Cristal Therapeutics starts clinical phase I trial with nanomedicine CriPec® docetaxel in patients with solid tumours

Maastricht, The Netherlands, September 29, 2015 – Cristal Therapeutics, a privately-held life sciences company developing innovative drugs against cancer and other diseases, today announced the recent start of a clinical phase I trial with its lead candidate CriPec® docetaxel in patients with solid tumours. For this trial, patients are being recruited in two clinical centres in The Netherlands and in Belgium. The first trial data will be available in the course of Q2 2016.

Cristal Therapeutics has developed a pioneering approach to transform existing drugs against cancer, like docetaxel, and other diseases, into tailor-made nanoparticles via its proprietary polymeric technology, registered as CriPec®. The CriPec® platform allows for the rational design of custom-made nanomedicines for controlled release of the drug at the desired site of action resulting in an improved efficacy and tolerability

Lead candidate
CriPec® docetaxel is Cristal Therapeutics’ lead candidate in development and represents a novel treatment approach of solid tumours. CriPec® docetaxel successfully passed various pre-clinical studies, demonstrating a significantly improved safety and tolerability profile. Current docetaxel-containing products often have limited efficacy, and prolongation of survival comes with a high incidence of adverse events. This imposes major limitations on the current therapy. CriPec® nanoparticles accumulate in tumour tissue, resulting in a significantly higher CriPec® docetaxel exposure of the tumour, thereby overcoming drawbacks of conventional docetaxel therapies.

Trial design
The first phase I trial is run by Dr. Ferry Eskens (Erasmus M.C. Cancer Institute (Rotterdam, the Netherlands) and Prof. Dr. Patrick Schöffski (Department of General Medical Oncology, University Hospitals Leuven, Belgium). The safety, tolerability and pharmacokinetics upon different administered doses will be assessed by monitoring adverse events during the study. This phase I study consists of two parts. In part I the recommended dose will be determined. In part II the efficacy and safety will be evaluated of the recommended dose (as determined in part I).

Joost Holthuis, CEO of Cristal Therapeutics says:

“We are very excited about the start of the clinical phase I trial. The outcome of our pre-clinical program has been very encouraging and highlights the clinical potential of CriPec® docetaxel. We are looking forward to advance this compound quickly into the phase I- part II trial that is expected to start next year. If successful, this will enable chemotherapy to be applied more effectively, with fewer adverse events, which is in the interest of patients with solid tumours worldwide.”

Pipeline growth strategy
The start of this clinical phase I trial in is perfect alignment with Cristal Therapeutics’ strategy focused on the further development of candidates in its pipeline. In addition to forwarding its lead candidate, Cristal Therapeutics is also advancing peptide-based product programs (solid tumours), a dexamethasone based product (inflammation) and an antigen nanomedicine based on Cristal Therapeutics’ CriVac vaccine technology.