The results of phase 1 studies indicate solid safety profile
The Company’s first clinical study demonstrated that Foxy-5 is a drug with a good safety profile. The objective of the trial was to establish a recommended dose for phase 2, but the obtained results did not indicate dose-limiting toxicity for any of the tested dose levels. Foxy-5 exhibited a dose-related pharmacokinetic profile. Furthermore, analysis of tissue samples from two patients in the clinical trial indicated an ability to induce biological activity by means of changes in gene activity.
The phase 1 study was terminated at the highest planned dose without reaching maximum tolerated dose. The reason for this is that Foxy-5 indicated a solid safety profile with few side effects. As a result, a second clinical phase 1b study was conducted to document safety and tolerability of higher doses of Foxy-5 in patients with metastasized cancers that recurred after treatment. The patient group was heterogeneous, consisting of patients with primary tumours in breast tissue, prostate or colon. Foxy-5 exhibited a good safety profile in this study as well, in all of the studied dose groups, which was the primary objective of the study.
Tumour biopsies were performed before and after treatment. As expected, no significant differences in the expression of WNT5A were observed between these times. Changes in non-specific gene expressions were examined in order to determine whether Foxy-5 would cause biological activation. Numerical changes of gene expression were observed on every dose level, both down-regulation and up-regulation. Based on these data and the favourable safety profile of the drug candidate, a dose has been identified for further examination in the now initiated clinical phase 2 trial.