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

- Induced high rates of response with no prolongation of cardiac interval -

- No dose adjustment needed in renal impaired patients -

- Prolonged event-free survival with marked increase in time spent out of the hospital -

Dec 08, 2015, 07:00 ET from Celator Pharmaceuticals, Inc.

EWING, N.J., Dec. 8, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) 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).

About Celator Pharmaceuticals, Inc.

Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a clinical stage 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 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 ensure its exposure to the tumor.  Celator's pipeline includes lead product, VYXEOS™ (also known as CPX-351), a liposomal formulation of cytarabine:daunorubicin being studied for the treatment of acute myeloid leukemia; CPX-1, a liposomal formulation of irinotecan:floxuridine being studied for the treatment of colorectal cancer; and a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation, being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory.  The company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies.  The company is seeking research and development collaborations, applying its proprietary technologies, with other biotechnology/pharmaceutical companies.

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 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, 2014, subsequent reports on Form 10-Q and 8-K, and other filings by the company with the U.S. Securities and Exchange Commission.

CONTACTS:

Media: Mike Beyer Sam Brown, Inc. 312-961-2502 mikebeyer@sambrown.com

Investors: Adam Krop The Trout Group 646-378-2963 akrop@troutgroup.com 

 

SOURCE Celator Pharmaceuticals, Inc.



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