Pharma Focus America

Biostar Pharma Commences Phase 1 Trial for Utidelone Capsule (Utd2), the World's First Oral Epothilone Anti-cancer Medication

Tuesday, June 13, 2023

Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd., has announced the enrollment of the first patient in a Phase 1 clinical study (BG02-2201; NCT05681000) of their oral formulation product, UTD2 (utidelone capsule), for the treatment of advanced solid tumors in the US. The study will take place at several clinical research centers, including the Sarah Cannon Research Institute, the University of Southern California, and Washington University School of Medicine in St. Louis.

The development of effective and convenient cancer treatments that improve patient compliance is a pressing need. While chemotherapy, particularly microtubule inhibitors, is commonly used, intravenous administration can lead to allergic reactions and inconvenience. Developing oral dosage forms of microtubule inhibitors has proven challenging due to low solubility and resistance to P-glycoprotein. Existing oral taxane formulations have limited bioavailability, and previous attempts have faced safety issues and other obstacles, highlighting the significant unmet medical need in this area.

UTD2, the world's first oral epothilone microtubule inhibitor, aims to address these challenges. Unlike other inhibitors, UTD2 is not a substrate of drug-resistant P-glycoprotein, making it suitable for oral administration. Pre-clinical studies have demonstrated favorable pharmacokinetics, safety profiles, and relatively high bioavailability for UTD2. Unlike injections, utidelone capsules do not require the addition of organic solvents and surfactants, reducing the risk of adverse events and shortening hospital stays. They also offer improved convenience, patient compliance, and the potential for combination therapy with other anti-cancer drugs.

Dr. Li Tang, Chairman of Biostar Pharma, expressed excitement about the first patient enrollment in the US clinical trial, highlighting its importance for the company's international development strategy. The collaboration with renowned US research institutions and investigators demonstrates their dedication to meeting global clinical needs. UTD2 has the potential to revolutionize the administration of microtubule inhibitors, benefiting numerous cancer patients worldwide.

UTD2 is an oral formulation of utidelone (utidelone capsule) developed by Beijing Biostar Pharmaceuticals using their proprietary microbial drug formulation platform. UTD2 is a genetically engineered microtubule inhibitor that has already been approved in China for the treatment of metastatic breast cancer. It is the only newly approved microtubule inhibitor worldwide in the past decade. UTD2 has shown promising features such as efficacy in taxane-resistant patients, low hematological toxicity suitable for long-term use, and the ability to cross the blood-brain barrier to prevent and treat tumor brain metastasis. Phase 3 study results of utidelone injectable have been presented at ASCO annual meetings, published in respected oncology journals, and recommended by the "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer."

The BG02-2201 study, titled "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), is an open-label phase I dose escalation study that will enroll 16-28 patients with advanced solid tumors at multiple clinical research centers in the US. The primary objective is to evaluate the safety and tolerability of UTD2, determine the maximum tolerated dose (MTD), and identify any dose-limiting toxicity (DLT). Secondary objectives include evaluating the pharmacokinetic profile of UTD2 and conducting a preliminary assessment of its anti-tumor efficacy in patients with advanced solid tumors.

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