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
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/m(2) of bortezomib, 20 mg of dexamethasone and 10 mg/m(2) 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."
About the Phase I/II Trial
The investigator-sponsored trial is an ongoing, open-label, single-center, single-arm phase I/II dose-escalation trial of bortezomib, dexamethasone and romidepsin in patients with relapsed or refractory multiple myeloma. All patients receive bortezomib (1.3 mg/m(2) on days 1, 4, 8 and 11) with dexamethasone (20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12). The dose escalation of romidepsin commenced at a dose of 8 mg/m(2) intravenously on days 1, 8, and 15 every 28 days and involved an initial accelerated dose escalation phase, with intra-patient dose escalation of romidepsin. Response rates are assessed according to M-protein response criteria, with complete responses documented by stringent EBMT criteria.
About Multiple Myeloma
Multiple Myeloma is a type of blood cancer in which plasma cells grow, divide and accumulate in the bone marrow, resulting in the decreased production of normal red and white blood cells as well as the decreased production of disease-fighting antibodies. The American Cancer Society estimates that there will be 19,900 new cases of multiple myeloma diagnosed in the United Sates in 2007.
Romidepsin is a novel histone deacetylase inhibitor. Gloucester is conducting pivotal phase II studies of romidepsin for patients with cutaneous T-cell lymphoma (CTCL) and 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's 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 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, by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with the Company or by Investigator-Sponsors.
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 888-474-2825.
Posted: December 2007