Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) has marked a significant step in the BEXMAB trial by administering the first dose of bexmarilimab to a patient with myelodysplastic syndrome (MDS) who did not respond to standard hypomethylating agents (HMAs).
MDS is a type of blood cancer where the bone marrow produces poorly functioning blood cells. HMAs, commonly used in treating MDS, work by modifying DNA to promote healthy cell function. However, some patients do not respond to these treatments, presenting a critical need for new therapies.
In its phase II trial, Faron is focusing on patients with HMA-refractory MDS, an aggressive form of myeloid leukemia with limited treatment options.
Researchers are conducting a randomised study with parallel assignment, testing bexmarilimab at two dose levels (3 mg/kg and 6 mg/kg).
This approach is in line with the Food and Drug Administration (FDA)'s Project Optimus, aimed at improving dosing methods in cancer drug development.
Faron's team will compare the safety and efficacy of these doses to determine the most effective for future studies.
Its plan is to discuss a potential registrational study with the FDA after establishing the optimal dosing based on patient responses. This initiative follows encouraging feedback from the recent ASH congress on the potential of bexmarilimab in treating various hematological cancers.
"Dosing of the first patients in this advanced part of the BEXMAB study is another significant milestone in the bexmarilimab programme, and we want to thank our clinical network again for the rapid advancement of our program," said Dr. Birge Berns, Faron's chief medical officer.
"Refractory and relapsed MDS represents a significant therapeutic challenge and based on the recently announced data at ASH from the Phase 1 part of this trial, we believe that bexmarilimab has the potential to save and improve the lives of HMA-failed MDS patients."