CELATOR(R) PHARMACEUTICALS REACHES 50% ENROLLMENT FOR CPX-351 PHASE 3 STUDY
EWING, N.J., Jan. 9, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc.
(CLPM), a pharmaceutical company developing new and more effective therapies
to treat cancer, today announced that the Company's Phase 3 clinical
study comparing CPX-351 (cytarabine:daunorubicin) Liposome Injection versus
the conventional cytarabine and daunorubicin treatment regimen (commonly
referred to as 7+3) as first-line therapy in older patients with high-risk
(secondary) acute myeloid leukemia (AML) has reached 50% of the study's
planned enrollment of 300 patients.
"We are excited to announce that the Phase 3 study is enrolling slightly ahead
of schedule, and we expect enrollment will be completed in the fourth quarter
of this year," said Scott Jackson, Celator's Chief Executive Officer. "We are
hopeful this study will confirm the findings seen in patients with secondary
AML in a Phase 2 study, as these patients are in great need of better
The Phase 3 study is being conducted in partnership with The Leukemia &
Lymphoma Society® (LLS) through its Therapy Acceleration Program (TAP), which
has supported the development of CPX-351 beginning in Phase 2.
The study (Protocol NCT01696084) is currently enrolling patients between the
ages of 60 and 75 who have pathological diagnosis of AML according to WHO
criteria (with at least 20% blasts in the peripheral blood or bone marrow)
with confirmation of one of the following:
* Therapy-related AML
* AML with a history of myelodysplasia (MDS)
* AML with a history of chronic myelomonocytic leukemia (CMMoL)
* De novo AML with karyotypic abnormalities characteristic of MDS
Patients are randomized 1:1 to receive either CPX-351 (100 u/m^2; Days 1, 3,
and 5 by 90 minute infusion) or 7+3 (cytarabine 100 mg/m^2/day by continuous
infusion for 7 days and daunorubicin 60 mg/m^2 on days 1, 2, and 3). The
primary efficacy endpoint of the study is overall survival. The study is being
conducted in the United States and Canada with approximately 40 leading cancer
Patient enrollment is expected to complete in the fourth quarter of 2014.
Initial data from the study, on secondary endpoints such as remission rate
and selected safety data, could be available in the second quarter of 2015.
The primary endpoint, overall survival, is projected to be available in the
first quarter 2016.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex(R), the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two clinical stage products, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; and preclinical stage product candidates, including CPX-571 (a liposomal formulation of irinotecan:floxuridine), and hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. For more information, please visit the company'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. 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, our expectations regarding our development plans for and the potential efficacy, therapeutic potential of our drug candidates, our expectations regarding the trading of our common stock and other matters that could affect the availability or 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, 2012 and other filings by the company with the U.S. Securities and Exchange Commission.
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