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. (Nasdaq: 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 AML cells harboring the FLT3-ITD mutant phenotype opens exciting opportunities to test VYXEOS in this AML patient population.  We will submit data from patients exhibiting this mutation, who were treated in the recently completed Phase 3 trial, to an upcoming medical conference."

The poster will be available on Celator's website (www.celatorpharma.com) at the conclusion of the AACR meeting.

About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator's proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor. Celator's lead product is VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin in Phase 3 clinical testing for the treatment of acute myeloid leukemia. We have also conducted clinical development on CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer and have a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation. More recently, the company has advanced its CombiPlex platform and broadened its application to include molecularly targeted therapies. For more information, please visit Celator's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.

Forward-Looking Statements:
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the safety, potential efficacy and therapeutic potential of VYXEOS™ (also known as CPX-351), our expectations regarding the timing of our regulatory filings, our expectations regarding our research and development programs and advancing our CombiPlex platform and the potential to establish research and development collaborations applying our proprietary technologies with other biotechnology/pharmaceutical companies. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our development programs, future results, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of clinical studies, whether clinical study results obtained to date will be predictive of future results, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates. Celator undertakes no obligation to update or revise any forward-looking statements. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Celator's Form 10-K for the year ended December 31, 2015, subsequent reports on Form 8-K, and other filings by the company with the U.S. Securities and Exchange Commission.

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SOURCE Celator Pharmaceuticals, Inc.