NewsRx.com
June 12, 2008
Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on oncology, announced safety and efficacy results from a previously unpublished Phase 1 clinical trial of picoplatin and liposomal doxorubicin in patients with advanced solid tumors, including ovarian cancer. Results demonstrated signals of clinical activity and acceptable toxicity with this combination.
Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to address multiple indications, combinations and formulations. Doxorubicin, the active pharmaceutical ingredient of liposomal doxorubicin, is used in the treatment of a wide range of tumor types (e.g., breast, ovarian, lung, gastric, liver, bladder, thyroid, lymphomas and leukemias). Liposomal doxorubicin is approved for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. The standard of care for non-platinum-based chemotherapy in relapsed ovarian cancer is liposomal doxorubicin.
"The phase 1 trial in advanced solid tumors showed that both agents could be combined with an acceptable toxicity profile," said Don S. Dizon, M.D., assistant professor of obstetrics-gynecology and medicine at the Warren Alpert Medical School of Brown University. "In addition, the response rates observed with picoplatin with this new combination, particularly in those women with ovarian cancer, are promising and warrant further study. Advanced ovarian cancer is among the deadliest cancers, and patients who have failed initial therapy typically have a poor prognosis. There is a need for treatments that improve outcomes achieved with the current standard of care."
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 toxicity.
In a previous Phase 2 study of picoplatin monotherapy in platinum-pretreated ovarian cancer patients, disease control was achieved in 57 percent of 82 evaluable patients: 8 patients had a complete response, 7 had a partial response and 32 experienced disease stabilization.
Copyright 2008, Hematology Week via NewsRx.com
