Gloucester Pharmaceuticals Initiates Phase I/II Clinical Study in Pancreatic and Other Advanced Solid Tumors; Combination Trial Will Investigate Romidepsin (Depsipeptide) in Combination with Gemcitabine.CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, announced today that it has enrolled and treated the first patient in a phase I/II clinical study of romidepsin in combination with gemcitabine to treat pancreatic cancer and other solid tumors.
The Company anticipates enrolling approximately 30 patients in an open-label, single-arm study. Patients will receive romidepsin and gemcitabine at various doses in order to establish the most appropriate dose for each drug in this combination regimen. Once the appropriate dose of each drug is determined, additional patients will be treated at that dosing regimen. The endpoints for this trial include both safety and objective response to therapy.
"This clinical trial will expand on recent preclinical data suggesting that romidepsin may enhance the activity of gemcitabine," commented Howard Burris, M.D., of the Sarah Cannon Research Institute and principal investigator of the study. "Gemcitabine is already approved for the treatment of pancreatic cancer and we hope to find that using it in combination with romidepsin may improve patient outcomes. Despite recent advances, pancreatic cancer is still a leading cause of cancer death in the United States and innovative new treatments are clearly needed," he concluded.
About Romidepsin (Depsipeptide)
In July 2006 the International Nonproprietary Names (INN) body of the World Health Organization (WHO) and the United States Adopted Names United States Adopted Names See USAN. (USAN USAN United States Adopted Name.
United States Adopted Names (used for nonproprietary names of drugs adopted by a committee of medical professionals and drug manufacturers)
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 Cutaneous T-Cell Lymphoma Definition
Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system.
Description (CTCL CTCL Cutaneous T Cell Lymphoma ). Interim data for this trial, recently presented at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. meeting, included 40 patients enrolled and 28 evaluable patients. The overall response rate was 36% (10/28) with 7% of patients achieving a complete response. The most common adverse events seen in this trial were nausea (52%), fatigue (33%) and vomiting (26%). This study is currently accruing patients. Romidepsin has received both Fast Track and Orphan Drug Designation by the Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ), and Orphan Drug Designation from the European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ). 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 See Liberate. ), under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).
A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) 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).
Information on Gloucester's clinical trials can also be found at:
www.clinicaltrials.gov/ct/show/NCT00106431 regarding cutaneous T-cell lymphoma
www.clinicaltrials.gov/ct/show/NCT00106418 regarding prostate cancer