On August 4, 2023 Vivesto AB, an oncology-focused research and development company, reported early termination of patient enrollment in the Docetaxel micellar advanced prostate cancer Phase 1b study with the Swiss Group for Clinical Cancer Research (SAKK) (Press release, Vivesto, AUG 4, 2023, View Source [SID1234633828]).
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The open-label, multicenter, single-stage Phase 1b study has closed its accrual after enrollment of 11 of the planned 18 patients, since Vivesto believes that the data generated will be sufficient ahead of switching into development with a new formulation based on its improved XR-18 micelle technology platform.
Docetaxel micellar has shown good tolerability at doses considered standard for conventional docetaxel formulations, as well as signs of clinical activity. Docetaxel micellar has been well received by investigators of the SAKK 67/20 and by participating prostate cancer patients.
"We are grateful for the general positive feedback from the principal investigators. Particularly, Docetaxel micellar was safely administered with no infusion reactions and without the requirement for steroid premedication. A thorough analysis of the data, including pharmacological aspects, is pending, and we will await its completion to gain a comprehensive understanding of the outcomes," said Heidi Ramstad, Vivesto’s CMO. "We are grateful to the enrolled patients and for the effort put in by SAKK and investigators in search for better treatment options for prostate cancer."
Vivesto’s Docetaxel micellar is a solvent-free formulation of docetaxel developed to avoid the need for the solubility enhancers in a solvent-based docetaxel and the mandatory high-dose steroid premedication. Patients treated with other existing formulations of docetaxel require steroid administration to avoid certain serious adverse events related to the formulations with solvent. The administration of steroids can lead to marked bone fragility, exacerbated by cancer metastases in the bone, or steroid-related metabolic issues.
Vivesto has progressed in the development of its XR-18 drug delivery platform and intends to use this next-generation improved technology in future development of Docetaxel micellar.