Gloucester Pharmaceuticals Reports on Preclinical Study of Depsipeptide in Pancreatic Cancer from the 97th Annual Meeting of The American Association of Cancer Research.

CAMBRIDGE, Mass. -- Significant Preclinical Activity Seen for Depsipeptide in Combination with Gemcitabine

Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, today announced the presentation of preclinical research suggesting the potential of the Company's lead product candidate, depsipeptide (FK228), in combination with gemcitabine, as a treatment for pancreatic adenocarcinoma. The findings were reported at the 97th Annual Meeting of the American Association of Cancer Research (AACR), taking place in Washington, DC. Full text of the abstract #3829 "In Vivo Evaluation of Depsipeptide (FK228) Alone or in Combination with Gemcitabine in Two Human Pancreas Tumor Xenograft Models" can be viewed on the AACR website at www.aacr.org. The study was co-sponsored by the Cancer Therapy and Research Center Institute for Drug Development in San Antonio, Texas and Gloucester Pharmaceuticals.

"The preclinical data in pancreatic cancer models reported at AACR supports our belief that depsipeptide has the potential to treat a variety of solid cancers" noted William McCulloch, M.B., FRCP, Executive Vice-President and Chief Medical Officer at Gloucester Pharmaceuticals. "We expect to initiate clinical trials of depsipeptide in pancreatic cancer later this year," he concluded.

Pancreatic adenocarcinoma is the fourth most common cause of cancer-related mortality in the US with a 4% five year survival rate after diagnosis. Mutation of the K-ras oncogene has been identified in up to 90% of all cases. The frequent detection of mutant ras proteins in pancreatic and other cancers provides strong support for their role as potential drug targets.

In the current study, the anti-tumor activity of depsipeptide was tested - as a single agent and in combination with gemcitabine - in two murine tumor models of pancreatic adenocarcinoma, a mutant ras model (PANC-1) and a wild-type ras model (BxPC-3). Significant activity of the combination of depsipeptide and gemcitabine was observed in the mutant ras PANC-1 model, with marked inhibition of tumor growth and partial tumor regressions, as compared to gemcitabine alone. In addition, the tumor responses were maintained well beyond the last drug administration. Any toxicities observed were mild and reversible following cessation of dosing. The Company believes these results support the concept of ras transformed malignancies as potential clinical targets for depsipeptide in pancreatic and other solid tumors and also demonstrate the potential for depsipeptide to enhance the activity of gemcitabine in mutant K-ras pancreatic cancers.

About Depsipeptide (FK228)

Depsipeptide is a novel agent in a new class of anti-cancer drugs, known as histone deacetylase inhibitors which inhibits histone deacetylase (HDAC), resulting in induction and repression of target genes, G1 and G2/M arrest, cellular differentiation, apoptosis and angiogenesis inhibition. It has also been shown in vitro that depsipeptide treatment can result in morphologic reversion of ras-transformed cells. Depsipeptide is currently in a pivotal study for patients with cutaneous T-cell lymphoma (CTCL). This pivotal trial has undergone Special Protocol Assessment (SPA) by the FDA. Depsipeptide has received Fast Track designation by the FDA and Orphan Drug designation by the FDA and the EMEA as monotherapy for cutaneous T-cell lymphoma patients who have relapsed, or become refractory to, at least one prior systemic therapy. Depsipeptide 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 Gloucester Pharmaceuticals 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. 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 is headquartered in Cambridge, MA. For more information about Gloucester visit our website at www.gloucesterpharma.com.

About the Institute for Drug Development

The Cancer Therapy and Research Center Institute for Drug Development (IDD), located in San Antonio, Texas, conducts the largest oncology Phase I clinical drug trials program in the world. During the past five years, more than 2,600 patients have been treated on new drug protocols at the IDD, and fourteen of the cancer drugs most recently approved by the Federal Drug Administration underwent development or testing at the IDD. Research programs targeted for development over the next several years include genitourinary oncology, breast cancer, gastrointestinal oncology, and genomic and proteomic technology. For more information visit our website at www.idd.org. Or we can be reached through the CTRC's website at www.ctrc.net.

For more information on Gloucester's clinical trials, please call 888-GPI-CTCL (474-2825) or visit www.clinicaltrials.gov/ct/show/NCT00106431 regarding Cutaneous T-Cell Lymphoma or www.clinicaltrials.gov/ct/show/NCT00106418 regarding prostate cancer.