Beijing Biostar Pharmaceuticals’ US subsidiary, Biostar Pharma, has enrolled the first patient in a Phase I trial of its proprietary oral formulation of utidelone.
The utidelone capsule (UTD2) is being tested for the treatment of patients with advanced solid tumours.
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The trial will be carried out at various clinical research centres in the US, including the University of Southern California and Washington University School of Medicine in St Louis, Missouri.
It is designed to examine UTD2’s safety and tolerability in advanced solid tumour patients, as well as determine the maximum tolerated dose and dose-limiting toxicity.
The trial’s secondary objectives are to assess the drug’s pharmacokinetic (PK) profile in patients with advanced solid tumours and preliminarily evaluate its anti-tumour activity in these patients through the objective radiologic tumour response using RECIST 1.1.
Other secondary objectives include recommending the dose and dosage regimen for future clinical trials.
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By GlobalDataThe randomised, open-label trial plans to enrol 16 to 28 patients.
UTD2 is claimed to be the world’s first oral epothilone microtubule inhibitor.
According to Biostar Pharma, utidelone can be used as an oral formulation because it is not the substrate of P-glycoprotein.
Various pre-clinical trials of UTD2 showed good PK and safety profiles, as well as relatively high bioavailability.
Biostar Pharma chairman Dr Li Tang said: “The first patient enrolment of UTD2 in the US clinical trial is an important step for our international development strategy.
“We are honoured 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.”
