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CuraGen and TopoTarget Report Belinostat Results Presented at ASH and Provide Regulatory Update Following End-of-Phase II Meeting with FDA
Date:12/10/2007

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About Peripheral T-cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a type of non-Hodgkin's Lymphoma (NHL) which arises from malignant T-lymphocytes, also known as T-cells, and account for approximately 15%, or more than 5,000 cases, of all NHL cases diagnosed in the U.S. PTCL tends to be an aggressive form of NHL with a five-year survival of less than 30%. There are currently no FDA approved drugs for the treatment of PTCL.

About Belinostat

Belinostat is a small molecule histone deactylase (HDAC) inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies as a single-agent and in combination with other active anti-cancer agents, including carboplatin, paclitaxel, cis-retinoic acid, azacitidine, idarubicin and bortezomib. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes and have been shown to arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents.

Intravenous belinostat is currently being evaluated in multiple clinical trials as a potential treatment for cutaneous and peripheral T-cell lymphomas, B-cell lymphomas, AML, mesothelioma, soft tissue sarcoma, myelodysplastic syndrome, and liver, colorectal, and ovarian cancers, either alone or in combination with other anti-cancer therapies. An oral formulation of belinostat is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors. In August 2004, CuraGen signed a Clinical Trials Agreement with the NCI under which the NCI will sponsor several clinical trials to investigate belinostat for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens. In May 2005, TopoTarget announced the signing o
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