“We are thrilled with the Safety Monitoring Committee advocating that we proceed to the recommended Phase 2 dose level of 60 mg after finding no safety concerns with the 45 mg cohort, which represents important progress in the clinical advancement of SLS009. Based on the encouraging efficacy data and safety profile that continues to emerge in the Phase 2a trial, we remain excited about the potential for SLS009 as a promising treatment option for the many AML patients with poor prognosis and limited alternatives currently available once they become resistant to venetoclax,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer at SELLAS. “To align with the FDA’s Project Optimus initiative, our dosing strategy in this next arm of the Phase 2a trial will include evaluation of two dosing regimens, 60 mg once per week and 30 mg twice per week. We look forward to sharing early data from this cohort as well as further clinical data of the 45 mg cohort around the end of this year or early next year.”
