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FDA Grants Orphan Drug Designation to CPI-613 for the Treatment of Peripheral T-Cell Lymphoma

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The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma. CPI-613 is a novel lipoic acid analog with an anticancer activity that inhibits multiple enzyme targets within the tricarboxylic acid cycle. This drug is currently under investigation in combination with bendamustine in patients with relapsed or refractory T-cell lymphoma.

T-cell lymphomas account for 10% to  15% of lymphoid malignancies and display significant heterogeneity. T-cell lymphomas have a worse prognosis than most B-cell lymphomas. There is no standard treatment for relapsed or refractory disease, and median progression-free and overall survival rates have been reported as 3.7 and 6.5 months, respectively.

Study Details

Ten patients were dosed to date, and seven were evaluated for efficacy. The interim results of CPI-613 in combination with bendamustine in patients with T-cell lymphoma exhibited an 86% objective response rate (43% complete response and 43% partial response). The results from this study were first presented by Lamar et al at the 2016 American Society of Hematology Annual Meeting.

The primary objective of the current study is to determine the maximum tolerated dose and safety profile of CPI-613 when used in combination with bendamustine to treat patients with relapsed or refractory T-cell lymphoma or classic Hodgkin Lymphoma.

Rafael Pharmaceuticals recently announced the activation of a second clinical trial site for this study at the Abramson Cancer Center of the University of Pennsylvania, the first site being Wake Forest Baptist Health.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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