Poniard Announces Positive Efficacy and Safety Data From Phase 1 Trial of Picoplatin in Multiple Tumor Types Including Ovar...(have a poor prognosis.There is a need fo...),Health

Dr. Dizon presented the clinical trial data (abstract #2568) in the General Poster Session during the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) at McCormick Place in Chicago.

"These data provide additional proof-of-concept that picoplatin has the potential to be a platform product with broad clinical utility in multiple tumor types. We believe these data support additional clinical trials with this combination for the treatment of ovarian cancer, including a potential registration trial," said Robert De Jager, M.D., chief medical officer of Poniard. "The clinical activity of picoplatin alone or in combination with liposomal doxorubicin warrants further clinical development in advanced ovarian cancer pretreated with platinum-based chemotherapy. This combination may also enable further testing in other tumor types sensitive to doxorubicin."

Phase 1 Study Design and Results

The Phase 1 trial enrolled 16 patients with advanced solid tumors who had received up to three prior regimens for metastatic disease. Patients were administered picoplatin followed by liposomal doxorubicin on day one of a 28-day cycle. Four dose levels of picoplatin and pegylated liposomal doxorubicin were tested: 100/20, 100/30, 100/40 and 120/40 (all mg/m2). A total of 62 courses of treatment were delivered to 16 patients with a median number of four cycles per patient.

A total of 12 patients were evaluable for response. One patient experienced a complete response (primary peritoneal cancer) and four experienced a partial response (including three of five patients with ovarian cancer). Hematologic and non-hematologic toxicity were mild. This study suggests that picoplatin and liposomal doxorubicin is an active combination with promising results and can be given at standard dose levels with a minimal increase in to
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