WntResearch has received approval from the UK authorities for adjusted doses in the Phase 1b study with Foxy-5
WntResearch today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company's proposed changes to the dose levels in the Phase 1b study with Foxy-5 – a potential new drug to inhibit the spreading of tumors. Further, the responsible ethics committee has provided clearance to begin enrollment of patients in the UK. A previously completed Phase 1 study indicates that Foxy-5 has biological activity already at lower dose levels than those originally planned for Phase 1b trial. The adjusted protocol now allows studies of doses in this lower range.
The Phase 1b study will be conducted at study centers in Denmark, the UK and Sweden. Screening for the inclusion of patients has already begun at the study's primary trial centers in Denmark. An opening meeting with the principal investigators in the UK will take place on April 27. WntResearch has applied for corresponding changes in the study protocol also to the Swedish Medical Products Agency.
"The swift approval from the British authorities to start enrollment of patients in the UK is indeed satisfying. The revised study design allows us to obtain biological efficacy data for Foxy-5 at lower doses, which will serve as extremely valuable information for an optimal design of a future Phase 2 trial," says Henrik Lawaetz, CEO of WntResearch.
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 Phase 1b study that has now been approved by both the Danish and UK authorities.
For further information, please contact:
Henrik Lawaetz, CEO
Phone: +46 72 702 4694
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