Press release from Companies
Published: 2016-04-12 08:00:23
WntResearch announced today that the screening of patients prior to enrollment in the Phase Ib study with Foxy-5 has been initiated at the primary trial centers in Denmark. Meanwhile, discussions have been initiated with the regulatory authorities in the United Kingdom and Sweden to explore the possibilities to investigate two lower dose groups than previously planned, focusing on the biological effect. The proposed changes of the trial design are based on results of a previously conducted Phase 1 study, that indicate biological activity of Foxy-5 already at lower dose levels than those initially planned for the Phase 1b study.
In the previously completed Phase 1 study, no dose limiting toxicity for Foxy-5 was observed at any of the eight dose levels tested. A favorable safety profile enhances future possibilities to combine Foxy-5 with other anti-cancer treatments. Tumor samples were successfully obtained pre- and post treatment with Foxy-5 in two of the studied patients. In both these patients, it was noted that certain gene products that are essential for tumor spread were distinctly down-regulated. Although this finding is no ultimate proof of an anti-metastatic effect, it has - together with available toxicological documentation – served as an important base for the suggested adjustment of dose levels in the recently initiated Phase 1b study. "Through this improved design of the Phase 1b study, we see good opportunities to secure more comprehensive biological information on Foxy-5 in the specific dose range that is the likely focus of a future Phase 2 trial," says Henrik Lawaetz, CEO of WntResearch. For practical reasons, the Danish part of the Phase 1b trial will proceed in accordance with the previously approved study protocol, while a parallel inclusion of patients in Sweden and the UK in two lower dose groups presupposes that the authorities will approve the proposed protocol amendments. WntResearch estimates that the changes will not affect the cost or execution time of the phase 1b trial. For further information, please contact: Henrik Lawaetz, CEO About WntResearch WntResearch has entered the clinical development phase with the company's first drug candidate, Foxy-5, which in animal models has been shown to dramatically inhibit the spreading of tumors (metastasis). The company goal is to commercialize new drugs against tumor metastasis. WntResearch is based on research from Professor Tommy Andersson and his research group at Lund University. Their research is aimed at developing innovations based on the protein Wnt-5a and its role in cancer. In addition to Foxy-5, which is in phase 1 clinical development, the company has a preclinical development program - Box-5. In addition to Foxy-5, which is in phase 1 clinical development, the company has a preclinical development program - Box-5. This is a peptide carrying the potential to inhibit metastases in some cancer forms where Foxy-5 is not an adequate treatment. WntResearch AB is a public company listed on AktieTorget. For more information see http://www.wntresearch.com
E-mail: hl@wntresearch.com
Phone: +46 72 702 4694
