Benzinga | May 25, 2021 11:24AM EDT

Moleculin Biotech to Start Testing Annamycin in Sarcoma Lung Metastases Patients

* The FDA has signed off Phase 1b/2 trial for Moleculin Biotech Inc's (NASDAQ: 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.