Press release from Companies
Published: 2013-03-25 10:39:50
WntResearch AB (WNT.ST) announces the filing of a Clinical Trial Application (CTA) at the Danish Health and Medicines Authorities (DHMA) for initiation of Phase 1 clinical trial with Foxy-5. The number of patients to be included is unknown since this is a dose escalation study, which primary objective is to evaluate safety and tolerability and to find the recommended dose for Phase 2.
The trial is planned to be carried out at the Oncology Unit at the Herlev University Hospital in Denmark in patients with metastatic breast, colorectal or prostate cancers with no or low level of Wnt-5a expression in the primary tumor. The primary objective is to evaluate safety and tolerability and to find the recommended dose for Phase 2. In addition to this, it is the secondary aim to assess preliminary evidence of anti-metastatic tumor activity. The number of cancer patients to be included in the Phase 1 trial is unknown since the dose escalation will continue until Foxy-5 reaches either a dose limiting toxicity or a dose level equivalent to the level that had an anti-metastatic effect in the pre-clinical studies. CEO Nils Brünner comments: "Today we have filed the Clinical trial Application for the first Phase 1-trial with Foxy-5. This is a huge milestone for WntResearch which has taken its lead product, Foxy-5, all the way from discovery to clinical development. Foxy-5 is for the treatment of metastasis – a feared and lethal condition for cancer patients. We look forward to be able to initiate the study." For further information please contact: Nils Brünner, CEO E-mail: Telephone: +45 2614 4708 About Foxy-5 Foxy-5 has a significant market potential within oncology. Foxy-5 represents a first-in-class concept for the treatment of cancer. The study drug targets the metastatic process which is the primary reason for cancer deaths. Foxy-5 will be one of the first antimetastatic products ever to enter clinical trials. Foxy-5 offers a potential paradigm shift to influnce the treatment of many large cancer indications including breast-, colon and prostate cancer. About WntResearch AB WntResearch (WNT.ST) is a public company listed at AktieTorget. WntResearch is developing novel anti-metastatic therapies for the treatment of cancer patients. The company has filed a Clinical Trial Application for its lead product, Foxy-5, and is aiming at initiating Phase 1 clinical trials in the second quarter 2013.