Celator Pharmaceuticals, Inc., a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that patients have been enrolled in an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection as a treatment for patients with higher risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), who are refractory to or in relapse after hypomethylating agent (HMA) therapy.
"Disease progression after hypomethylating agent treatment in patients with MDS and AML signals poor prognosis. As a consequence, Celator is extending the use of CPX-351 as a potential treatment for patients no longer responsive to HMA therapy in a clinical trial that will be led by investigator Bruno C. Medeiros at the Stanford University School of Medicine," said Arthur C. Louie, Chief Medical Officer of Celator Pharmaceuticals. "We are delighted to support proposals from investigators for studying indications beyond secondary AML."
The Phase 2 study is expected to enroll up to 33 patients, with the primary objective being to determine the efficacy and safety profile of CPX-351 in patients 60 years of age and older with higher risk MDS or AML. Patients must have progressed after prior HMA therapy. This includes patients older than 75 years of age with higher risk MDS who are HMA relapsed/refractory who have progressed to AML, as well as AML patients with relapsed/refractory disease after prior HMA therapy for AML. Patients will receive a first induction of CPX-351 on days 1, 3, and 5 and, if a morphological leukemia-free state is not achieved, they will receive a second course of induction therapy. After one or two inductions, patients achieving complete remission (with or without blood count recovery) will receive consolidation therapy with CPX-351 on days 1 and 3.
Secondary endpoints include the duration of remission, overall survival at 12 months and early mortality within 60 days of first induction.
"We continue to be excited by the interest from investigators in evaluating CPX-351 in broader patient populations," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "We believe there is significant potential for CPX-351 as a treatment for other hematologic malignancies beyond secondary AML, the indication being studied in the ongoing Phase 3 study, and remain committed to exp