SOUTH SAN FRANCISCO, Calif. and CHICAGO, June 1 Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical companyfocused on oncology, today announced safety and efficacy results from apreviously unpublished Phase 1 clinical trial of picoplatin and liposomaldoxorubicin in patients with advanced solid tumors, including ovarian cancer.Results demonstrated signals of clinical activity and acceptable toxicity withthis combination.
Picoplatin, the Company's lead product candidate, is a new generationplatinum chemotherapy agent with the potential to address multipleindications, combinations and formulations. Doxorubicin, the activepharmaceutical ingredient of liposomal doxorubicin, is used in the treatmentof a wide range of tumor types (e.g., breast, ovarian, lung, gastric, liver,bladder, thyroid, lymphomas and leukemias). Liposomal doxorubicin is approvedfor the treatment of patients with ovarian cancer whose disease has progressedor recurred after platinum-based chemotherapy. The standard of care fornon-platinum-based chemotherapy in relapsed ovarian cancer is liposomaldoxorubicin.
"The phase 1 trial in advanced solid tumors showed that both agents couldbe combined with an acceptable toxicity profile," said Don S. Dizon, M.D.,assistant professor of obstetrics-gynecology and medicine at the Warren AlpertMedical School of Brown University. "In addition, the response rates observedwith picoplatin with this new combination, particularly in those women withovarian cancer, are promising and warrant further study. Advanced ovariancancer is among the deadliest cancers, and patients who have failed initialtherapy typically have a poor prognosis. There is a need for treatments thatimprove outcomes achieved with the current standard of care."
Dr. Dizon presented the clinical trial data (abstract #2568) in theGeneral Poster Session during the 44th Annual Meeting of the American Societyof Clinical Oncology (ASCO) at McCormick Place in Chicago.
"These data provide additional proof-of-concept that picoplatin has thepotential to be a platform product with broad clinical utility in multipletumor types. We believe these data support additional clinical trials withthis combination for the treatment of ovarian cancer, including a potentialregistration trial," said Robert De Jager, M.D., chief medical officer ofPoniard. "The clinical activity of picoplatin alone or in combination withliposomal doxorubicin warrants further clinical development in advancedovarian cancer pretreated with platinum-based chemotherapy. This combinationmay also enable further testing in other tumor types sensitive todoxorubicin."
Phase 1 Study Design and Results
The Phase 1 trial enrolled 16 patients with advanced solid tumors who hadreceived up to three prior regimens for metastatic disease. Patients wereadministered picoplatin followed by liposomal doxorubicin on day one of a28-day cycle. Four dose levels of picoplatin and pegylated liposomaldoxorubicin were tested: 100/20, 100/30, 100/40 and 120/40 (all mg/m2). Atotal of 62 courses of treatment were delivered to 16 patients with a mediannumber of four cycles per patient.
A total of 12 patients were evaluable for response. One patientexperienced a complete response (primary peritoneal cancer) and fourexperienced a partial response (including three of five patients with ovariancancer). Hematologic and non-hematologic toxicity were mild. This studysuggests that picoplatin and liposomal doxorubicin is an active combinationwith promising results and can be given at standard dose levels with a minimalincrease in toxicity.
In a previous Phase 2 study of picoplatin monotherapy inplatinum-pretreated ovarian cancer patients, disease control was achieved in57 percent of 82 evaluable patients: 8 patients had a complete response, 7 hada partial response and 32 experienced disease stabilization.