Celator® Pharmaceuticals Announces Positive Data Showing VYXEOS™ Benefit in Patients with AML

Celator Pharmaceuticals, Inc.

today announced positive data for VYXEOS™ (also known as CPX-351) were presented in two presentations at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, December 5-8, 2015. Abstract Title: CPX-351 ((Cytarabine:Daunorubicin) Liposome Injection, (Vyxeos)) Does Not Prolong QTcF Intervals, Requires No Dose Adjustment for Impaired Renal Function and Induces High Rates of Complete Remission in Acute Myeloid Leukemia This Phase 2 study was undertaken to support potential marketing applications for VYXEOS worldwide. Twenty-six patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) were enrolled. The study showed VYXEOS did not prolong the QT/QTc interval, a positive safety outcome. The drugs remain encapsulated in the nano-scale delivery vehicle while circulating in the plasma (>97% over the first 24 hours), which allows the drugs to be delivered directly to leukemia cells at the synergistic 5:1 molar ratio. The study included patients with newly diagnosed AML, relapsed/refractory AML and relapsed/refractory ALL. Thirteen of the 26 patients responded. Responses were seen in each of the three acute leukemia patient populations. Responders / # of Patients Response Rate Newly diagnosed AML 8 / 13 61.5% Relapsed/Refractory AML 4 / 11 36.4% Relapsed/Refractory ALL 1 / 2 50.0% In addition, the study showed that no dose adjustment is required in patients with renal impairment. Adverse events were similar in frequency and severity to those described in earlier studies. "We are encouraged to report that CPX-351 did not prolong cardiac repolarization, and the pharmacokinetic results indicate that no dose modification is necessary in patients with renal impairment," said Tara Lin, M.D., Assistant Professor of Medicine at The University of Kansas Cancer Center, the lead investigator of this study. "Also, we are happy to report that this study confirms the broad activity of CPX-351 in multiple populations of acute leukemia patients." Abstract Title: CPX-351 Enables Administration of Consolidation Treatment in the Outpatient Setting and Increases the Time Spent out of the Hospital after Completion of AML Treatment Compared with 7+3 Health resource utilization (HRU) was assessed using data from a previously published randomized Phase 2 study comparing first-line treatment with VYXEOS vs. the current standard of care, known as the 7+3 regimen, in newly diagnosed older patients (age 60-75) with AML (Lancet, et al. Blood 2014;123(21):3239-3246). Treatment arms were compared for number of hospitalizations, total hospital days, patients responding following a single induction, responding patients receiving consolidation therapy in the outpatient setting, event-free survival (EFS), and the ratio of EFS per inpatient days. Phase 2 study data indicate HRU outcomes are favorable for VYXEOS compared to 7+3. VYXEOS-treated patients required fewer inductions to respond and were more likely to be given consolidation treatment in an outpatient setting (47% vs. 19%). VYXEOS treatment was associated with a substantial increase in EFS days (median: 197 days vs. 60 days), with a slight increase in hospital days (median: 38 days vs. 35 days) resulting in a substantial improvement in the ratio of median EFS days to median hospital days (5.2 vs. 1.7) in favor of VYXEOS. "The improvement in clinical benefit was associated with favorable health resource utilization outcomes, which is an important feature of CPX-351," said Jeffrey Lancet, M.D., Senior Member and Chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and lead investigator on the study. "We look forward to confirmation of this observation from the pivotal trial, expected in the first quarter of 2016." The posters are available on Celator's website (www.celatorpharma.com).