EWING, N.J., June 6, 2016 /PRNewswire/ -- Celator
Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced results from
its Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome
for Injection (also known as CPX-351) in patients with high-risk
(secondary) acute myeloid leukemia (AML) were presented at the
American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.
As previously reported, the trial met its primary endpoint
demonstrating a statistically significant improvement in overall
survival. The Phase 3 trial compared to the standard of care
regimen of cytarabine and daunorubicin known as 7+3.
The median overall survival for patients treated with VYXEOS in
the study was 9.56 months compared to 5.95 months for patients
receiving 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.
Event-free survival was also statistically significant in favor
of VYXEOS. The HR was 0.74 (p-value=0.021). The median event-free
survival was 2.53 months in the VYXEOS arm compared to 1.31 months
in the 7+3 arm.
"We believe the promising primary efficacy results of CPX-351 in
high risk AML, across multiple parameters, support its use as the
new standard of care in a difficult-to-treat population," said
Jeffrey E. Lancet, M.D., senior member and chief of the
Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the
principal investigator for the study. "This is an important step
forward in the treatment of a terrible disease, and hopefully this
platform for synergistic drug delivery will continue to advance the
field."
VYXEOS also demonstrated a statistically significant improvement
in induction response rate (CR+CRi of 47.7% versus 33.3%; p=0.016)
and this significance was maintained for the analysis of CR alone
(CR of 37.3% versus 25.6%, p=0.040).
Thirty-four percent of VYXEOS treated patients received a stem
cell transplant (SCT) compared to 25% of 7+3 treated patients. In a
landmark survival analysis of patients receiving a SCT, VYXEOS
patients had significantly improved survival post-transplant (HR
was 0.46 (p-value=0.0046)). The median overall survival had not
been reached in the VYXEOS treated patients compared to 10.25
months in the 7+3 treated patients.
Thirty-day and sixty-day all-cause mortality favored VYXEOS.
Thirty-day mortality was 5.9% compared to 10.6% and sixty-day
mortality was 13.7% versus 21.2%.
Grade 3-5 non-hematologic and hematologic adverse events were
similar between the VYXEOS and 7+3 arms.
The company expects to submit a New Drug Application (NDA) for
VYXEOS with the U.S. Food and Drug Administration (FDA) by the end
of the third quarter of 2016 and submit a Marketing Authorization
Application (MAA) with the European Medicines Agency (EMA) in the
first quarter of 2017.
"We are very pleased to have this opportunity to share the data
from our Phase 3 trial with the oncology community. This successful
outcome represents an important advance for AML patients, their
families and clinicians," said Scott
Jackson, Chief Executive Officer of Celator Pharmaceuticals.
"We thank the patients and investigators who participated in this
study and we will work closely with regulatory authorities to make
this new treatment available to the AML community as soon as
possible."
The clinical trial was conducted in partnership with The
Leukemia & Lymphoma Society® (LLS) through its Therapy
Acceleration Program (TAP), which has supported the clinical
development of VYXEOS beginning in Phase 2.
Phase 3 Trial Design
The randomized, controlled, Phase 3 trial (Protocol
NCT01696084), enrolled 309 patients at 39 sites in the United States and Canada, and compared VYXEOS to the
conventional cytarabine and daunorubicin treatment regimen
(commonly referred to as 7+3) as first-line therapy in older (60-75
years of age) patients with high-risk (secondary) AML. Patients
were stratified for age (60 to 69 and 70 to 75 years of age) and
AML type; treatment-related AML, AML with documented history of
myelodysplastic syndrome (MDS) with prior treatment with
hypomethylating agent therapy, AML with documented history of MDS
without prior hypomethlyating agent therapy, AML with a documented
history of chronic myelomonocytic leukemia (CMMoL), and de novo AML
with a karyotype characteristic of MDS.
Patients were randomized 1:1 to receive either VYXEOS or 7+3.
Patients could receive one or two inductions, and responding
patients could receive one or two consolidations. First induction
for VYXEOS was 100u/m2; days 1, 3, and 5 by 90-minute
infusion and for the control arm was cytarabine
100mg/m2/day by continuous infusion for 7 days and
daunorubicin 60mg/m2 on days 1, 2, and 3 (7+3). Second
induction for VYXEOS-treated patients was 100u/m2 on
days 1 and 3, and the control arm was cytarabine
100mg/m2/day by continuous infusion for 5 days and
daunorubicin 60mg/m2 on days 1 and 2 (5+2).
Only patients with documented CR or CRi were eligible to receive
chemotherapy consolidation. Consolidation for VYXEOS-treated
patients was 65u/m2 on days 1 and 3 and the control arm
was cytarabine 100mg/m2/day by continuous infusion for 5
days and daunorubicin 60mg/m2 on days 1 and 2 (5+2).
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.
About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of
the blood characterized by the uncontrolled proliferation of
immature blast cells in the bone marrow. AML is generally a
disease of older adults, and the median age of a patient diagnosed
with AML is about 67 years. The American Cancer Society estimates
that there will be 19,950 new cases of AML and 10,430 deaths from
AML in the U.S. in 2016. In Europe
the number of new cases is estimated to be 18,000 and in
Japan the number is 5,500. The
Company estimates that nearly 70 percent of AML patients are over
the age of 60, and approximately 75% are intermediate or high risk.
Furthermore, approximately half of those patients are considered
suitable for intensive treatment.
Even with current treatment, overall survival for AML is poor.
In patients over 60 years of age, the 5 year survival rate is less
than 10%. In high-risk (secondary) AML, overall survival is lower,
resulting in an acute need for new treatment options for these
patients.
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.
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,
therapeutic potential and commercial potential of VYXEOS™ (also
known as CPX-351), our expectations regarding the timing of our
regulatory filings, 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. 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 10-Q and 8-K, and other
filings by the company with the U.S. Securities and Exchange
Commission.
Contacts:
Media:
Sam Brown, Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com
Investors:
The Trout Group
Peter Rahmer, 646-378-2973
prahmer@troutgroup.com
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SOURCE Celator Pharmaceuticals, Inc.