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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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