Netherlands-based Cristal Therapeutics has launched a Phase Ib clinical programme to assess its nanomedicine candidate CriPec-docetaxel for the treatment of solid tumours.
CriPec-docetaxel is being developed as a new drug modality to entrap a clinically validated chemotherapy, docetaxel (Taxotere), as therapeutic payload into nanoparticles.
Designed to allow increased tumour accumulation and local release of the drug, the candidate is intended to enhance therapeutic efficacy and overcome challenges such as toxic systemic side-effects associated with existing docetaxel products.
In addition to evaluation of the distribution and uptake of the nanomedicine candidate, Phase Ib programme will determine an optimal frequency and dosing schedule for Phase II clinical efficacy trials.
Cristal Therapeutics CEO and co-founder Dr Joost Holthuis said: "Progressing CriPec-docetaxel to a Phase Ib programme is an important milestone, and highlights the unique preliminary safety and pharmacokinetic data produced from the Phase Ia study.
"We look forward to the results of the consolidated Phase I programme."
The preliminary positive data obtained from the open-label, safety and pharmacokinetic Phase Ia trial indicated favourable safety and tolerability of the nanomedicine.
Furthermore, the results revealed that CriPec-docetaxel could be given at therapeutic dose levels.
In addition, the nanomedicine candidate is reported to have shown improved pharmacokinetic profile, when compared with other docetaxel-based drug products such as Taxotere.
The Phase 1b programme is being performed at three clinical sites across the Netherlands and at the University Hospitals Leuven General Medical Oncology department in Belgium.