Development of Foxy-5 as a first in class anti-metastatic cancer drug

Purpose and goal

The goal of the project was to bring Foxy-5 into humans as an anti-metastatic anti-cancer compound. It was clear from the original project description, that with the funding and the time frame of the Eurostars grant, we could at best reach initiation of a clinical phase 2 study. Due to the results obtained during the preclinical tox testing and the clinical phase 1 study, we decided to introduce a clinical phase 1b study in order to obtain a better basis for selecting the dose of Foxy-5 to be used in the phase 2 study.

Expected results and effects

We have finalized clinical phase 1 and are ready to initiate clinical phase 1b. We expect that we during 2017 can initiate a pivotal randomized clinical phase 2 study which if successful will allow us to apply the Health Authorities for a conditional approval for Foxy-5 use in cancer patients. Moreover, with such data we will be in a very good position to discuss partnerships with big Pharma.

Planned approach and implementation

The clinical results obtained in WP3 were exceptionally positive in that no dose-limiting toxicity was seen with the planned maximum dosing in humans (patients). Thus, WP7 was redesigned to investigate higher dosages and hence also possibly identifying a dose-limiting toxicity at a higher level. In addition, as originally planned for WP7, the analysis of potential biological surrogate markers would possibly give initial signals of efficacy.