AB Science Shows Promising AB8939 Results in AML Treatment
Update on AB Science's AB8939 and Its Impact on AML
AB Science SA (Euronext - FR0010557264 - AB) is excited to share new developments regarding its innovative microtubule destabilizer, AB8939, particularly its efficacy against acute myeloid leukemia (AML) characterized by MECOM rearrangement.
Clinical Trials Exploring AB8939
AB8939 is currently undergoing evaluation in a phase 1 clinical trial aimed at patients with refractory and relapsed acute myeloid leukemia (AML). This trial, identified as study AB18001 (NCT05211570), seeks to determine the maximum tolerated dose (MTD) of the drug. After successfully completing the initial phase, which involved assessing the MTD over three consecutive days, the trial has progressed to ascertain the MTD over a longer 14-day regimen.
Patient Response and Encouraging Results
Early results from the trial have been promising. Four patients within the study suffering from MECOM rearrangement responded positively to AB8939 as a single agent, demonstrating a striking 50% response rate. Moreover, recent findings show that AB8939, when combined with azacitidine (Vidaza), produces a synergistic effect, suggesting heightened effectiveness against this challenging genetic mutation.
Significance of MECOM in AML
The MECOM gene rearrangement presents a serious challenge, as it exacerbates the aggressiveness of AML and often leads to poor patient outcomes. AB Science's recent findings underscore the potential of AB8939 to counter the negative prognostic implications of MECOM, which affects a notable portion of AML patients.
Future Steps in Drug Development
With the successful demonstration of AB8939's activity against MECOM, discussions with regulatory authorities for a phase 2 clinical trial are anticipated. This trial may permit streamlined pathways toward FDA accelerated approval, particularly beneficial for patients who have limited treatment options. Professor Olivier Hermine highlighted the potential for AB8939 to make a significant impact in this space, especially for patients with high-risk factors.
Patents and Intellectual Property
AB Science is taking progressive steps to protect its innovations, having filed two vital patents concerning AB8939's application in AML and cancers featuring MECOM rearrangement. These protective measures ensure that AB Science can continue its mission in advancing cancer treatments without compromise.
About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia remains a formidable health challenge, with grim statistics indicating that many patients face inadequate treatment or relapse after initial therapy. With an estimated incidence of 100,000 cases in Europe and 60,000 in the USA, the need for effective therapies like AB8939 could not be clearer. Approximately 50% of AML patients do not qualify for stem cell transplantation and are at risk of relapse, further emphasizing the significance of novel treatments.
About AB Science
Founded in 2001, AB Science is dedicated to developing treatments that address significant unmet medical needs, particularly within oncology and other serious health conditions. The company's commitment to innovation has led to a robust portfolio of research and development projects, including its lead compound, masitinib, showcasing their focus on improving patient outcomes worldwide.
Frequently Asked Questions
What is AB8939's role in AML treatment?
AB8939 is a microtubule destabilizer being evaluated as a treatment for AML patients, particularly those with MECOM rearrangement.
What have the preliminary results of the AB8939 trial shown?
Initial results indicate a 50% response rate among patients with MECOM rearrangement when treated with AB8939 as a single agent.
How is AB Science protecting its innovations?
AB Science has filed patents for AB8939, including its use in AML and cancers with MECOM rearrangement.
What does the future look like for AB8939?
The company plans to pursue a phase 2 clinical trial and may discuss accelerated approval options with the FDA.
Why is MECOM rearrangement significant in AML?
MECOM rearrangements indicate a poor prognosis in AML patients, making effective treatments like AB8939 crucial for improving outcomes.
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