WntResearch continues to the next step in the phase 2 study NeoFox with the highest evaluated dose of Foxy-5
WntResearch announces today that the company, after a very fast patient recruitment, has been able to determine that the highest evaluated dose (8 mg/kg) of the drug candidate Foxy-5 will be used in the next step of the proof of concept study NeoFox. Approximately 80 patients with colon cancer will be treated in the second part of the study and an initial efficacy analysis is planned as early as the end of 2024.
Previously reported ad hoc observations in patients with colon cancer indicate that the company's drug candidate Foxy-5 has a tumor-inhibiting effect already after three weeks of treatment. Based on the positive observations with Foxy-5, as well as the drug candidate's very favorable safety profile, the study plan for the clinical phase 2 study NeoFox has been optimized with the goal of being able to show early effects of Foxy-5. An important part of this work has been the dose-finding stage of the study, which has now been completed after very rapid patient recruitment. The results show that it is safe to proceed with the highest evaluated dose, 8 mg/kg, in the next part of the study. The dose selection has been approved by the study's Safety Committee.
"The ad hoc observations that we have previously learned of are extremely interesting, despite the fact that they are based on a significantly lower dose of our drug candidate Foxy-5 than what has now proven possible to evaluate in the continued part of our phase 2 study. Now we will use higher doses and also give them more often, which means that the patients will be treated with about seven times higher doses per week. I look forward with excitement to the upcoming results from the study", says Christer Nordstedt, Chairman of the Board of WntResearch.
"The announcement from the Safety Committee confirms that our drug candidate Foxy-5 has shown a continued favorable side effect profile at the higher evaluated dose. In addition, recruitment to the two dose-finding cohorts has been faster than expected, indicating a great deal of interest from treating physicians and patients. This bodes well for the continuation of the study and we look forward to the next milestone, which will be an efficacy evaluation when about half of the patients have been recruited to the study," 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 dose of Foxy-5 after diagnosis and are then treated for three weeks until the primary tumor is surgically removed. WntResearch is planning an initial efficacy analysis of the data towards the end of 2024. The purpose of this initial analysis is to evaluate the efficacy of Foxy-5 and at the same time assess whether the planned number of 80 patients is optimal for the study as a whole to demonstrate the desired effect. Final study results are expected in 2025.
For further information, please contact:
Pernilla Sandwall, CEO
E-mail: pernilla.sandwall@wntresearch.com
About Wntresearch AB
WntResearch is developing a completely new type of drug with the potential to improve survival in cancer without giving rise to serious side effects. Ad hoc observations from an ongoing phase 2 study in patients with colon cancer indicate that the Company's drug candidate Foxy-5 has a tumor suppressive effect already after three weeks of treatment. This means that Foxy-5 could counteract the ability of cancer cells to spread and invade healthy tissue, but also potentially eliminate cancer cells. The clinical study is now continuing with the aim of confirming these promising research findings. WntResearch then intends to establish partnerships with one or more international pharmaceutical companies ahead of the final part of the development and a global commercialization. WntResearch's shares are traded on Spotlight Stock Market. For more information, visit www.wntresearch.com