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Moleculin Announces Updated Preliminary Safety Data for Annamycin in Its Three Phase 1 Clinical Trials for Acute Myeloid Leukemia and Metastases of Soft Tissue Sarcoma
- Review of preliminary interim data continues to demonstrate the absence of cardiotoxicity for Annamycin, representing a significant advancement in patient
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"- Review of preliminary interim data continues to demonstrate the absence of cardiotoxicity for Annamycin, representing a significant advancement in patient safety\n - Preliminary interim data for Annamycin shows a reduced rate of alopecia compared to currently approved anthracyclines\n\n\nHOUSTON, Jan. 18, 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 reported that it has received an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting relapsed or refractory acute myeloid leukemia (AML) and the metastases of soft tissue sarcoma to the lungs (STS Lung), which concluded there was no evidence of cardiotoxicity. The review included analysis of ejection fraction, echo strain and certain troponin levels intended to assess potential for both acute and chronic heart damage. Additionally, the Company reported evidence that Annamycin may have a substantially lower incidence of alopecia (hair loss) than currently prescribed anthracyclines such as doxorubicin. Although 65%-92% of patients treated with doxorubicin typically experience hair loss, the incidence to date in patients treated with Annamycin is less than 10%.[1] Alopecia is considered an important factor in quality of life for many cancer patients.\n\n \n \n \n \n \n \n\n \nTwo of the three clinical trials, as described more fully below, are ongoing and the data from those trials remain preliminary and are subject to change and future updates. The ongoing trials are both in the dose escalation phase (Phase 1) with the goal of determining the recommended Phase 2 dose (RP2D). In the course of this dose escalation, 19 of the 30 patients that have been reviewed to date have now been dosed above the lifetime maximum anthracycline limit currently set by the US Food and Drug Administration (FDA), further underscoring the potential for Annamycin to improve patient safety.\n\"Annamycin was designed to produce little to no cardiotoxicity, so we are pleased to see that this updated report continues to support that objective,\" commented Walter Klemp, Chairman and CEO of Moleculin. \"This is a critical safety impro...