Cristal Therapeutics progresses nanomedicine CriPec-docetaxel to Phase Ib development

This nanomedicine candidate is specifically designed to enable enhanced tumour accumulation and local drug release at the target site, to boost the therapeutic efficacy and to overcome the shortfalls associated with current docetaxel products.

CriPec-docetaxel is a new drug modality that entraps docetaxel (Taxotere), a clinically validated chemotherapy, as its therapeutic payload into nanoparticles. This nanomedicine candidate is specifically designed to enable enhanced tumour accumulation and local drug release at the target site, to boost the therapeutic efficacy and to overcome the shortfalls associated with current docetaxel products, such as the toxic systemic side effects.

The Phase Ib program is being initiated based on preliminary positive Phase Ia results from the open-label, safety and pharmacokinetic study, which suggest that CriPec-docetaxel can be administered at therapeutic dose levels that are safe and well tolerated. CriPec-docetaxel also demonstrated a unique and improved pharmacokinetic profile over Taxotere and other docetaxel-based drug candidates.

Dr Joost Holthuis, Cristal Therapeutics’ CEO and co-founder said: “Progressing CriPec-docetaxel to a Phase Ib program 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 program.”

The Phase Ib study is being conducted at the Department of General Medical Oncology, University Hospitals Leuven, Belgium and at the following three clinical centres across the Netherlands: Erasmus M.C. Cancer Institute, Rotterdam, the Vrije Universiteit Medical Centre, Amsterdam and the University Medical Centre Groningen.