In an interview with Proactive's Stephen Gunnion, Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF)'s chief executive, Dr Markku Jalkanen, shared promising results from the latest cancer treatment trials.
Faron's innovative approach combines immunotherapy and chemotherapy, showcasing significant advancements in treating acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS), with an astonishing 100% response rate in the MDS group.
Stephen Gunnion (SG): Markku, your team has reported remarkable outcomes in your latest trials, particularly in treating AML and MDS. Could you delve into these findings?
Markku Jalkanen (MJ): Absolutely, Stephen. We've observed significant response rates in patients, especially those with MDS, where we achieved a 100% response rate. This is particularly exciting as many of these patients were previously unresponsive to standard treatments, such as BCL-2 inhibitors and other therapies. Our approach, which combines immunotherapy and chemotherapy, has been effective in eradicating cancer cells and achieving complete remission in patients.
SG: How does the response to your treatment align with your expectations?
MJ: The results have exceeded our expectations. The goal was to eliminate cancer cells from patients, leading to complete remission. Remarkably, we've seen profound changes in patient profiles, with some achieving remission where it wasn't previously possible. This signifies a significant advancement, considering the aggressive nature of myeloid malignancies and their typically short life expectancy.
SG: You mentioned this is part of the second phase of the 'next map' trial. Can you explain the trial's structure and its current phase?
MJ: The 'next map' trial is currently in its second phase, which involves a careful dose escalation process following FDA guidelines. This phase aims to finalize dosing levels this year, paving the way for the pivotal phases and regulatory approval. Our goal is to establish a treatment that significantly outperforms current options for aggressive myeloid malignancies.
SG: Looking ahead, what are the next steps as you seek regulatory approval?
MJ: We plan to submit additional data from 32 patients to finalize the dose levels. This will lead us to the pivotal trial phase. If we continue to see a high response rate, we anticipate moving forward with a regulatory submission. Our hope is to gain FDA approval, potentially offering a new, more effective treatment option for patients with limited alternatives.