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Moleculin Reports 80% Overall Response Rate in Final Cohort of Phase 1 Single Agent Trial of Annamycin for the Treatment of Acute Myeloid Leukemia (AML)
Preliminary efficacy updated to 80% overall response rate (ORR) demonstrated in single agent AML trial following database lock Next generation anthracycline,
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"Preliminary efficacy updated to 80% overall response rate (ORR) demonstrated in single agent AML trial following database lock \nNext generation anthracycline, Annamycin, has demonstrated both safety and promising early activity across multiple clinical studies with potential to be an effective treatment across multiple oncology indications\nRecent independent report from cardiology expert concluded Annamycin has no evidence of cardiotoxicity to date in a total of 42 subjects across three of the Company's Annamycin clinical trials \nGranted FDA Fast Track and Orphan Drug designation for AML and STS lung mets \nHOUSTON, Dec. 15, 2022 /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 provided an update on its clinical programs evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. These updates were recently presented during a reception for potential investigators held outside of the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.\n\n \n \n \n \n \n \n\n \nKey updates made during the presentation were as follows:\nAnnounced 80% overall response rate (ORR) in final cohort (n=5) of the European trial of Annamycin as a single agent for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) with one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response).Of a total of 42 subjects in three of the Company's Annamycin clinical trials, 100% demonstrated no signs of cardiotoxicity as confirmed by independent expert. All expert reviews included analysis of ejection fraction, echo strain and certain troponin levels intended to assess the potential for both acute and chronic heart damage. In two of the Company's Annamycin clinical trials, 32 subjects have been, as allowed by the trial protocol, safely treated above the current FDA lifetime maximum anthracycline dose (550 mg/m2) with up to 1800 mg/m2 of Annamycin treatment with no evidence of cardiotoxicity as confirmed by an independent expert.Data so far have resulted from treatment with Annamycin as a single agent, however, based on additiona...