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Moleculin Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases
HOUSTON, Dec. 17, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"\n \n HOUSTON, Dec. 17, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) is allowing the company's Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect. This allows Moleculin to begin a Phase 1B/2 clinical trial in the US for patients with soft tissue sarcoma that has metastasized to the lungs after first-line therapy for their disease. \n\n \n \n \n \n \n \n\n \nIt is estimated that there are approximately 36,000 new cases of soft tissue sarcoma (STS) in the 7 major markets (US, EU5 and Japan) each year, and an estimated annual market size of over $177 million for the treatment of STS lung metastases. Our clinical advisors estimate that approximately half of all STS patients will eventually develop lung metastases from their primary tumor. Although first-line treatments such as surgical resection, chemotherapy and radiation may provide initial therapeutic benefit for an estimated 35% of those patients, there are no approved or emerging second-line therapies for the remaining 65% who relapse or are refractory. Although the lungs tend to be a major site of relapse, we are aware of only 2 active clinical trials specifically targeting STS lung metastases, indicating that Annamycin faces limited competition in this area of development.\nMoleculin recently announced that Annamycin demonstrates consistently high antitumor activity in vivo in all tested animal models of different types of lung-localized cancers, including sarcoma. These promising findings correlate with surprisingly high uptake of Annamycin to the lungs in animal models. This uptake is up to 34-fold higher than that of doxorubicin, the primary first-line chemotherapy for STS. The limited pulmonary uptake of doxorubicin in animal models may help explain its lack of activity against STS lung metastases in humans. Additionally, clinical data show no cardiotoxicity associated with the use of Annamycin, as well as the ability to avoid multidrug resistance mechanisms, both of which are often treatment-limiting effects of anthracyclines (which includes doxorubicin) ...