First patients dosed in a phase 1b trial with Foxy-5 –initial preparations for a phase 2 trial has commenced
The first patients have now been dosed in the phase 1b trial with Foxy-5, a potential new drug to inhibit the spreading of tumors. Preparations are ongoing to expand the trial by adding a study site in Sweden. WntResearch is interacting with the Swedish MPA to facilitate this expansion, and to seek its advice on the design of a phase 2 trial. A recently initiated retrospective tumor sample study will be an important foundation for defining the appropriate sample size and patient categories for this forthcoming trial.
Following the initial screening of patients for the clinical phase 1b trial with Foxy-5, the first patients have now been dosed. All three of the current study sites (Rigshospitalet and Herlev Hospital in Denmark, and Newcastle University Hospital in the UK) are now actively recruiting patients.
Interactions are ongoing with the Swedish Medical Products Agency (MPA), aiming at facilitating an expansion of the phase 1b trial by opening a study site also in Sweden. The trial is expected to be completed during 2016.
Moreover, the Swedish MPA has accepted a request from WntResearch for a Scientific Advice Meeting, to discuss the protocol design of a forthcoming clinical phase 2 trial.
In order to facilitate an optimal design of the forthcoming phase II trial, WntResearch has recently initiated a retrospective study on tumor tissue samples and patient records from 600 patients with stage III colorectal cancer. The results are expected to become available during the fall of 2016. The study results will not only allow statistical power and sample size calculations, but also be decisive for inclusion of colorectal cancer patients (as opposed to just colon cancer patients) in the phase 2 trial.