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Gloucester Pharmaceuticals Reports on Data From Clinical Studies Presented By the NCI at The American Society of Clinical Oncology Annual Meeting; Encouraging Results Seen in Phase II Trial for Peripheral T-Cell Lymphoma

Posted on: Tuesday, 24 May 2005, 09:00 CDT

Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, today reported on data from two separate clinical trials of its lead product candidate, FK228 (depsipeptide), presented at the American Society of Clinical Oncology Meeting held recently in Orlando, Florida. The studies were sponsored by the National Cancer Institute (NCI) and conducted under a Cooperative Research and Development Agreement (CRADA) between Gloucester Pharmaceuticals and the NCI. Gloucester is currently sponsoring a pivotal trial of FK228 in patients with cutaneous T-cell lymphoma.

Richard Piekarz, M.D., Ph.D. of the NCI presented data in a poster session entitled "Response and molecular markers in patients with peripheral T-cell lymphoma (PCTL) treated on a phase II trial of depsipeptide, FK228." Objective responses were observed in 5 of 19 patients with relapsed or refractory PTCL, including 2 complete responses and 3 partial responses. The duration of response ranged from 8-14 months, with one patient having an ongoing, complete response at 14 months.

"Peripheral T-cell lymphoma is one of several aggressive forms of non-Hodgkin's lymphoma," commented William McCulloch, M.B., FRCP, Executive Vice-President and Chief Medical Officer at Gloucester Pharmaceuticals. "At the time of diagnosis these lymphomas are often at relatively advanced stages, and require prompt treatment. The data presented by Dr. Piekarz demonstrate that, in the trial, FK228 had significant activity when used as single-agent therapy for patients with PTCL who have been unresponsive to current treatments."

In a second poster session entitled "A Phase I trial and pharmacokinetic study of depsipeptide in pediatric patients with refractory solid tumors: A Children's Oncology Group Study", Maryam Fouladi, MD, Department of Hematology-Oncology, St Jude Children's Research Hospital presented data on 18 evaluable pediatric patients with a variety of solid tumors. Results of the trial included three patients who experienced stable disease in pediatric cancers (1 rhabdomyosarcoma, 1 ependymoma and 1 peripheral primitive neuroectodermal tumor), following 4 or more courses of therapy. Overall, FK228 was found to be relatively well tolerated in children at the appropriate dose level, with a similar pharmacokinetic profile observed in adults.

About PTCL

Peripheral T-cell lymphoma (PTCL), a type of non-Hodgkin's lymphoma, is associated with a very poor outcome. It is characterized by cancerous T-cells that circulate in the blood and collect in the skin, forming nodules. PTCL is more common in adults than children and is typically treated with combination chemotherapy.

About FK228

FK228 is one of a new class of anti-cancer agents, known as histone deacetylase inhibitors. FK228 was granted Fast Track and Orphan Drug designations by the Food and Drug Administration and European Orphan Drug designation by the EMEA as a monotherapy for the treatment of cutaneous T-cell lymphoma in patients who have relapsed following, or become refractory to, one other systemic therapy. Gloucester is currently conducting a pivotal clinical trial of FK228 for this indication. FK228 is also being studied in a range of hematologic and solid tumor indications including hormone refractory prostate cancer in clinical trials sponsored by Gloucester, as well as the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA).

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. The company employs an in-licensing strategy to build a diversified product portfolio to address the significant unmet medical need in the management of cancer. Gloucester's first product is FK228, a novel HDAC inhibitor. The Company is headquartered in Cambridge, MA.

For more information visit our website at www.gloucesterpharma.com.

This press release contains forward-looking statements concerning Gloucester that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes,""anticipates,""plans,""expects,""estimates,""intends,""should,""could,""will,""may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Gloucester's actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in pre-clinical and early clinical studies such as the results referred to in this release will be indicative of results obtained in future clinical trials; whether FK228 will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and for which indications, if any; and whether the patent and patent applications owned or licensed by Gloucester will protect the Company's technology and prevent others from infringing it. Gloucester disclaims any intention or obligation to update any forward-looking statements.

Source: Business Wire

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