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Moleculin Biotech announced it filed a new drug application for Annamycin treating relapsed or refractory acute myeloid leukemia with the US Food and Drug Administration.
Moleculin Biotech (NASDAQ:MBRX) announced it filed a new drug (IND) application for Annamycin treating relapsed or refractory acute myeloid leukemia with the US Food and Drug Administration.
As quoted in the press release:
Submitting this revised IND marks a significant milestone for Moleculin. FDA allowing the IND to go into effect — which is the anticipated next step and normally would occur within 30 days — will allow the Company to begin additional clinical trials as part of demonstrating the safety and effectiveness of Annamycin. The current plan is to seek approval for treating relapsed or refractory acute myeloid leukemia. If the IND goes into effect as planned, the Company expects to begin clinical trials during the fourth quarter of this year. There can be no assurance, however, that the IND will go into effect within in expected time frame, or at all.
“It took considerable time to produce the additional CMC data requested by the FDA,” commented Walter Klemp, Chairman and CEO of Moleculin, “but 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.”
Click here to read the full press release.
Source: www.marketwired.com