Celator(R) Pharmaceuticals Completes Enrollment Early in Phase 2 Study of CPX-351 in Newly Diagnosed AML
* Reuters is not responsible for the content in this press release.
Celator(R) Pharmaceuticals Completes Enrollment Early in Phase 2 Study of
CPX-351 in Newly Diagnosed AML
--Interim Results to be Presented at the 2009 American Society of Hematology
(ASH) Annual Meeting--
PRINCETON, N.J., Oct. 12 /PRNewswire/ -- Celator Pharmaceuticals today
announced that it has completed enrollment in its Phase 2 multicenter,
randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin)
Liposome Injection versus conventional cytarabine and daunorubicin therapy
("7+3") in patients 60-75 years of age with untreated acute myeloid leukemia
(AML). The target enrollment of 120 patients was reached in less than 11
months, nearly 3 months faster than anticipated.
"We are grateful to the patients who have entered this study and to the
investigators and their teams whose enthusiasm and commitment made it possible
to complete enrollment ahead of schedule," said Scott Jackson, chief executive
officer of Celator Pharmaceuticals. "We look forward to presenting our first
look at the data - what we hope will be additional evidence of the benefits of
CPX-351 in this patient population - later this year at the American Society
of Hematology."
The Phase 2 study enrolled patients with newly diagnosed AML, 60-75 years of
age, who were able to tolerate intensive chemotherapy. This randomized (2:1)
study is designed to compare CPX-351 to the standard of care, commonly
referred to as "7+3." In the "7+3" regimen, cytarabine is administered as a
7 day continuous infusion and daunorubicin is administered on days 1, 2 and 3.
CPX-351, containing both agents at a synergistic ratio, is infused over 90
minutes on days 1, 3 and 5. The primary endpoint of the study is complete
remission rate. Secondary endpoints are duration of complete remission, event
free survival, survival at 12 months, rate of stem cell transplant, 30, 60,
and 90 day mortality, and safety and tolerability.
The Company plans to release interim safety and complete remission data from
the first 80 evaluable patients at the 51st American Society of Hematology
Annual Meeting, December 5-8, 2009, in New Orleans, Louisiana. In addition to
the clinical study results, data will also be presented on the improved
selectivity of CPX-351 for leukemic cells over normal bone marrow cells.
About CPX-351
CPX-351 represents a new approach to combination therapy for cancer in which
synergistic molar ratios of combined drugs 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. In addition to the present
trial, it is being compared to intensive salvage therapy in a Phase 2
multicenter, randomized, open-label clinical trial in adult patients (up to 60
years old) with AML in first relapse, a study supported through a partnership
with The Leukemia & Lymphoma Society® (LLS).
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: CPX-351 (a liposomal formulation of
cytarabine:daunorubicin), currently in Phase 2 in patients with acute myeloid
leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine), currently
in Phase 2 in patients with colorectal cancer; CPX-571 (a liposomal
formulation of irinotecan:cisplatin), a preclinical stage compound; and
multiple research programs. Based on the applications of CombiPlex, Celator is
positioned to advance a broad pipeline of combination 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 at www.clinicaltrials.gov.
SOURCE Celator Pharmaceuticals
Mike Beyer of Sam Brown, Inc., +1-773-463-4211, beyer@sambrown.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.



Follow Reuters