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Celator® Pharmaceuticals Announces Positive Data for VYXEOS™ in FLT3-ITD Mutated Acute Myeloid Leukemia (AML) Cells Derived from Patients with Newly Diagnosed AML

EWING, N.J., April 18, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (CPXX) today announced that positive data for VYXEOS™ (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, were presented at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA, April 16-20, 2016.

The presentation, titled "CPX-351 cytotoxicity against fresh AML blasts is increased for FLT3-ITD+ cells and correlates with drug uptake and clinical outcomes," was based on research conducted in the laboratory of Jeffrey Tyner, Ph.D. at Oregon Health & Science University and examined the ex vivo sensitivity of AML cells derived from newly diagnosed patients to VYXEOS.

The profile of ex vivo AML blast sensitivity to VYXEOS mirrors the efficacy profile observed clinically and may provide a means to identify specific AML patient genotypes/phenotypes that could benefit most from VYXEOS treatment. The increased sensitivity of FLT3-ITD+ (internal tandem duplication) blasts to VYXEOS is an example of how such analyses may identify additional AML patient populations warranting further clinical investigation.

FLT3-ITD mutant expression has historically been a predictor of poor patient outcomes to conventional treatment regimens. A notable result from this research was the observation that AML cells exhibiting the FLT3-ITD mutation were approximately five times more sensitive to VYXEOS than AML cells with normal FLT3. In addition, there was evidence that increased sensitivity to VYXEOS is associated with increased uptake of the drug-laden liposomes by leukemia cells.

"Testing cell killing activity against fresh AML cells outside the body allows us to identify specific AML cell-VYXEOS interactions that could be exploited clinically," said Dr. Tyner. "We are particularly excited about the marked increase in sensitivity of FLT3-ITD cells to VYXEOS and are working to better understand the mechanism underlying this phenomenon."

"VYXEOS continues to deliver positive efficacy read-outs," said Lawrence Mayer, Ph.D., President and Chief Scientific Officer at Celator. "The encouraging activity of VYXEOS against...


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