25 October 2018 , Maastricht, The Netherlands – Cristal Therapeutics, a clinical stage pharmaceutical company developing unique nanomedicines for the treatment of cancer and other diseases, announced today the first patient has been dosed in its Phase 2 clinical trial of lead nanomedicine candidate CPC634 for patients with platinum-resistant ovarian cancer.
CPC634 is a new drug modality. It combines CriPec® nanoparticles with docetaxel (Taxotere®), a clinically validated chemotherapy, as its therapeutic payload. This nanomedicine candidate has been designed to enable enhanced tumour accumulation and localised drug release at the target site, with the goal of boosting therapeutic efficacy. In addition, it is anticipated that CPC634 will overcome the shortfalls associated with current docetaxel products, including toxic systemic side effects.
Dr Joost Holthuis, Cristal Therapeutics’ CEO and co-founder said, “Results from our Phase 1 NAPOLY study demonstrated that CPC634 can be administered safely and was well tolerated by patients with advanced solid tumours. CPC634 also demonstrated encouraging signs of efficacy and reduction in systemic side effects commonly seen with docetaxel.”
Professor Jonathan Ledermann, BSc MD, FRCP, UCL Cancer Institute, London, and Principal Investigator added: “Treatment of platinum-resistant ovarian cancer is an area of high unmet medical need and this trial will give us the opportunity to assess both the therapeutic efficacy of CPC634 and its potential to reduce toxic systemic side-effects such as neutropenia and alopecia, seen with the current standard of care.”
The primary objective of the trial will be to determine the response rate as measured by RECIST, a standard unbiased method for assessing whether a tumour shrinks, stays the same, or gets bigger, with CPC634 monotherapy. The clinical study will be conducted in 10 centres across the UK, Belgium, Netherlands, and Spain.