Gloucester Pharmaceuticals To Present New Data From Two Studies On Romidepsin At ASCO

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Cancer / Oncology;  Blood / Hematology
Article Date: 31 May 2009 - 0:00 PDT

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Gloucester Pharmaceuticals announced that results from two studies of romidepsin, its novel, cyclic peptide, histone deacetylase inhibitor under investigation for the treatment of hematologic malignancies, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida on Saturday, May 30, 2009.

Poster Q11 #8546 entitled "Pooled analyses of 2 international, multicenter clinical studies of romidepsin in 167 patients with cutaneous T-cell lymphoma (CTCL)" by M Demierre, S Whittaker, Y Kim, E Kim, R Piekarz, M Prince, J Nichols, J Balser, A Prentice and S Bates, describes clinical results from a pooled analysis of two Phase 2 international studies of romidepsin in cutaneous T-cell lymphoma (CTCL).

Poster S13 #8584 entitled "Histone deacetylase inhibitors potently synergize the antineoplastic effects of the proteasome inhibitor bortezomib in mantle cell lymphoma (MCL)" by L Paoluzzi, L Scotto, Seshan and O O'Connor, describes data from a preclinical study of romidepsin in combination with Velcade® (bortezomib) in mantle cell lymphoma (MCL). This study was conducted in collaboration with researchers from the Herbert Irving Comprehensive Cancer Center, College of Physicians and Surgeons, The New York Presbyterian Hospital and Columbia University.

Both posters will be presented during the General Poster Sessions Saturday, May 30, 2009 from 8:00am - 12:00pm ET on Level 2 of West Hall C at the Orlando Convention Center.

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 hematologic toxicities. 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 U.S. Food and Drug Administration (FDA) for the treatment of non-Hodgkin's T-cell lymphomas, including CTCL and PTCL, and Orphan status from the European Medicines Agency (EMEA) for the treatment of both CTCL and PTCL. The FDA has also granted Fast Track status for CTCL and PTCL. A New Drug Application submission for romidepsin in CTCL was accepted by the FDA and a PDUFA is scheduled in November of 2009.

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Gloucester Pharmaceuticals