VYXEOS Phase 3 data to be presented at ASCO on June 4th Additional data from the Phase 3 trial, including data demonstrating benefit in AML patients with FLT3 mutations to be presented at EHA on June 11th
Company to Host Analyst and Investor Meeting on VYXEOS in Chicago on June 4th
EWING, N.J., May 19, 2016 /PRNewswire/ — Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) today announced that Phase 3 clinical trial data for VYXEOS™ (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, will be presented at upcoming medical conferences.
Presentation at ASCO Annual Meeting in Chicago, June 3-7, 2016:
Date & Track Time: Saturday, June 4, 2016 – 3:00pm to 6:00pm CT
Track: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presentation Title: Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML
Presenter: Jeffrey E. Lancet, M.D., H. Lee Moffitt Cancer Center & Research Institute
Abstract #: 7000
Presentation Time: 3:00pm to 3:12pm CT
Location: Arie Crown Theatre
Presentation at EHA Annual Congress in Copenhagen, June 9-12, 2016:
Date: Saturday, June 11, 2016
Topic: Acute Myeloid Leukemia – Clinical Session
Title: New Compounds in AML Treatment
Presentation Title: CPX-351 treatment of previously untreated older AML patients with high-risk AML markedly increases the response rate over 7+3 in patients with FLT3 mutations
Presenter: Bruno C. Medeiros, M.D., Stanford University
Abstract Code: S502
Presentation Time: 4:15pm to 4:30pm CET
Location: Hall A3
The ASCO abstracts became available at 5:00pm ET on May 18th (abstracts.asco.org) and the EHA abstracts at 12:00pm CET on May 19th (EHA Learning Center – Official eLearning Portal of the European Hematology Association (EHA)).
Analyst and Investor Meeting on VYXEOS
Celator will host an Analyst and Investor meeting on Saturday, June 4, 2016 at the Chicago Marriott Downtown Magnificent Mile starting at 7:00pm CT. The meeting will discuss data from the Phase 3 clinical trial in high-risk AML patients. Seating is limited, please contact the Trout Group, Brooks Rahmer (email@example.com), regarding attendance. The meeting will be webcast and available on Celator’s website (www.celatorpharma.com).
VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC. VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission. VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.
In a Phase 3 trial in patients with high-risk (secondary) AML, the median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3, representing a 3.61-month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.
Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS. No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.
Celator published results from two randomized, controlled, Phase 2 trials with VYXEOS. The first trial was conducted in newly diagnosed elderly AML patients and the second trial was conducted in patients with AML in first relapse.
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 that has completed a Phase 3 trial for the treatment of acute myeloid leukemia. Celator has 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.
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 the
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.
Sam Brown, Inc.
Mike Beyer, 312-961-2502
The Trout Group
Peter Rahmer, 646-378-2973
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