Celator Pharmaceuticals Announces Positive Data From Phase 2 Study of CPX-351 in Acute Myeloid Leukemia
PRINCETON, N.J., May 3 /PRNewswire/ -- Celator Pharmaceuticals,
Inc. today announced positive results from its Phase 2 study of
CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus
conventional cytarabine and daunorubicin (the "7+3" regimen) in
patients, 60-75 years of age, with untreated acute myeloid leukemia
(AML). The primary endpoint of the study, the rate of patients
achieving a complete remission with CPX-351 compared to "7+3,"
achieved statistical significance. In addition, there was a
reduction in the 30-day and 60-day mortality with CPX-351 versus
the "7+3" regimen.
The multicenter, randomized, open-label trial enrolled a total
of 126 patients between November 2008 and October 2009. Patient
follow-up is ongoing. Results from this study will be submitted to
a major medical conference in 2010.
"The control arm, cytarabine plus daunorubicin, has been the
standard of care for treating patients with AML for more than 30
years," said Arthur Louie, MD, chief medical officer at Celator
Pharmaceuticals, Inc. "To demonstrate an improvement in complete
remission rate coupled with an improvement in early death rate is
very encouraging. We expect to have additional information on the
secondary endpoints later this year."
The primary endpoint of the study was a comparison of complete
remission rates - which includes complete remissions (CR) and
complete remissions with an incomplete recovery, to a specified
level, of neutrophils and/or platelets (CRi). Both CR and CRi
result in patients becoming leukemia-free. The secondary endpoints
of the study include duration of complete remission, event-free
survival, 12-month survival, and the rate of patients going on to
receive stem cell transplantation. The full safety analysis will
include 30-, 60-, and 90-day mortality rates.
"We are very excited that CPX-351 may offer patients a new, more
effective treatment option," said Scott Jackson, chief executive
officer at Celator Pharmaceuticals, Inc. "These data suggest that
our approach with CPX-351 significantly improves clinical benefit
compared to conventional administration of cytarabine and
daunorubicin. We will meet with the FDA later this year to discuss
our results and plans for a Phase 3 study of CPX-351 in AML."
CPX-351 (Cytarabine:Daunorubicin) Liposome Injection represents
a new approach to developing combinations of drugs in which drug
molar ratios with synergistic anti-tumor activity are encapsulated
in a drug delivery vehicle in order to maintain the desired ratio
following administration. CPX-351 has been granted orphan drug
status by the U.S. Food & Drug Administration (FDA) for the
treatment of AML. Celator is currently conducting a second
randomized phase 2 study of CPX-351 versus intensive salvage
therapy in patients up to 65 years of age with AML in first
relapse. Enrollment is expected to be completed in 2010. This study
is supported by The Leukemia & Lymphoma Society.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ,
and Vancouver, BC, is a privately held pharmaceutical company
developing new and more effective therapies to treat cancer.
CombiPlex®, 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 phase 2 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; a
preclinical stage compound, CPX-571 (a liposomal formulation of
irinotecan:cisplatin); and multiple research programs, including
the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation
being studied by the National Cancer Institute's Nanotechnology
Characterization Laboratory. Based on the applications of CombiPlex
and the proprietary nanoparticle prodrug delivery platform, Celator
is positioned to advance a broad pipeline of cancer therapies
involving both previously approved and novel drug agents. For more
information, please visit the company's website at
www.celatorpharma.com. Information on ongoing trials is available
Source: Celator Pharmaceuticals, Inc.
CONTACT: Mike Beyer, +1-773-463-4211, firstname.lastname@example.org
Web Site: http://www.celatorpharma.com/
Posted: May 2010