Celator Pharmaceuticals
announced that the U.S. Food & Drug Administration (FDA) has granted orphan
drug designation to CPX-351 (Cytarabine:Daunorubicin) Liposome Injection
for the treatment of Acute Myeloid Leukemia (AML).
Celator is currently preparing to conduct two randomized Phase 2
studies with CPX-351. The first Phase 2 study, in newly diagnosed, elderly
patients with AML, is expected to start enrolling patients before the end
of 2008. The second study, in AML patients who have relapsed following
initial treatment, is projected to start enrolling patients in the first
quarter of 2009.
Interim Phase 1 data with CPX-351, where complete remissions were
obtained in patients with advanced leukemia, were reported in December
2007. The company submitted additional CPX-351 preclinical and clinical
data to this year's American Society of Hematology (ASH) meeting in
December and will report Phase 1 results at that time.
CPX-351 is a liposomal formulation of cytarabine and daunorubicin
delivered in a 5:1 molar ratio shown to be strongly synergistic in
preclinical studies. CPX-351 was developed using Celator's proprietary
CombiPlex(R) technology platform.
Orphan drug status is granted to treatments for diseases that affect
fewer than 200,000 people in the United States and provides the benefits of
market exclusivity for seven years, tax credits, and a waiver of FDA user
fees.
"The decision by FDA to grant CPX-351 orphan drug designation
reinforces the importance of developing novel products for the treatment of
rare diseases and represents another milestone for the company," said Scott
Jackson, chief executive officer of Celator Pharmaceuticals. "We are
committed to developing products that will benefit patients and look
forward to initiating enrollment in our CPX-351 Phase 2 program."
About Acute Myeloid Leukemia (AML)
The National Cancer Institute defines AML as a quickly progressing
disease in which too many immature white blood cells (not lymphocytes) are
found in the blood and bone marrow. In 2008, the American Cancer Society's
Cancer Facts and Figures estimates that there will be 13,290 new cases of
AML and 8,820 deaths caused by AML.
About Celator
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(R), the company's
drug ratio technology platform, represents a revolutionary new approach to
the development of combination therapies based on identifying a fixed,
synergistic ratio of the drugs pre-clinically, incorporating that ratio in
a drug delivery vehicle and maintaining the ratio in patients. The company
pipeline includes: CPX-1 (a liposomal formulation of
irinotecan:floxuridine), currently in a Phase 2 trial in patients with
colorectal cancer; CPX-351 (a liposomal formulation of
cytarabine:daunorubicin), currently in a Phase 1 trial in patients with
advanced leukemia; 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 celatorpharma .
Celator Pharmaceuticals
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