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Gloucester Pharmaceuticals Reports Positive
Interim Phase II Data on Romidepsin for Peripheral T-Cell Lymphoma
at the 2006 American Society of Hematology (ASH) Annual Meeting
--durable complete responses observed in various
subtypes of peripheral T-cell lymphoma (PTCL) with single-agent
romidepsin--
--Company expects to initiate a pivotal study
in PTCL in early 2007-
Cambridge, MA
December 12, 2006
Gloucester Pharmaceuticals, Inc., a privately
held cancer therapeutics development company, today announced interim
data for romidepsin (formerly known as depsipeptide, FK228) as
a treatment for peripheral T-cell lymphoma (PTCL) at the American
Society of Hematology Annual Meeting held in Orlando, FL. The data
presented are part of an interim analysis of a phase II study sponsored
by the National Cancer Institute (NCI) under a Cooperative Research
and Development Agreement (CRADA) with Gloucester.
Dr. Richard L.
Piekarz of the National Cancer Institute and a principal investigator
in the NCI’s ongoing clinical trial
of romidepsin presented Abstract #2469 “Phase II Trial of
Romidepsin, FK228, in Cutaneous and Peripheral T-Cell Lymphoma:
Clinical Activity and Medical Markers” in a general poster
session on Sunday, December 10th.
The interim results reported on
36 patients with PTCL. An overall response rate of 30% (11/36)
was reported, with 3 complete responses
(8%) and 8 partial responses (22%). The median duration of response
in PTCL was reported as 12+ months. Overall, the most common
adverse events reported were fatigue, nausea, and vomiting. In
a separate
release issued today Gloucester announced the interim results
from this trial for 42 patients with cutaneous T-cell lymphoma
(CTCL).
Commenting on the Piekarz poster presentation,
Jean Nichols, Ph.D., Executive Vice President and Chief Scientific
Officer at
Gloucester
said, “We are quite encouraged with the results reported
for peripheral T-cell lymphoma. Significant clinical responses
have now been observed in peripheral T-cell and cutaneous T-cell
lymphoma patients, suggesting that romidepsin has activity in multiple
T-cell lymphomas.” Dr. Nichols further commented, “Based
on this encouraging data, we expect to initiate a Gloucester-sponsored
international pivotal study in PTCL in the first quarter of 2007.”
About
PTCL
Peripheral T-cell lymphoma accounts for about 10-15% of all
cases of non-Hodgkin’s lymphoma. It can occur at any age
from young adulthood to old age and is slightly more common in
men than in
women. PTCL is a particularly aggressive form of lymphoma with
a short median duration of life expectancy (approximately two years)
from diagnosis.
About Romidepsin (Depsipeptide)
In July 2006
the International Nonproprietary Names (INN) body of the World
Health Organization (WHO) and the United States Adopted
Names (USAN) Council approved the nonproprietary (generic) name
romidepsin for depsipeptide (FK228). Romidepsin is a novel agent
in a new class of anti-cancer drugs known as histone deacetylase
inhibitors. The Company is conducting a pivotal study of romidepsin
for patients with cutaneous T-cell lymphoma (CTCL). Romidepsin
has received both Fast Track and Orphan Drug Designation by the
Food and Drug Administration (FDA), and Orphan Drug Designation
from the European Agency for the Evaluation of Medicinal Products
(EMEA). Romidepsin is also in clinical trials for a variety of
other hematologic malignancies and solid tumors including peripheral
T-cell lymphoma, hormone refractory prostate cancer and multiple
myeloma. These trials and others are being conducted by the Company
or the National Cancer institute (NCI), under a Cooperative Research
and Development Agreement (CRADA) with the Company.
About Gloucester
Pharmaceuticals, Inc.
Gloucester Pharmaceuticals, Inc. is a privately
held, venture-backed company that develops and commercializes innovative
products for
the treatment of cancer patients. Gloucester is headquartered in
Cambridge, MA. For more information on Gloucester and our clinical
development program visit our website at www.gloucesterpharma.com or call 888-GPI-CTCL (888-474-2825).
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