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Gloucester Pharmaceuticals Reports Clinically Significant Responses in Pivotal Trial of Romidepsin for Cutaneous T-cell Lymphoma at the 2007 American Society of Hematology (ASH) Annual Meeting
Cambridge, MA - December 10, 2007 - Gloucester Pharmaceuticals, Inc., a privately
held cancer therapeutics development company, announced today that preliminary results
from the pivotal trial of romidepsin, the Company's novel histone deacetylase inhibitor,
for cutaneous T-cell lymphoma (CTCL) were presented at the American Society of Hematology
(ASH) Annual Meeting held in Atlanta, Georgia. Youn H. Kim, M.D. of the Stanford
Comprehensive Cancer Center and an investigator in the study presented data on romidepsin
in an oral session entitled "Romidepsin (depsipeptide) Induces Clinically Significant
Responses in Treatment-Refractory CTCL: An International, Multicenter Study". Full
text of the abstract #123 can be viewed on the ASH website at www.hematology.org.
The results reported by Dr. Kim included 73 evaluable CTCL patients. An overall
response rate of 37% (27/73) was reported, with four complete responses (6%), 23
partial responses (31%) and 40 patients with stable disease (55%). Six patients
had progressive disease. Significant pruritus relief was observed in 37% of patients
who had severe pruritus at baseline. Additionally, 38% of the patients who exhibited
any pruritus at baseline reported significant relief from symptoms. Overall, the
most common adverse events reported were nausea, fatigue, vomiting, aguesia, headache
and anorexia. Minor ECG abnormalities that were asymptomatic, transient and did
not generally affect drug administration or the ability to continue therapy were
noted in 6% of patients.
"We are very pleased with the promising clinical results from our ongoing pivotal
study in CTCL," commented William McCulloch, M.B., FRCP, Executive Vice-President
and Chief Medical Officer at Gloucester Pharmaceuticals. "Romidepsin continues to
demonstrate significant single-agent activity in the treatment of T-cell lymphomas
as well as encouraging clinical response in combination with other cancer agents
with a manageable toxicity profile."
About the Pivotal Trial
GPI-04-0001 is a Phase II, non-randomized, open-label, single-arm
international, multi-center study designed to evaluate the efficacy, safety and
tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL).
Study patients receive romidepsin at a dose of 14 mg/m2 intravenously over 4 hours
on days 1, 8 and 15 of each 28-day cycle. The duration of study treatment is 6 cycles
although patients who show an objective response or stable disease may continue
to receive therapy, at the discretion of the investigator and patient, until disease
progression or another withdrawal criterion is met.
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 Romidepsin
Romidepsin is a novel histone deacetylase inhibitor. Gloucester
is currently conducting a pivotal phase II study with romidepsin for patients with
peripheral T-cell lymphoma (PTCL). The company recently completed its pivotal phase
II study with romidepsin for patients with cutaneous T-cell lymphoma (CTCL). Romidepsin
has received Orphan Drug Designation from the Food and Drug Administration (FDA)
for the treatment of non-Hodgkin T-cell lymphomas, which include 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 also
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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For more information, please contact:
Media
Kathryn Morris
KMorrisPR
Email: kathryn@kmorrispr.com
Tel: (845) 635-9828
For Gloucester Pharmaceuticals
Beverly Holley
Email: beverly@gloucesterpharma.com
Tel: (617) 583-1362 or (781) 235-9803