On May 19, 2016 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported 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 (Press release, Celator Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512619]).

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Presentation at ASCO (Free ASCO Whitepaper) 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 (Free EHA Whitepaper) 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 (Free ASCO Whitepaper) abstracts became available at 5:00pm ET on May 18th (abstracts.asco.org) and the EHA (Free EHA Whitepaper) abstracts at 12:00pm CET on May 19th (EHA Learning Center – Official eLearning Portal of the European Hematology Association (EHA) (Free EHA Whitepaper)).

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 protected]), regarding attendance. The meeting will be webcast and available on Celator’s website (www.celatorpharma.com).

About VYXEOS

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