Results from ongoing Phase I study of advanced leukemia and myelodysplastic syndrome patients presented at American Society for Hematology meeting.
PRINCETON, N.J., Dec. 10 /PRNewswire/ -- Celator Pharmaceuticals today announced results from an ongoing Phase I study of CPX-351, a liposomal formulation that incorporates a synergistic ratio of cytarabine and daunorubicin for the treatment of advanced leukemias and myelodysplastic syndromes. While dose escalation in the study is ongoing, thus far three patients treated with CPX-351 have achieved complete remissions (CR), one patient has achieved a CRp (complete remission where platelets did not recover to greater than 100,000 platelets per microliter), and two additional patients achieved partial remissions (PR).
The study included patients with relapsed/refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). All but three of the 27 patients had AML. The majority of patients were older than 60 years of age, including four patients older than 75. All patients had relapsed or refractory disease, with 15/27 having received two or more prior induction therapies. After their last therapy, 19/27 had no response and 8/27 achieved a CR. CPX-351 has been safely administered up to and including 101 units/m2 (=101 mg/m2 of cytarabine and 44mg/m2 of daunorubicin). Non-hematologic adverse events included stomatitis (10/27 patients), skin rash (10/27), diarrhea (9/27), nausea (7/27), vomiting (5/27) and alopecia (2/27). The study has shown that CPX-351 is capable of inducing marrow aplasia with few severe non-hematologic adverse events.
"CPX-351 is a provocative new treatment approach for patients with AML," said Eric Feldman, MD, from Weill Medical College of Cornell University and New York Presbyterian Hospital and an investigator in the Phase I study. "The data from the Phase I study in highly refractory AML patients are encouraging, including both complete remissions and the fact that the drug has been very well-tolerated."
CPX-351 is a liposomal formulation of cytarabine and daunorubicin delivered in a 5:1 molar ratio shown in preclinical studies to represent a synergistic ratio for use in combination chemotherapy. CPX-351 represents a new approach to developing drug combinations in which drug ratios are pre-selected based on synergistic anti-tumor activity observed preclinically and where the ratios are maintained in patients through Celator's proprietary CombiPlex(TM) technology platform.
"According to the study results, CPX-351 maintained the synergistic ratio of cytarabine and daunorubicin in patients. In addition, evidence of clinical benefit seen in this Phase I study is very encouraging and provides substantial additional support to continue to advance CPX-351 in clinical development," said Andrew Janoff, Ph.D., CEO of Celator.
Celator Pharmaceuticals, Inc. is a privately held biopharmaceutical company working to develop new and more effective therapies to treat cancer. CombiPlex, the company's drug ratio technology platform, represents a revolutionary new approach to the development of combination therapies based on the optimal ratio of drug agents to target cancer cells effectively. The company pipeline includes: CPX-1, currently in a Phase II trial as a treatment option for colorectal cancer; CPX-351, currently in a Phase I trial as a treatment for leukemia (for information visit http://www.clinicaltrials.gov and search "Celator"); CPX-571, now positioned to advance to Phase I trial and targeting small cell lung cancer; and multiple early stage pre-clinical development programs. Based on the applications of CombiPlex, Celator is positioned to advance a broad pipeline of combination therapies involving both previously approved and novel drug agents.
|SOURCE Celator Pharmaceuticals|
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