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Gloucester Pharmaceuticals Announces Positive Interim Results
of Phase I/II Study in Patients with Multiple Myeloma at the
2007 American Society of Hematology (ASH) Annual Meeting
--80% overall response rate reported with romidepsin/bortezomib
(VELCADE®)/ dexamethasone combination in patients with relapsed/refractory
multiple myeloma--
Cambridge, MA
December 10, 2007
Gloucester Pharmaceuticals, Inc., an oncology
focused specialty pharmaceutical company, today announced encouraging
interim results from an investigator-sponsored phase I/II dose-escalation
study investigating the use of the Company's lead product, romidepsin,
in combination with bortezomib (Velcade®) and dexamethasone
to treat patients with relapsed/refractory multiple myeloma. These
interim results were reported at the 49th Annual Meeting of the
American Society of Hematology (ASH) being held in Atlanta, Georgia.
Full text of the abstract #1167 can be viewed on the ASH website
at www.hematology.org.
In a poster session on Saturday, December 8th, Miles Prince, M.D.,
Chair of Clinical Cancer Services at the Peter MacCallum Cancer
Centre, Melbourne, Australia and principal investigator of the
study, presented data on the first 10 evaluable patients enrolled
in the
phase I/II study. An overall response rate of 80% (8/10) was reported,
with one complete response, six partial responses, and one minor
response. The most common adverse events reported included nausea,
fatigue, constipation/diarrhea, and neuropathy. The most common
grade 3/4 event was thrombocytopenia. The phase I dose-escalation
portion of the trial has been completed and the maximum tolerated
dose was determined to be 1.3 mg/m2 of bortezomib, 20 mg of dexamethasone
and 10 mg/m2 of romidepsin. Additional patients are being accrued
at the maximum tolerated dose to assess clinical activity.
"
The 80% overall response rate and the rapid time to response noted
in the interim analysis of this trial is quite encouraging," commented
Dr. Miles Prince. "Although substantial preclinical data exist
demonstrating synergistic activity of romidepsin and bortezomib,
this is the first time the combination has been tested in patients.
We were certainly hoping to see such positive results for the patients
in the clinical trial and are very pleased with the responses to
date."
William McCulloch, M.B., FRCP, Executive Vice-President and Chief
Medical Officer at Gloucester Pharmaceuticals said, "The preliminary
data emerging from this trial further support the potential broad
utility of our novel histone deacetylase inhibitor, romidepsin,
as monotherapy or in combination with other anti-cancer agents.
Romidepsin has already been shown to have clinical activity as a
single-agent in the treatment of T-cell lymphomas, and we believe
the combination of romidepsin, dexamethasone and bortezomib may
have the potential to provide similar benefit to multiple myeloma
patients."
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