Moleculin Biotech announced the FDA has advised Moleculin it may begin clinical trials of Annamycin in the treatment of relapsed or refractory Acute Myeloid Leukemia.
Moleculin Biotech (NASDAQ:MBRX) announced the US 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).
As quoted in the press release:
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.”