- The FDA has signed off Phase 1b/2 trial for Moleculin Biotech Inc's MBRX Annamycin to treat soft tissue sarcoma lung metastases.
- Annamycin is the company's next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin.
- It has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials to treat acute myeloid leukemia (AML).
- Phase 1b portion of the trial will determine the maximum-tolerated dose and safety of Annamycin, and Phase 2 will explore the efficacy of Annamycin as a single agent.
- A maximum of 25 subjects will be enrolled at the RP2D to evaluate efficacy further.
- The company also expects a second Phase 1b/2 trial of Annamycin in sarcoma lung metastases to be initiated in 2021.
- Price Action: MBRX shares are up 0.69% at $3.64 during the market session on the last check Tuesday.
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