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Moleculin Receives FDA Approval of Fast Track Designation for Annamycin
HOUSTON, April 18, 2019 /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":"HOUSTON, April 18, 2019 /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, today announced that the U.S. Food and Drug Administration (\"FDA\") has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (\"AML\"). \n\n \n\"We are thrilled that Annamycin has been granted Fast Track Designation,\" commented Walter Klemp, Moleculin's Chairman and CEO. \"Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of the significant unmet need we are trying to address. Currently, Annamycin is in separate Phase I/II trials in the U.S. and Europe for the treatment of AML and the Company has recently announced positive interim top line data.\" \nA drug that receives Fast Track designation is eligible for some or all of the following:\nMore frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDAAbout Moleculin Biotech, Inc.\nMoleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company's clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT...