In an exclusive interview with Thomas Warner from Proactive, Dr Markku Jalkanen, chief executive of Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF), discussed the encouraging results from their ongoing phase I/II trial called BEXMAB.
The study aims to evaluate the efficacy of bexmarilimab in treating acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). The results have exceeded expectations, showing a 50% remission rate among patients who had relapsed or were resistant to standard treatments.
Thomas Warner: You've got a smile on your face there, I can see. And it's all to do with these latest results from your BEXMAB study, isn't it?
Markku Jalkanen: Absolutely, I'm really happy to see the results presented yesterday. They were better than I thought, especially among those really sick people who have no options anymore, and also the leukaemia patients receiving the treatment.
TW: It's a great story. Can you elaborate on how the results matched up to your expectations?
MJ: Well, this has been a dose escalation part of the study. Initially, we didn't know what the optimal dosing would be. As we increased the dosage, we learned that higher doses provide better efficacy and better objective response rates.
Among the seven additional patients we included in this readout, six showed a decline in cancer cells, and five had an objective response. Altogether, we had 22 patients, and 50% showed a decrease in pre-cancer blasts. This is significant because normally, this rate would be less than 10%.
TW: Amazing. What are the implications for the next steps in the market?
MJ: These results support our plan to take the clinical development all the way to marketing approval. We could actually file the PLA (Product Licence Application) in 2025. I'm anticipating that we won't need a massive clinical trial size for this project anymore, probably dealing with 50-100 patients, which is fairly doable.
TW: What can we expect to hear next from the market?
MJ: There are interesting meetings this fall, and perhaps the most interesting one is the American Society of Haematology meeting in early December. We have an accepted poster there, and we can update that prior to the meeting, which we will also inform the markets about.