Poniard Pharmaceuticals Announces Picoplatin Safety Data In Colorectal Cancer
The poster presentation included safety data from a Phase 1 study of picoplatin in combination with 5-fluorouracil (5FU) and leucovorin (LV) as a first-line treatment for metastatic colorectal cancer (mCRC). The Phase 1 study seeks to establish the maximum tolerated dose of picoplatin and provide information on the safety of picoplatin when combined with 5FU and LV for the treatment of colorectal cancer. Promising safety data observed from the study to date formed the basis for further development of picoplatin in our ongoing Phase 2 trial in mCRC.
"These study results suggest that picoplatin does not cause severe neurotoxicity, as is commonly seen in mCRC patients treated with the regimen of 5FU and LV with oxaliplatin," said Jerry McMahon, Ph.D., chairman and CEO of Poniard Pharmaceuticals. "Picoplatin has demonstrated both good tolerability and no severe neuropathies when combined with 5FU and LV. We believe picoplatin has the potential to be a preferred platinum for the treatment of colorectal and other cancer indications."
Current National Comprehensive Cancer Network (NCCN) guidelines encourage the discontinuation of FOLFOX (5FU and LV with oxaliplatin) after three months of therapy or sooner if significant (Grade 3 or greater) neurotoxicity develops. For more information, please see http://www.nccn.org.
In the Phase 1 study, 50 patients were treated with picoplatin on either an every-two-week or an every-four-week basis in combination with the standard of care every-two-week dose of 5FU and LV. Patients received up to 28 cycles, and the therapy was well tolerated. Increased hematological toxicity was observed at higher doses. None of the patients treated with picoplatin exhibited a Grade 3 or higher neuropathy and only 9 of 45 patients (20 percent) experienced mild neuropathy. No neuropathy of Grade 2 or greater was observed in the 26 patients who received greater than or equal to 400 mg/m squared picoplatin. Mild nephro- and oto- toxicity were observed infrequently. The dose limiting toxicity (DLT) was most frequently hematological with neutropenia and thrombocytopenia. The maximum tolerated dose was established in the every-four-week schedule at 150 mg/m squared. The maximum tolerated dose for the every-two-week schedule has not yet been reached.
Based on the evidence of a more attractive safety profile of picoplatin in this combination (FOLPI) compared to the standard of care regimen with oxaliplatin (FOLFOX) as well as clinical activity in the Phase 1 study, the Company initiated a randomized Phase 2 trial in November, 2007 to evaluate intravenous picoplatin in the first-line treatment of mCRC. The Phase 2 trial is intended to generate proof-of-concept data to further evaluate efficacy and safety, including neuropathy of picoplatin in combination with 5-FU and LV (FOLPI versus FOLFOX) and to provide support for a potential registrational Phase 3 trial. The Company expects to present data from the Phase 1 and 2 mCRC program in scientific forums around mid year.
About Picoplatin
Picoplatin is an intravenous 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 demonstrated activity in multiple indications with no evidence of significant kidney, nerve toxicity or hearing loss, toxicities commonly observed with other platinum chemotherapy drugs.
In addition to the Phase 2 clinical trial in patients with mCRC, 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 is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and is evaluating overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial for the treatment of hormone refractory prostate cancer (HRPC). 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. Picoplatin, the Company's lead platform product candidate, is a new generation platinum therapy with an improved safety profile. Picoplatin is designed to overcome and prevent 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 cancer, as well as a clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by regulatory authority for use in humans. For additional information please visit http://www.poniard.com.
This release contains forward-looking statements, including statements regarding the Company's business objectives and strategic goals, 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, including the Company's Annual Report on Form 10-K for the year ended December 31, 2006, as amended, and most current Quarterly Report on Form 10-Q. 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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