Biostar announces first patient enrolled for Phase 1 study of Utidelone Capsule
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Biostar announces first patient enrolled for Phase 1 study of Utidelone Capsule

UTD2 is the world's first oral epothilone microtubule inhibitor

  • By IPP Bureau | June 13, 2023

Biostar Pharma, the US subsidiary of Beijing Biostar Pharmaceuticals, has announced that the first patient has been enrolled for a Phase 1 clinical study of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US.

This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al.

UTD2 is the world's first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it's not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability.

Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs.

Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world."

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