Gloucester Pharmaceuticals to Present Positive Results from Multiple Romidepsin Clinical Trials at the ASH Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 20, 2008 - Gloucester Pharmaceuticals today announced four presentations from clinical trials of romidepsin at the upcoming 50th American Society of Hematology (ASH) Annual Meeting being held in San Francisco, CA, December 6 – 9, 2008. Romidepsin is a novel, cyclic peptide, histone deacetylase (HDAC) inhibitor under investigation for hematologic malignancies including cutaneous T-cell Lymphoma (CTCL), peripheral T-cell lymphoma (PTCL) and multiple myeloma.
The schedule and abstract information for these presentations is as follows:
Saturday, December 6, 5:30 – 7:30 PM Pacific Time: Poster Presentations at the Lymphoma: Chemotherapy and Clinical Trials Session
- Publication #1567 entitled “Results of a Phase 2 NCI Multicenter Study of Romidepsin in Patients with Relapsed Peripheral T-Cell Lymphoma (PTCL)” presented by Richard Piekarz of the National Cancer Institute. Location: Moscone Center, Hall A, Poster Board # I-672
- Publication #1568 entitled “Final Clinical Results of a Phase 2 NCI Multicenter Study of Romidepsin in Recurrent Cutaneous T-Cell Lymphoma (CTCL)” presented by Susan Bates of the National Cancer Institute. Location: Moscone Center, Hall A, Poster Board # I-673
Monday, December 8, at 7:15 AM Pacific Time: Oral Presentation at the Targeted Therapies and New Agents in Lymphoma Session
- Publication #263 entitled “Clinically Significant Responses Achieved with Romidepsin in Treatment-Refractory Cutaneous T-Cell Lymphoma (CTCL): Final Results from a Phase 2B, International, Multicenter, Registration Study” presented by Youn H. Kim of Stanford Comprehensive Cancer Center. Location: Moscone Center, 2005-2007-2018-2020 - West
Monday, December 8, 5:30 – 7:30 PM Pacific Time: Poster Presentation at the Myeloma – Therapy, excluding Transplantation Session
- Publication #3698 entitled “High Response Rates with the Combination of Bortezomib, Dexamethasone and the pan-Histone Deacetylase Inhibitor Romidepsin in Patients with Relapsed or Refractory Multiple Myeloma in a Phase I/II Clinical Trial” presented by Simon J. Harrison of the Peter MacCallum Cancer Centre, Melbourne. Location: Moscone Center, Hall A, Poster Board # III-780
About Romidepsin
Romidepsin is a late-stage oncology drug candidate being studied across a range of hematologic malignancies. A registration trial in cutaneous T-cell lymphoma (CTCL) has recently been completed, successfully exceeding its primary endpoint based on overall response rate. A registration trial in a second indication, peripheral T-cell lymphoma (PTCL), is currently enrolling patients. Complete and durable responses were observed in a previous National Cancer Institute trial including both patients with CTCL and PTCL. Numerous other trials are ongoing in additional indications including multiple myeloma. Over 750 patients, to date, have received romidepsin in clinical trials with the most common adverse effects including fatigue, gastrointestinal disturbances and generally mild to moderate bone marrow suppression. Romidepsin's cyclic peptide structure is novel among members of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDAC inhibition has been shown to increase acetylation of histones and other proteins. The downstream effects of HDAC inhibition include growth inhibition, apoptosis, inhibition of angiogenesis and differentiation. Preclinical studies suggest that romidepsin is a pan-HDAC inhibitor and is a potent inhibitor of Class I, Class II and Class IV HDACs. Gloucester Pharmaceuticals retains worldwide rights to romidepsin which received Orphan Drug Designation from the FDA for the treatment of non-Hodgkin's T-cell lymphomas, including CTCL and PTCL and Orphan status from the EMEA for the treatment of both CTCL and PTCL. The FDA has also granted Fast Track status for CTCL and PTCL. An NDA submission for romidepsin in CTCL is anticipated in late 2008 and an MAA submission is projected for 2009.
About Gloucester Pharmaceuticals
Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company's first candidate, romidepsin, a novel HDAC inhibitor, is in late-stage development for T-cell lymphomas and has shown activity across a range of hematological malignancies. Gloucester has completed a registration trial of romidepsin in patients with cutaneous T-cell lymphoma (CTCL) and expects to submit applications for marketing approval in the US in 2008 and the EU in 2009. The Company is currently enrolling patients in a registration trial for peripheral T-cell lymphoma (PTCL) and is evaluating romidepsin in multiple additional indications including multiple myeloma. For more information, please visit www.gloucesterpharma.com.
Contact: MacDougall Biomedical Communications
Sarah Cavanaugh, 781-235-3060
Posted: November 2008
