The United States Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to United States-based Q BioMed Inc's (OTCQB: QBIO) Uttroside-B, a small molecule chemotherapeutic intended for the treatment of hepatocellular carcinoma, it was reported on Wednesday.
The company said that during preclinical studies, the product was up to 10-times more potent against hepatocellular carcinoma cells than Sorafinib. It is likely to benefit from seven-year market exclusivity following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance and tax credits. The company is now conducting preclinical testing to support an FDA Investigational New Drug application (NDA) that is expected this year.
Q BioMed has signed a contract with Rajiv Gandhi Centre for Biotechnology, an autonomous Institute under the Department of Biotechnology, Government of India and the Oklahoma Medical Research Foundation, for the exclusive rights to the technology.
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