- Moleculin Biotech (NASDAQ:MBRX) has climbed ~18.1% in the pre-market after announcing that the FDA has approved its request for Fast Track Designation for its experimental drug, Annamycin for the treatment of soft tissue sarcoma (“STS”) lung metastases.
- “We now have potential pathways for accelerated approval in two indications, STS lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia," noted Walter Klemp, Moleculin's CEO.
- “We are now focused on initiating our internally funded clinical trial in the US, possibly prior to mid-year,” Mr. Klemp added.
- STS is the commonest form of sarcoma. An estimated 20% to 50% of STS sarcoma eventually metastasize to the lungs. If tumors cannot be removed surgically, the primary chemotherapy regimen is anthracycline doxorubicin (Adriamycin).
- Annamycin, an anthracycline has been shown to accumulate in the lungs in animal models at up to 30 times the level of doxorubicin.