Cleveland BioLabs and Incuron Announce CBL0102 Orphan Drug Status for Hepatocellular Carcinoma
Cleveland BioLabs, Inc. (Nasdaq: CBLI) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that curaxin CBL0102 (quinacrine) has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for treatment of hepatocellular carcinoma.
A multi-center Phase I trial of CBL0102 is ongoing in the Russian Federation in patients with liver metastases of solid tumors of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist. The trial is dosing the sixth cohort in its dose-escalation arm and, subsequent to the completion of the dose-escalation arm, will enroll an efficacy arm.
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