EWING, N.J., Oct. 21, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of VYXEOS™ (CPX-351) on cardiac depolarization/repolarization has concluded and VYXEOS did not prolong the QT/QTc interval.
This study, in adult patients with acute hematologic malignancies, was conducted to support the U.S. Food and Drug Administration (FDA) requirements of a New Drug Application (NDA), which Celator hopes to file for VYXEOS after completing the ongoing Phase 3 clinical study in patients with high risk (secondary) acute myeloid leukemia (AML).
The QT interval represents the amount of time the heart's electrical system takes to depolarize and repolarize during each heartbeat. Prolongation of the QT interval may increase the risk of cardiac arrhythmias and is a biomarker for Torsade de Pointes, a sometimes fatal form of ventricular tachycardia. An intensive QT study is a specialized clinical trial conducted in a relevant patient population designed to assess whether an investigational medication has the potential to prolong the QT interval.
This open-label, single arm, Phase 2 study measured the effects of VYXEOS on cardiac repolarization during the first induction cycle and correlated electrophysiologic changes, as measured by the QT/QTc interval, with a detailed pharmacokinetic assessment of cytarabine and daunorubicin and their metabolites using exposure response modeling methodology. The study completed enrollment in June 2015. Each patient received a first induction of VYXEOS on days 1, 3 and 5 and, if necessary, a second induction for patients with reduced leukemia burden not yet achieving a disease-free state. Responding patients were eligible for up to four consolidation courses.
Patients with newly diagnosed de novo and newly diagnosed secondary AML, relapsed/refractory AML, and relapsed/refractory acute lymphoblastic leukemia (ALL) were enrolled. Responses were seen in patients with de novo AML, newly diagnosed secondary AML, relapsed AML, and refractory ALL. Adverse events were consistent with those previously reported.
Data from this study has been accepted for poster presentation at the 57th American Society of Hematology (ASH) Annual Meeting. The abstract, titled "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," will be presented on Sunday, December 6, 2015 from 6:00 p.m. to 8:00 p.m. EST.
"We continue to work expeditiously to bring VYXEOS before the FDA as a potential new treatment option for patients with acute hematologic malignancies," said Scott Jackson, Chief Executive Officer of Celator. "Clinical pharmacology studies are required by the FDA for new drugs in development, so we are pleased to announce this top-line result and expect to report additional information from this study at the ASH Annual Meeting."
About VYXEOS™ (CPX-351)
Celator's Phase 3 study comparing VYXEOS to the current standard of care, known as 7+3, is being conducted in patients with high-risk (secondary) AML. The Phase 3 study completed enrollment in November 2014. Initial data, from a secondary endpoint, showed an improvement in induction response rate in favor of VYXEOS over the 7+3 control arm: 47.7% versus 33.3% respectively, for a 43.2% relative improvement. The study's primary endpoint, overall survival, is expected in the first quarter of 2016 along with important safety information.
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™ (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.
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™ (CPX-351), the availability of data from clinical studies, and our expectations regarding our research and development programs. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance 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 CPX-351, availability of data from ongoing clinical studies 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. 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 and other filings by the company with the U.S. Securities and Exchange Commission.
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