Moleculin Biotech, Inc. (Nasdaq: MBRX) announced the publication of a peer-reviewed cardiac safety analysis of its drug Annamycin in Frontiers in Cardiovascular Medicine. The analysis, titled "Cardiac safety of L-Annamycin: a pooled analysis of five clinical trials," examined data from 90 patients treated across five clinical trials in acute myeloid leukemia (AML) and metastatic soft tissue sarcoma.

The analysis was independently evaluated by a cardio-oncology laboratory at Cleveland Clinic. Researchers found no clinical or subclinical evidence of treatment-related cardiotoxicity, including at cumulative Annamycin doses exceeding traditional lifetime limits for conventional anthracyclines.

Key findings from the pooled analysis included no statistically significant change in mean left ventricular ejection fraction (LVEF), which measured 60.6% at baseline compared with 60.0% following treatment (p=0.84). The analysis found no association between cumulative Annamycin dose and LVEF changes, and no association between patient age and LVEF changes. Serial ECGs, cardiac biomarkers including troponin I/T, and global longitudinal strain assessments showed no evidence of treatment-related cardiotoxicity. Patients received a median cumulative Annamycin dose of 660 mg/m².

Paired echocardiographic data were available for 78 of the 90 patients. The five trials included three in AML and two in metastatic soft tissue sarcoma.

"For decades, the clinical utility of anthracyclines has been limited by cumulative cardiotoxicity and associated lifetime dose limits," said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "The absence of detectable cardiac toxicity in patients receiving cumulative doses of Annamycin beyond those traditional thresholds supports our continued development of Annamycin."

Annamycin is currently being evaluated in Moleculin's MIRACLE clinical trial program for patients with relapsed or refractory AML. The drug uses a liposomal formulation designed to optimize tissue distribution and reduce cardiac exposure.