NewsRx.com
June 12, 2008
Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on oncology, today presented preliminary safety and efficacy data from its ongoing Phase 2 clinical trial of picoplatin in combination with docetaxel and prednisone, the standard of care for the first-line treatment of metastatic hormone-refractory prostate cancer (HRPC). Results demonstrated that picoplatin can be safely administered with full doses of docetaxel. In addition, the prostate specific antigen (PSA) response rate was 69 percent in 26 patients evaluable for PSA.
The Company presented the Phase 2 data (abstract #5153) in the General Poster Session during the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) at McCormick Place in Chicago. Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.
"The promising results of this Phase 2 trial in HRPC support further development of picoplatin in the treatment of prostate cancer," said Robert De Jager, M.D., chief medical officer of Poniard. "A prospective randomized trial is under consideration. The combination of picoplatin with a taxane could be further evaluated in other tumor types, such as ovarian cancer and non-small cell lung cancer."
Phase 2 HRPC Study Preliminary Results
In the ongoing Phase 2 trial, the efficacy and safety of intravenous picoplatin (120 mg/m squared) administered every 21 days in combination with full-dose docetaxel (75 mg/m squared) with daily prednisone (5 mg) as a first-line treatment is being evaluated in 30 patients with metastatic HRPC. PSA response (defined as a PSA reduction of at least 50 percent from baseline) is the primary endpoint; secondary endpoints include safety, response rate, time to progression and overall survival. The trial completed enrollment in December 2007.
Results to date have shown a PSA response in 18 of 26 (69 percent) evaluable patients. Furthermore, PSA levels have normalized in six patients (21 percent). The combination of picoplatin and docetaxel can be safely administered with manageable and reversible neutropenia as the main hematologic toxicity. These data confirm earlier results observed in the Phase 1 trial. In contrast to picoplatin monotherapy, thrombocytopenia was less severe and less frequent. Neurotoxicity has not been observed in this study.
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