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Positive SPA Reply From the FDA for TopoTarget's Pivotal Trial With Belinostat in PTCL
Date:9/5/2008

ary treatment for most subtypes of PTCL remains anthracycline-based regimens, predominantly the combination of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP). With the exception of ALK-positive ALCL, PTCL subtypes respond poorly to these regimens. The use of radiotherapy, with or without chemotherapy, is preferred as front line treatment of extranodal NK/T-cell lymphoma. The majority of patients with PTCL will relapse after primary therapy. A number of chemotherapy regimens are used for salvage therapy. However, there is currently no consensus regarding the optimal treatment approach for PTCL salvage therapy.

About Belinostat

Belinostat is a promising small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, cis-retinoic acid, azacitidine and Velcade(R) (bortezomib) for injection. 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, MDS, and liver, colorectal, and ovarian cancers, either alone or in combination with anti- cancer therapies. An oral formulation of belinostat is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors. Several trials in the belinostat program are conducted under a Clinical Trail Agreement (CTA) under which the NCI sponsors clinical tri
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