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Gloucester Pharmaceuticals Reports Positive Interim Phase II
Data on Romidepsin for T-Cell Lymphomas at the 2007 American
Society of Clinical Oncology Annual
Meeting
--durable complete responses reported in both cutaneous T-cell
lymphoma and peripheral T-cell lymphoma--
Cambridge, MA
June 5, 2007
Gloucester Pharmaceuticals, Inc., a privately
held cancer therapeutics development company, today announced that
data for romidepsin as a treatment for cutaneous T-cell lymphoma
(CTCL) and peripheral T-cell lymphoma (PTCL) were presented at
the American Society of Clinical Oncology (ASCO) Annual Meeting
being held in Chicago, IL. The data presented are part of an interim
analysis of a phase II study of romidepsin sponsored by the National
Cancer Institute (NCI) under a Cooperative Research and Development
Agreement (CRADA) with Gloucester.
Data from the NCI's ongoing clinical trial of
romidepsin was presented in Abstract #8027 "Phase II Trial of Depsipeptide in Patients
with Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma" on
Monday, June 4th.
The interim results reported on 70 patients
with CTCL and 39 patients with PTCL. In the CTCL patient group
4 of 70 patients, or 6%, achieved
a complete response, with the duration of response ranging from
8 to 63+ months. A partial response was observed in 18 of 70 patients,
or 26%, with the duration of response ranging from 1 to 69+ months.
The most common adverse events reported were nausea, vomiting,
fatigue, transient granulocytopenia and thrombocytopenia, and anorexia.
Commenting on the data from the NCI's study,
William McCulloch, M.B., FRCP, Executive Vice President and Chief
Medical Officer
at Gloucester said, "Clinical evidence for romidepsin's value
in the treatment of T-cell lymphomas continues to build. Based
on the data from this trial, as well as interim data from our own
Gloucester-sponsored CTCL pivotal phase II study which is nearing
completion, we remain enthusiastic about the clinical prospects
for romidepsin."
In the PTCL patient group 3 of 39 patients,
or 7%, achieved a complete response, with the duration of response
ranging from 9 to 43+ months.
A partial response was observed in 8 of 39 patients, or 21%, with
the duration of response ranging from 2 to 16+ months. The most
common adverse events reported were nausea, vomiting, fatigue,
transient granulocytopenia and thrombocytopenia, and anorexia.
"
We are impressed about the durability of responses, including both
CRs and PRs, that have been seen in the PTCL patients thus far." said
Jean Nichols, Ph.D., Executive Vice President and Chief Scientific
Officer at Gloucester. "Based on the positive data from this
study, we recently commenced a multinational pivotal phase II study
of romidepsin in PTCL patients who have relapsed or become refractory
following systemic therapy," she concluded.
About CTCL
CTCL is a group of diseases, including Mycosis Fungoides and Sézary
syndrome, all constituting types of non-Hodgkin's lymphoma in which
certain cells of the lymph system (T-cells) become cancerous and
affect the skin. The disorder is characterized by abnormal accumulation
of malignant T-cells in the skin, which result in the development
of itchy rashes, plaques and tumors. Occasionally malignant cells
can be found circulating in the bloodstream and visceral (internal
organ) involvement can occur. Symptoms of the disorder often include
pruritus, an intense itching sensation, which leads to scratching
that may cause breaks in the skin that lead to infection. In some
patients, pruritus can be so severe that it affects overall quality
of life. There are about 40,000 CTCL patients worldwide.
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 Orphan Drug Designation from the Food and Drug
Administration (FDA) for the treatment of non-Hodgkin T-cell
lymphomas, which
includes CTCL and PTCL. In addition, the European Agency for
the Evaluation of Medicinal Products (EMEA) has issued Orphan
Drug
status for the treatment of both CTCL and PTCL. Fast Track
status for CTCL and PTCL has also been designated by the FDA.
Romidepsin
is in clinical trials for a variety of other hematological
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-GPI-CTCL (888-474-2825).
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