Phase I with WX-UK1
The drug candidate WX-UK1 was studied in different clinical trials with cancer patients. In all trials the compound has been shown to be safe and well-tolerated.
WX-UK1 is an intravenously applied synthetic small molecule inhibitor of uPA and other serine proteases. WX-UK1 acts at multiple points of the metastatic process and specifically inhibits metastasis and tumour invasion.
The compound was designed for the treatment of patients with various solid tumours including breast, gastric, ovarian, colon and pancreatic cancer. In various animal tumour models, WX-UK1 demonstrated potent activity in significantly reducing both primary tumour growth and metastasis formation.
WX-UK1 has successfully completed a Phase Ia study in healthy volunteers. In addition, two European Phase Ib studies with WX-UK1 as a single agent in cancer patients, one study in patients with solid tumours, the other in patients with head & neck cancer, have been successfully completed.
WX-UK1 was also successfully tested in a US Phase I study in combination with the oral chemotherapeutic agent capecitabine. This study was conducted at the Fox Chase Cancer Center, Philadelphia, USA in patients with advanced solid tumours.
The combination therapy with WX-UK1 had a promising outcome in some patients: a longer period of stable disease was noticed. Three patients, two of them with metastatic breast cancer, showed partial responses.
After completion of Phase I trials with WX-UK1 in different indications, the Company decided to conduct further clinical trials of the uPA programme with the oral inhibitor MESUPRON®. The oral application of MESUPRON® offers a significant benefit for the patient.