Biostar Pharma Announces First Patient Enrolled for Phase 1 Study of Utidelone Capsule (UTD2)–The World’s First Oral Epothilone Anti-Cancer Drug

Biostar Pharma, the US subsidiary of Beijing Biostar Pharmaceuticals which is a synthetic biology-driven biopharma company focusing on the discovery, development, and commercialization of innovative oncology drugs, is pleased to announce that the first patient has been enrolled today for a Phase 1 clinical study of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule), the world’s first Oral Epothilone Anti-Cancer Drug. 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.

Unmet Medical Need

With the improvement of treatment regimens, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer. However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need.

Advantages of Oral Administration

UTD2 is the world’s first oral epothilone microtubule inhibitor. Utidelone has the advantage of 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.”