To Err is Human …
Zentiva Co, Prague
Keywords: ONC201, patent protection, clinical studies, isomer mismatch, analytical control
The compound originally known as TIC10 or ONC201 is a new anticancer drug developed by Oncoceutics, Inc. The agent's Investigational New Drug Application for phase I/II clinical studies has been recently approved by Food & Drug Administration. However, a Scripp Institute’s group revealed that the compound structure given in all documents, including patents, was erroneous and applied for a patent protection for the correct structure. Chemistry backgrounds associated with this case is reviewed together with the relevant consequences regarding the intellectual property issue.
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