Moleculin Biotech (NASDAQ: MBRX) this morning said it has received verbal positive guidance from the FDA regarding the company’s planned IND submission, which could ultimately enable the company to start its next clinical trial earlier than expected. “This new positive guidance removes a major question mark and allows us to create a tighter timeline for the estimated beginning of our next clinical trial. To be clear, we still can’t rule out the possibility of a delay in the timeline, but with the knowledge that the FDA is encouraging us to simply incorporate by reference the prior developer’s IND, we believe we can accelerate our IND submission process. On our current path, we expect to be able to file our IND submission before year end. Barring a negative surprise from the FDA’s review of our submission, that should allow us to begin treating patients in our next clinical trial several months sooner than expected,” Moleculin’s chairman and CEO Walter Klemp stated in the news release. The company has submitted a pre-IND briefing document to the FDA, which recently indicated that it intends to provide written responses to the company by December 6, 2016.
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About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical and clinical-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, a phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. It also has two pre-clinical small molecule portfolios, 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 visit www.moleculin.com
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