Healthcare Industry News:  VYXEOS 

Biopharmaceuticals Oncology

 News Release - April 25, 2016

Celator(R) Pharmaceuticals Announces Positive Results Demonstrating Reduced Healthcare Resource Use with VYXEOS(TM) Compared to Standard Treatment for Acute Myeloid Leukemia (AML)

Phase 2 study results presented at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting

EWING, N.J., April 25, 2016 -- (Healthcare Sales & Marketing Network) -- Celator Pharmaceuticals, Inc. (CPXX) today announced that patients treated in a Phase 2 clinical study with VYXEOS™ (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351) with newly diagnosed AML demonstrated reduced healthcare resource use compared to conventional chemotherapy known as 7+3. These results were presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting in San Francisco, CA, April 19-22, 2016.

The presentation, titled "VYXEOS™ (CPX-351) increases event-free survival and time spent out of the hospital in acute myeloid leukemia patients, compared with 7+3 standard of care," was based on data from a clinical study directed by Jeffrey E. Lancet, M.D., senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center. Researchers evaluated treatment details and healthcare resource use in the context of clinical outcomes, such as treatment response and event-free survival (EFS).

VYXEOS treated patients had;
  • a longer EFS, with a median of 197 days compared to 60 days with 7+3,
  • a slightly longer time in the hospital, median of 38 days compared to 35 days. The majority of patients on the VYEXOS arm with hospital stays >60 days also experienced a response (75%) with many having one or more risk factors,
  • a higher ratio of median EFS days to median hospital days, with a ratio of 5.2 compared to 1.7, which means the time spent out of the hospital was longer for the patients treated with VYXEOS,
  • fewer hospital admissions, median of 1 admission with VYXEOS compared to 2 admissions with 7+3,
  • a higher rate of remission after one induction cycle (42/56 vs. 15/21; p=0.03), and
  • received consolidation treatment more frequently as outpatients (15/37 vs. 2/15; p=0.02).
High risk, including secondary, AML patients treated with VYXEOS also had longer EFS and a favorable ratio of EFS days to hospital days.

"This is the first time we have evaluated the impact of VYXEOS on hospital resource use in relation to its established clinical benefit," said Dr. Lancet. "Although, we did see longer hospital stays in VYXEOS treated patients, some of those costs are clearly offset by fewer hospital admissions and outpatient consolidation treatments in this group. This study suggests significant value that VYXEOS could provide for patients, providers and payers over the course of the disease."

The poster will be 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 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. The Company 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.

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, 2015, subsequent reports on Form 8-K, and other filings by the company with the U.S. Securities and Exchange Commission.


Source: Celator Pharmaceuticals

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