WntResearch continues to the second dose group in clinical proof of concept study of Foxy-5
WntResearch today announces that the safety evaluation from the first cohort in the dose-finding part of the proof-of-concept study NeoFox, support continued evaluation of the drug candidate Foxy-5 at an additional higher dose. After the most appropriate dose has been defined in the spring, approximately 80 patients with colon cancer will be treated. An initial efficacy analysis is planned based on data from 20 patients in active treatment and 20 patients in the control group.
"We are pleased that patient recruitment to the first dose group in the NeoFox study has been completed so quickly and that our drug candidate Foxy-5 has shown a continued favorable side effect profile. Thus, we are now ready to continue the study by evaluating another higher dose of Foxy-5", says Kicki Johansson, Chief Operating Officer at WntResearch.
The Phase 2 clinical trial NeoFox aims to establish proof of concept for the drug candidate Foxy-5 in the treatment of colon cancer. Patients in the study receive the first treatment with Foxy-5 after diagnosis and are then treated for at least three weeks until the primary tumor is surgically removed. Two higher doses than previously used are now being evaluated, and then the most suitable dose will be used in the treatment of further 80 patients.
WntResearch is planning an initial analysis of the data after 20 patients in the Foxy-5 group and 20 patients in the control group have had their tumor removed. The purpose of this initial analysis is to evaluate the effect of Foxy-5 and at the same time assess whether the planned number of a total of 80 patients is large enough for the study as a whole to demonstrate the desired effect. Final study results are expected in 2025.
The NeoFox study was originally intended to include a two-year follow-up period of the patients. Positive ad hoc observations generated in the study enabled the design to be adjusted, which provides great benefits in terms of time and cost savings. The new study design was approved in the summer of 2023 by the relevant regulatory authorities in Spain.
For further information, please contact:
Pernilla Sandwall, CEOE-mail: pernilla.sandwall@wntresearch.com
About WntResearch
WntResearch is an oncology biotech company that develops new therapies to counteract the development of cancer metastases. The company's research is focused on studying the endogenous protein WNT5A, which has been shown in scientific studies to affect the ability of tumor cells to move and spread in the body. WntResearch's drug candidate Foxy-5 is a peptide that mimics the function of WNT5A with the aim of reducing the mobility and spread of cancer cells and thereby preventing metastases from occurring. Although today's cancer treatment has become more effective, there are no effective ways to prevent the occurrence of metastases that cause about 90 percent of all cancer-related deaths. Foxy-5 has a unique mechanism of action and has shown a good safety profile with few side effects in two clinical phase I studies. The safety and efficacy of Foxy-5 is now being evaluated in the ongoing Phase 2 clinical trial NeoFox in patients with stage II-III colon cancer.
WntResearch's registered office is in Malmö and the company is listed on Spotlight Stock Market. For more information see: www.wntresearch.com