ENMD-2076 CASI obtained orphan drug designation from the FDA for treating HCC -
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a pharmaceutical company clinical stage developer of therapies for cancer and other diseases, announced today that its, oral inhibitor of the Aurora / angiogenic kinase, ENMD-2076 received orphan drug designation from the US Food and Drug administration (FDA) for the treatment of hepatocellular carcinoma (HCC).
orphan drug designation is granted by the FDA Office of Orphan Products Development, which evaluates scientific applications and clinical sponsors of data to identify and designate products as promising for rare diseases and to advance scientific development of these promising medical products. Orphan drug designation is granted to therapeutics for treatment of rare diseases affecting fewer than 0,000 people in the US The designation allows the developer to seven years of market exclusivity as well as opportunities for additional funding and using the protocol experts.
Dr. Ken Ren, CEO of CASI, commented: "We are pleased with the orphan drug designation because it confirms our belief in the versatility of ENMD-2076 as a promising treatment for HCC, and for other types of tumors that we are currently assessing the status of clinical medicine. Orphan also enhances the commercial value of ENMD-2076 to treat HCC, a disease that is difficult to treat. We are finalizing our next steps ENMD-2076 in HCC and / or the fibrolamellar carcinoma, a subset of HCC and for which there is no treatment available and look forward to advancing our global development plan for ENMD-2076 . "
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