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

al activity of belinostat has been observed in an ongoing Phase II trial of belinostat monotherapy in patients with recurrent or refractory cutaneous (CTCL) or peripheral T-cell lymphoma (PTCL). Efficacy is being analyzed separately in PTCL and CTCL patients. In 11 patients evaluable for response in the PTCL arm, 2 durable complete responses (CR) and 4 Stable Diseases (SD) have been observed as announced at "10th International Conference on Malignant Lymphoma" in Lugano in June. In both arms of the study, the objective response rate in the first stage has met the criteria for expansion to the second stage of a Simon 2-stage design.

Objectives and methods of evaluation The primary study endpoint will be objective response rate (ORR). Objective response is complete response (CR) or partial response (PR) based on independent radiology review. Secondary objectives of the study are to determine: safety of belinostat monotherapy, time to response, duration of response, time to progression (TTP), progression-free survival (PFS), one-year progression-free rate, one-year survival rate and overall survival (OS).

Today's news does not change TopoTarget's full-year financial guidance for 2008.

Background information

About Periferal T-Cell Lymphomas (PTCL)

PTCL represent approximately 10% of all non-Hodgkin's lymphomas (NHL) in Western populations and are associated with a poor prognosis. Most patients with PTCL relapse after initial treatment with cytotoxic agents, and 5-year survival is less than 30%. T-cell Non Hodkins Lymphomas, to which PTCL belongs, are associated with a poorer outcome and survival compared to the B-cell lymphomas. The primary response rate for all PTCL subtypes remains at less than 60%, with nearly all patients relapsing. Median survival of all PTCL patients (excluding a few subtypes) is approximately 3-4 years, with a 5-year survival of less than 30%. There are currently no therapies approved specifically for PTCL. Prim
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