- Findings Demonstrate Survival Benefit with Picoplatin as Second-Line Therapy for Small Cell Lung Cancer -
SOUTH SAN FRANCISCO, Calif., April 20 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that results of its Phase 2 clinical trial of picoplatin in patients with recurrent small cell lung cancer (SCLC) were published in the April 20, 2009, print issue of the Journal of Clinical Oncology(1). Picoplatin demonstrated a survival benefit in this open-label, multi-center Phase 2 trial of SCLC patients who failed prior platinum-containing first-line chemotherapy or who progressed within six months of first-line therapy. The median overall survival was 27 weeks and the median one-year survival rate was 17.6 percent in this patient population of mostly platinum-refractory and -resistant patients.
Poniard is currently evaluating the efficacy and safety of picoplatin in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) SCLC trial, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The Company reached its enrollment target in this international, multi-center, randomized, controlled trial in March 2009.
SCLC is the most aggressive lung cancer and tends to be widely disseminated by the time of diagnosis. The prognosis for patients with SCLC that has progressed despite chemotherapy is exceedingly poor regardless of stage. Effective second-line treatment for SCLC is a major unmet need. There is no standard chemotherapy for second-line platinum-refractory or -resistant SCLC.
"New treatments are desperately needed for patients with platinum-resistant and -refractory small cell lung cancer due to the rapid relapse of the disease and the slim chance that patients will experience long-term survival," said John Eckardt, M.D., lead author of the JCO publication, picoplatin clinical trial investigator, and chief medical officer of DAVA Oncology. "I am encouraged that picoplatin extended survival in this patient group and was generally well tolerated. Data from the Phase 3 SPEAR trial in the same patient population will further clarify the potential of picoplatin as a viable treatment for patients with this highly lethal type of cancer."
Phase 2 Study Design and Results
The open-label, multi-center Phase 2 trial was designed to confirm the clinical activity and safety of picoplatin as second-line therapy in patients with platinum-refractory disease or platinum-resistant or platinum-sensitive disease that had progressed within six months after first-line treatment with a platinum-based chemotherapy, such as cisplatin or carboplatin. Efficacy endpoints included response rates, progression-free survival, overall survival, improvement in disease-related symptoms and disease control (defined as complete response, partial response and stable disease). The trial was conducted at clinical sites in North America and Eastern Europe.
A total of 77 patients received picoplatin. Median overall survival was 27 weeks following picoplatin administered once every three weeks. Median progression-free survival was 9 weeks. The six-month and one-year survival rates were 51 percent and 17 percent, respectively. The disease control rate was 47 percent in the 77 evaluable patients. The most common side effects observed were hematologic and included thrombocytopenia, neutropenia and anemia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred in the study.
"The publication of these clinical findings in JCO represents an important milestone for Poniard. The positive survival results of the Phase 2 picoplatin trial in this difficult-to-treat disease formed the basis of our decision to initiate the Phase 3 SPEAR trial for which we recently completed patient enrollment ahead of internal projections," said Robert De Jager, M.D., chief medical officer of Poniard. "We are on track to complete the clinical data analysis of the SPEAR trial and initiate the filing of a rolling New Drug Application with the FDA for picoplatin in SCLC this year. If approved, picoplatin could represent an important new treatment for SCLC. In addition, it potentially enables other trials of picoplatin in patients with other solid tumors who relapse or are refractory to first-line platinums, such as in non-small cell lung cancer and ovarian cancer."
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date indicate that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have been treated with 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.
The SPEAR trial is comparing picoplatin plus best supportive care, to best supportive care alone, to evaluate the efficacy and safety of picoplatin after relapse in SCLC patients. The primary efficacy endpoint is overall survival. Progression-free survival, overall response rate, and disease control are also being evaluated. The Company is currently evaluating picoplatin in two Phase 2 clinical trials -- one is evaluating the safety and efficacy of picoplatin in patients with metastatic colorectal cancer and the other 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.
(1) Eckardt JR, Bentsion DL, Lipatov ON, et al. Phase II Study of Picoplatin as Second-Line Therapy for Patients With Small-Cell Lung Cancer. JCO 2009;27:2046-2051.
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