On September 26, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that the Food and Drug Administration (FDA) has advised Moleculin it may begin clinical trials of Annamycin in the treatment of relapsed or refractory Acute Myeloid Leukemia (AML) (Press release, Moleculin, SEP 26, 2017, View Source [SID1234520635]). The FDA’s determination came after the agency completed its safety review of information and a proposed protocol submitted by Moleculin in an Investigational New Drug application (IND).
“This represents a tremendous milestone for Moleculin,” commented Walter Klemp, Chairman and CEO of Moleculin. “Our primary focus has been to get Annamycin back into the clinic so we can begin optimizing the dosing of the drug as the next step in evaluating its potential to become the first 2nd line therapy suitable for the majority of relapsed or refractory AML patients. It is a thrill to now refer to Moleculin as a ‘clinical stage’ company.”
Dr. Don Picker, Chief Science Officer for Moleculin, added, “We are grateful for the FDA’s thorough and comprehensive review of our IND, and for the manner in which they worked with us to address some key technical issues in the area of Chemistry, Manufacturing and Control.”
Moleculin’s Chief Medical Officer, Dr. Robert Shepard, added: “Responding to comments from the FDA, we have adopted additional patient safeguards that will be implemented while we seek to establish the ‘Recommended Phase 2 Dose.’ This will include reporting interim safety data to FDA before allowing US patients to progress beyond initial agreed-upon dosing limits. After seeing indications of what Annamycin may be capable of from earlier clinical trials, I made it a career goal to get the drug back into the proper clinical trials to determine its potential.”
The US IND going into effect also allows Moleculin to make a submission to Polish authorities necessary for the planned Annamycin clinical trial to also be conducted in Poland.