Gloucester Pharmaceuticals Reports Clinically Significant Responses in Pivotal Trial of Romidepsin for Cutaneous T-cell Lymphoma at the 2007 American Society of Hematology (ASH) Annual Meeting
The results reported by Dr. Kim included 73 evaluable CTCL patients. An overall response rate of 37% (27/73) was reported, with four complete responses (6%), 23 partial responses (31%) and 40 patients with stable disease (55%). Six patients had progressive disease. Significant pruritus relief was observed in 37% of patients who had severe pruritus at baseline. Additionally, 38% of the patients who exhibited any pruritus at baseline reported significant relief from symptoms. Overall, the most common adverse events reported were nausea, fatigue, vomiting, aguesia, headache and anorexia. Minor ECG abnormalities that were asymptomatic, transient and did not generally affect drug administration or the ability to continue therapy were noted in 6% of patients.
"We are very pleased with the promising clinical results from our ongoing pivotal study in CTCL," commented William McCulloch, M.B., FRCP, Executive Vice-President and Chief Medical Officer at Gloucester Pharmaceuticals. "Romidepsin continues to demonstrate significant single-agent activity in the treatment of T-cell lymphomas as well as encouraging clinical response in combination with other cancer agents with a manageable toxicity profile."
About the Pivotal Trial
GPI-04-0001 is a Phase II, non-randomized, open-label, single-arm international, multi-center study designed to evaluate the efficacy, safety and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients receive romidepsin at a dose of 14 mg/m(2) intravenously over 4 hours on days 1, 8 and 15 of each 28-day cycle. The duration of study treatment is 6 cycles although patients who show an objective response or stable disease may continue to receive therapy, at the discretion of the investigator and patient, until disease progression or another withdrawal criterion is met.
CTCL is a group of diseases, including Mycosis Fungoides and Sezary 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.
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 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 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).
Posted: December 2007