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Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin
in Peripheral T-Cell Lymphoma
2nd fast track designation for romidepsin in the treatment of T-cell lymphomas
Cambridge, MA
May 16, 2007
Gloucester Pharmaceuticals, Inc., an oncology
focused biopharmaceutical company, announced today that the U.S.
Food and Drug Administration (FDA) has granted Fast Track designation
for its novel histone deacetylase inhibitor, romidepsin, for the
monotherapy of previously treated peripheral T-cell lymphoma (PTCL).
The Company had previously announced that it has reached an agreement
with the FDA under the FDA's Special Protocol Assessment (SPA) process
for the design of its registration-directed trial of romidepsin
in patients with PTCL, and that it has received Orphan Drug Status
covering this indication in both the United States and Europe.
"
The receipt of Fast Track Designation for PTCL is an important component
of our overall product development strategy for romidepsin," commented
John McBride, Executive Vice President and Chief Operating Officer
at Gloucester. "We now are extremely well positioned to move
forward with clinical development of romidepsin for PTCL, having
previously secured Orphan Drug Designation and finalized a Special
Protocol Assessment with the FDA for this indication. As a novel
agent in a new class of drugs, histone deacetylase inhibitors, we
believe romidepsin has significant potential as a treatment for
a variety of hematological cancers as well as solid tumors," he
concluded.
At the American Society of Hematology Annual
Meeting held in December 2006 an interim analysis of the NCI's phase
II study of romidepsin
as a treatment for PTCL was presented. 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 overall median duration of response has not yet been
reached but was reported as being greater than 12 months. The
most common adverse events reported were fatigue, nausea, and
vomiting.
About Fast Track Designation
The Fast Track program is designed to facilitate and expedite
the development and review of new products that demonstrate
the potential
to address an unmet medical need for serious or life-threatening
conditions. A New Drug Application (NDA) for a Fast Track
product may be submitted in sections on a rolling basis, rather
than
simultaneously. Fast Track designation may further lead to
a priority review of
an NDA within a 6 month timeframe.
About Special Protocol Assessment
A Special Protocol Assessment is a request for feedback from
the FDA that allows a company to receive official evaluation
and guidance
on the design and size of pivotal clinical trial protocols.
A company can request this formal assessment on a pivotal
trial that is intended
to form the primary basis of an efficacy claim in a New
Drug Application
(NDA).
About PTCL
Peripheral T-cell lymphoma is a term which encompasses a
number of different malignancies of T-cell origin that
account for
about 10-15% of all cases of non-Hodgkin's lymphoma. PTCL
can occur
at any age from young adulthood to old age and is slightly
more common
in men than in women. It is a particularly aggressive
form of lymphoma with a short median duration of life expectancy
(approximately
two
years) from diagnosis.
About Romidepsin
Romidepsin is a novel agent in a new class of anti-cancer
drugs known as histone deacetylase inhibitors. The Company
is conducting
a pivotal phase II study of romidepsin for patients with
cutaneous T-cell lymphoma (CTCL) and has initiated a pivotal
phase II
study for patients with peripheral T-cell lymphoma (PTCL).
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) for CTCL. It has also received Orphan Drug Designation
for PTCL from both the FDA and EMEA. Romidepsin is in clinical
trials
for a variety of other hematologic malignancies and solid
tumors including hormone refractory prostate cancer, pancreatic
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 888-474-2825.
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