Printer Friendly

GLOUCESTER PHASE 2 CLINICAL TRIAL WITH FK228 ENCOURAGING.

Gloucester Pharmaceuticals, Inc., Cambridge, Mass. a privately held cancer therapeutics development company, has announced that encouraging interim results from an ongoing NCI-sponsored Phase 2 clinical trial with FK228 (depsipeptide) were presented by Richard Piekarz, M.D., Ph.D., of the National Cancer Institute (NCI), in a poster session entitled "Update on The Phase 2 Trial and Correlative Studies of Depsipeptide in Patients with Cutaneous T-Cell Lymphoma (CTCL) and Relapsed Peripheral T-Cell Lymphoma (PTCL)," at the Annual Meeting of the American Society of Clinical Oncology. The Phase 2 study was sponsored by the NCI under a Cooperative Research and Development Agreement (CRADA) between Gloucester Pharmaceuticals, Inc. and the NCI.

The multi-center, multi-arm Phase 2 trial enrolled patients with CTCL and PTCL. To date, 46 patients have been enrolled in 4 separate arms of the study, based on histology and prior treatment. FK228 is administered using a 4-hour intravenous infusion on days 1, 8 and 15 of a 28-day cycle.

In Arm 1, 9 of 18 patients with CTCL, who had received no more than 2 previous cytotoxic chemotherapy regimens, achieved objective responses for an overall response rate of 50 percent. Of these 9 patients, 3 achieved a complete response. The duration of responses ranged from 6 months to continuing over 38 months.

Data were also presented on 20 patients with PTCL. Of these 20 patients, 5 achieved a partial response for an overall response rate of 25 percent. The duration of response for 2 of the patients was 9 and 12 months; 3 patients are continuing to respond at an earlier stage.

Throughout the study, FK228 was demonstrated to be well tolerated. The most common side effects reported by patients were fatigue and nausea. Non-specific changes on electrocardiograms (ECGs) were also noted, but these changes did not have clinical significance or sequelae. 6 patients, all with objective responses, have received FK228 for 12 to 34 months without evidence of cumulative hematologic or non-hematologic toxicity.

"We are extremely encouraged by the results, to date, with FK228 in patients with CTCL and PTCL," commented Jay Mohr, president and CEO of Gloucester Pharmaceuticals, Inc. "If the objective responses and durability demonstrated by FK228 continue to be seen in our ongoing clinical studies, the drug could provide a much needed therapy for 2 subtypes of T-cell mediated lymphomas that are very difficult to treat."

In addition to the reported studies in CTCL and PTCL, FK228 is being investigated in Phase 2 studies sponsored by Gloucester, specifically in Renal Cell Carcinoma and Hormone Refractory Prostate Cancer. FK228 is also being evaluated in ongoing monotherapy and combination Phase 1 and Phase 2 trials, for other hematologic and solid tumor indications through the CRADA between the NCI and Gloucester.

About FK228

FK228 is one of a new class of anti-cancer agents known as histone deacetylase (HDAC) inhibitors, but it is the only bicyclic peptide in this group. In numerous preclinical studies performed by Fujisawa and others, the inhibition of histone deacetylation, which is instrumental in the regulation of gene expression has caused cell cycle arrest, differentiation and apoptotic cell death in cancer cells of various types. Due to the mechanism of action of HDAC inhibition, HDAC inhibitors are thought to have the potential for improved efficacy over traditional cytotoxic agents. Gloucester acquired FK228 from Fujisawa Pharmaceutical Co, Ltd. in April 2004 under an exclusive, worldwide license agreement.

About CTCL

CTCL is a group of diseases, including Mycosis Fungoides, constituting a type 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. There are about 40,000 CTCL patients worldwide (20,000 US), with another 3,000 (1,500 US) new cases reported each year.

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 lead product is FK228, a novel HDAC inhibitor in Phase 2 studies, which the company acquired from Fujisawa Pharmaceutical Co, Ltd. in April 2004. Gloucester is headquartered in Cambridge, Massachusetts and is backed by Apple Tree Partners, an early stage life sciences venture fund with over $105 million under management.

For more information, visit http://www.gloucesterpharma.com or call 781/235-9803.
COPYRIGHT 2004 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:Biotech Business
Date:Aug 1, 2004
Words:768
Previous Article:BAYLOR LICENSES NOROVIRUS VACCINE TECHNOLOGIES TO LICOCYTE.
Next Article:EXELIXIS STARTS PHASE 3 TRIAL OF XL119 FOR BILE DUCT CANCER.


Related Articles
ERESEARCH GETS CARDIAC SAFETY MONITORING $1.2 MILLION AWARD.
Immunomedics awarded patent for humanized carcinoembryonic antigen antibody.
EXELIXIS STARTS PHASE 3 TRIAL OF XL119 FOR BILE DUCT CANCER.
AVANIR INITIATES PHASE III CLINICAL TRIAL OF NEURODEX.
Osiris Therapeutics receives $50 million to fund 3 ongoing adult stem cell trials.
Companies still hiding drug trial data, medical journals say.
VIOQUEST DOSES FIRST PATIENT IN PHASE I/IIA VQD-001 TRIAL.
MS pills are making news.
CYTRX CLINICAL TRIAL OF ARIMOCLOMOL FOR ALS SHOWS PROMISE.
Biodel receives notice of issuance for United States patent covering lead product candidates.

Terms of use | Privacy policy | Copyright © 2021 Farlex, Inc. | Feedback | For webmasters