Cristal Therapeutics, a clinical stage biopharmaceutical company developing targeted nanomedicines for the treatment of cancer and other diseases with high unmet patient need, announced today that it has begun a Phase 1b clinical program of its lead nanomedicine candidate CriPec®-docetaxel in patients with solid tumours. This CriPec®-docetaxel program will evaluate the optimal frequency and dosing schedule for Phase 2 clinical efficacy trials, as well as examining the distribution and uptake of this nanomedicine.
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 1b program is being initiated based on preliminary positive Phase 1a 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 1b program is an important milestone, and highlights the unique preliminary safety and pharmacokinetic data produced from the Phase 1a study. We look forward to the results of the consolidated Phase 1 program.”
The Phase 1b 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.