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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." |
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