Poniard Pharmaceuticals Announces Final Picoplatin Data from Phase 2 Small Cell Lung Cancer Trial Demonstrating Survival Benefit- Final Safety and Efficacy Data Presented at 1st IASLC-ESMO European Lung Cancer Conference -
SOUTH SAN FRANCISCO, Calif., April 23, 2008 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that final efficacy results from its Phase 2 clinical trial of picoplatin confirming previously announced interim results showing a survival benefit in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. The median overall survival rate was 27 weeks and both this efficacy and the safety profile compares favorably with current medical treatments which often include palliative best supportive care. Best supportive care has been shown previously to have a median overall survival of 14 weeks and is the comparator arm for the ongoing randomized Phase 3 trial to evaluate picoplatin treatment in this patient setting. The final data were presented during a poster discussion session at the 1st European Lung Cancer (IASLC) and the European Society for Medical Oncology (ESMO).
"These final Phase 2 data show that picoplatin extended survival in patients with small cell lung cancer refractory to, or relapsing within 6 months of first-line platinum based chemotherapy," said Robert De Jager, M.D., chief medical officer of Poniard. "Based on promising results from this trial, we initiated our ongoing Phase 3 SPEAR trial in small cell lung cancer. We are targeting commercialization of picoplatin for use in SCLC in 2010. We are committed to developing picoplatin as a new generation chemotherapy agent addressing multiple indications, combinations and formulations."
Final results from patients in the international, open-label, multi-center Phase 2 trial were presented. An analysis of 62 deaths in 77 patients indicated a median overall survival of 27 weeks following picoplatin treatment administered once every 3 weeks. The most common side effects found in this present study were hematologic, including thrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment- related deaths occurred in this study. In addition, quality of life was preserved in the group of patients receiving picoplatin assessed every 3 weeks with Lung Cancer Symptom Scale (LCSS).
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 and 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 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. 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 Phase 1 clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by any regulatory authority for use in humans.
This release contains forward-looking statements, including statements regarding the Company's 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: April 2008