Moleculin Biotech ((MBRX)) announced an update on their ongoing clinical study.
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Moleculin Biotech is conducting a pivotal Phase 2/3 study titled A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination With Cytarabine Injection Versus Placebo in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed Acute Myeloid Leukemia. The study aims to evaluate the effectiveness of L-Annamycin combined with Cytarabine as a second-line treatment for adults with refractory or relapsed Acute Myeloid Leukemia (AML).
The study tests the drug L-Annamycin, a liposomal formulation, in combination with Cytarabine. This combination is intended to induce remission in AML patients who have not responded to initial treatments.
This interventional study is randomized and uses a factorial intervention model with triple masking (participant, care provider, investigator). The primary purpose is treatment-focused, aiming to determine the efficacy of the drug combination.
The study began on December 5, 2024, with the latest update on October 14, 2025. These dates are crucial as they mark the progress and ongoing status of the trial, which is currently recruiting participants.
The outcome of this study could significantly impact Moleculin Biotech’s stock performance, as positive results may boost investor confidence and position the company competitively within the oncology sector. The study’s progress is being closely watched by investors and industry competitors alike.
The study is ongoing, with further details available on the ClinicalTrials portal.