care but is associated with a high incidence of neuropathy. Discontinuation of oxaliplatin from FOLFOX is recommended by the National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology (v.2.2009) after three months of therapy or sooner if significant neurotoxicity (> Grade 3) occurs, with other drugs maintained until the time of tumor progression.
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have received picoplatin. To date, results suggest that hematologic events are severe but manageable. Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less severe 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 and combinations 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
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
(C) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
(1) American Cancer Society, Cancer Facts and Figures 2008
SOURCE Poniard Pharmaceuticals, Inc.