WntResearch has included the first patient in the redesign of the proof of concept study NeoFox with the drug candidate Foxy-5
WntResearch announced today that the first patient has been included in the redesign of the Phase 2 clinical trial NeoFox, which is a proof of concept study with the drug candidate Foxy-5. The first patient was recruited at a trial center in Barcelona, Spain.
The Phase 2 clinical trial NeoFox is a proof of concept study in patients with colon cancer which 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 light of the positive safety profile of Foxy-5, the company decided to take advantage of the opportunity to evaluate higher doses than previously used. This is to optimize the possibility of studying the full effect. Thereafter, approximately 80 patients will be treated with the optimal dose.
Patients receive the first treatment of Foxy-5 after diagnosis and are treated for at least three weeks until the primary tumor is surgically removed. The effect is assessed based on local tumour spread and spread to nearby lymphatic vessels, which in turn is expected to reduce the risk of recurrence and distant metastases. The efficacy of the treatment will be evaluated by computed tomography before and after treatment as well as by microscopic examination of surgically removed tumors and lymph nodes.
The clinical study is open-label, randomized, and will compare treatment with Foxy-5 with patients in a control group. Based on the previous patient recruitment rate, results are expected in 2025.
"We have now included the first patient in accordance with the new study design and have achieved an important milestone. In the first phase of the study, we look forward to evaluating which dose of Foxy-5 is optimal to potentially improve the outlook for the patients", says Ramon Salazar, coordinating physician in the study.
"After receiving approval from the relevant authorities for the revised study plan for NeoFox during the summer, we are very enthusiastic that the first patient has now been recruited. The adjusted study plan gives Foxy-5 the best opportunities to show its potential and it also provides great benefits in the form of time and cost savings compared to the original plan", says WntResearch’s CEO Pernilla Sandwall.
For further information, please contact:
Pernilla Sandwall, CEO
E-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