(RTTNews) - Moleculin Biotech Inc. (MBRX) said preliminary interim results from its U.S. Phase 1b/2 clinical trial concluded the safety review of the third cohort and opens the fourth cohort in a dose escalation trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases.
The preliminary data currently demonstrate 50% of patients in first two cohorts experienced clinical activity, defined as stable disease and/or better through 4 months or more of treatment.
The company has now opened enrollment in the fourth cohort of the Phase 1b portion of the study with dosing increased to 390 milligram per square meter. Three subjects minimum (6 maximum) for this and each subsequent dosing cohort will be enrolled until a maximum tolerated dose is identified. Therefore, up to 36 subjects may be enrolled in the Phase 1b portion of the study.
Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of soft tissue sarcoma lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.
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