CuraGen and TopoTarget Announce Initiation of an NCI-sponsored Phase II Clinical Trial of Belinostat for Thymoma and Thymic...( BRANFORD Conn. Dec. 19 /- CuraGen...)

BRANFORD, Conn., Dec. 19 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous belinostat, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of patients with previously-treated thymoma and thymic carcinoma. This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for belinostat.

The Phase II clinical trial is being led by Giuseppe Giaccone, M.D., Ph.D., Chief, Medical Oncology Branch/CCR/NCI in Bethesda, MD. Patients with either thymoma or thymic carcinoma who have received at least one prior platinum-containing chemotherapy regimen are eligible for enrollment. The trial utilizes a Simon 2-stage design and is expected to enroll up to 33 patients who will receive belinostat administered by intravenous infusion once daily for five days every three weeks. Patients will continue to receive treatment with belinostat until disease progression.

The primary objective of the study is to determine the objective response rate by RECIST criteria. Secondary endpoints include evaluation of the time to response, duration of response, progression-free and overall survival. The pharmacodynamic activity of belinostat will also be evaluated by assessment of protein expression, changes in p21 and protein hyperacetylation, and identification of chromosomal gains or losses. Patients will be enrolled at multiple sites in the United States.

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