Press Release: Gloucester Pharmaceuticals Reports Clinically Significant Responses in Interim Analysis of Pivotal Trial
Gloucester Pharmaceuticals Reports Clinically Significant Responses in Interim Analysis of Pivotal Trial for Cutaneous T-Cell Lymphoma at the 2006 American Society of Hematology (ASH) Annual Meeting Complete Clinical Responses and Signficant Pruritus Relief Reported with Single-Agent Romidepsin CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, announced today interim data for romidepsin (formerly known as depsipeptide, FK228), the Companyâ€™s novel histone deacetylase inhibitor, at the American Society of Hematology Annual Meeting held in Orlando, FL. Data were presented on two studies: a Gloucester-sponsored pivotal phase II trial of romidepsin for patients with treatment refractory cutaneous T-cell lymphoma (CTCL); and a phase II study sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Gloucester. â€œThe data emerging from Gloucesterâ€™s pivotal trial and the NCI-sponsored trial support our regulatory strategy for gaining approval of romidepsin as a monotherapy for relapsed or refractory CTCL,â€ commented William McCulloch, M.B., FRCP, Executive Vice-President and Chief Medical Officer at Gloucester Pharmaceuticals. â€œThe most promising aspects of the interim data are the significant pruritus relief and complete responses that we have seen,â€ added Dr. McCulloch. â€œIt is important to note that these results, especially the pruritus relief, have been achieved without the concurrent use of either steroids and/or antihistamines which are known to enhance such clinical effects.â€ Gloucester-Sponsored Pivotal Trial The interim results reported for the Gloucester-sponsored pivotal phase II trial included 38 evaluable CTCL patients. An overall response rate of 32% (12/38) was reported, with three complete responses (8%), nine partial responses (24%) and 22 patients with stable disease (58%). Three patients had progressive disease. Significant pruritus relief was observed in 88% of patients who had severe pruritus at baseline. Additionally, 53% of patients who exhibited any pruritus at baseline reported significant relief from symptoms. Overall, the adverse events have been manageable, with the most common being mild-to-moderate nausea, fatigue, and vomiting. In a separate release issued today Gloucester announced the interim results from this trial for 36 patients with peripheral T-cell lymphoma (PTCL). Adam Lerner, MD, Associate Professor of Medicine, Boston University School of Medicine presented the data on Sunday, December 10th in a general poster session entitled Abstract #2468 â€œRomidepsin (Depsipeptide, FK228) Induces Clinically Significant Responses in Treatment-Refractory CTCL: Interim Report of a Phase II Multicenter Studyâ€. â€œThe low rate of treatment discontinuation in this trial due to side effects and the prolonged treatment duration of some patients illustrate that toxicity has been manageable,â€ commented Dr. Lerner. He also noted, â€œThe patient benefits of both response to therapy and relief of symptoms, such as pruritus, are important goals for both patients and physicians. The data, to date, suggest that romidepsin has the potential to become an important component of our treatment regimen for this disease.â€ NCI Phase II Trial Dr. Richard L. Piekarz of the National Cancer Institute and a principal investigator in the NCIâ€™s ongoing clinical trial of romidepsin presented Abstract #2469 â€œPhase II Trial of Romidepsin, FK228, in Cutaneous and Peripheral T-Cell Lymphoma: Clinical Activity and Medical Markersâ€ in a general poster session on Sunday, December 10th. The interim results reported for the NCI-sponsored phase II trial included 42 patients with CTCL. An overall response rate of 31% (13/42) was reported, with 3 complete responses (7%), 10 partial responses (24%) and 10 patients with stable disease (24%). The median duration of response in CTCL was reported as 11 months. Overall, the most common adverse events reported were fatigue, nausea, and vomiting. About CTCL CTCL is a group of diseases, including Mycosis Fungoides and SÃ©zary syndrome, all constituting types of non-Hodgkin's lymphoma in which certain cells of the lymph system (T-cells) become cancerous and affect the skin. The disorder is characterized by abnormal accumulation of malignant T-cells in the skin, which result in the development of itchy rashes, plaques and tumors. Occasionally malignant cells can be found circulating in the bloodstream and visceral (internal organ) involvement can occur. Symptoms of the disorder often include pruritus, an intense itching sensation, which leads to scratching that may cause breaks in the skin that lead to infection. In some patients, pruritus can be so severe that it affects overall quality of life. There are about 40,000 CTCL patients worldwide. About Romidepsin (Depsipeptide) In July 2006 the International Nonproprietary Names (INN) body of the World Health Organization (WHO) and the United States Adopted Names (USAN) Council approved the nonproprietary (generic) name romidepsin for depsipeptide (FK228). Romidepsin is a novel agent in a new class of anti-cancer drugs known as histone deacetylase inhibitors. The Company is conducting a pivotal study of romidepsin for patients with cutaneous T-cell lymphoma (CTCL). Romidepsin has received both Fast Track and Orphan Drug Designation by the Food and Drug Administration (FDA), and Orphan Drug Designation from the European Agency for the Evaluation of Medicinal Products (EMEA). Romidepsin is also in clinical trials for a variety of other hematologic malignancies and solid tumors including peripheral T-cell lymphoma, hormone refractory prostate cancer and multiple myeloma. These trials and others are being conducted by the Company or the National Cancer institute (NCI), under a Cooperative Research and Development Agreement (CRADA) with the Company. 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-GPI-CTCL (888-474-2825).