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
"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
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.
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E-mail: pernilla.sandwall@wntresearch.com
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