Shares of Moleculin Biotech (NASDAQ: MBRX) are trading 7% higher this morning following the company’s news that it has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia (AML). The company expects the FDA will allow the IND to go into effect, which normally occurs within 30 days and would permit Moleculin to begin additional clinical trials of Annamycin. If the IND goes into effect as the company anticipates, it intends to begin clinical trials in the fourth quarter of 2017. “Now that we have all of what the FDA requested, we are pleased to submit a revised IND. We have seen considerable interest from Principle Investigators who are eager to enroll AML patients in an Annamycin clinical trial, so this is a critical step for us,” Moleculin chairman and CEO Walter Klemp stated in the news release.
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About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. The company’s lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. Moleculin also has two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors. For more information about the company, please visit www.moleculin.com.
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