GLOUCESTER PHASE 2 CLINICAL TRIAL WITH FK228 ENCOURAGING.
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.
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.
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.
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|Date:||Aug 1, 2004|
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