Dr. Markku Jalkanen of Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) talked with Proactive about the group’s solid Phase-1 results from the BEXMAB study in myeloid malignancies at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.
The findings, especially in Myelodysplastic Syndrome, show a response rate far exceeding current treatments. Amidst positive investor response, Faron is poised for further trials and partnerships, staying on course for a 2025 marketing approval application.
Thomas Warner (TW): It’s another cheerful day for the business, isn't it? Tell us what you've announced today Mark.
Dr Markku Jalkanen (MJ): “We've been conducting a trial with leukaemia patients, particularly those with a myeloid background. Recently, we've obtained two significant results which we're presenting at the ASH meeting in San Diego, a major event in the American Society of Hematology.
“Our data shows promising responses in certain patient types, specifically those with myeloid differentiation in MDS (Myelodysplastic Syndromes). This is crucial because these patients typically have limited treatment options for this cancer type, and survival rates are often restricted to the first 24 months. We're eager to share more about these encouraging results and their implications.
TW: I am not an expert on myeloid malignancies, or any other malignancies for that matter. But perhaps what's most important is that the investors and the shareholders seem to have responded very positively to the news today.
MJ: “Indeed, even though our trials are in their early stages, we've observed a remarkably high response rate, potentially five to ten times greater than what's typically seen with current standard treatments.
“We're now preparing to advance to the next phase. Following our earlier announcement, we're ready to proceed to the next step. The pivotal pathway involves a limited number of ADCs (Antibody-Drug Conjugates), possibly around 100,000 in Western countries.
“Given the lack of effective treatments currently available for these patients, this represents a significant opportunity for us.”
TW: “What do you think is going to be the next thing that we hear from the market?
MJ: "It’s very interesting on both sides. We are committed to advancing the clinical development process, progressing to phases two and three. Concurrently, we'll seek regulatory feedback and potentially gain additional regulatory advantages based on our data. I'm confident this will enhance our discussions with partners.
“I'm also optimistic that there will be positive news in this regard in the future."
TW: How do you feel about how 2023 has been for the business?
MJ: "The recent developments have been very beneficial for us. We've not only maintained but also increased our pace over the year. This is evident from the accumulating data from ongoing trials, and the initiation of new ones.
“Simultaneously, we're seriously working on building a business around these developments. We aim to reach a point where we can confidently say that we have completed the process up to the marketing approval application. Our target for this achievement is set for 2025, a goal that has remained consistent for some time now. I'm absolutely excited about these prospects."