The Conversation (0)
Moleculin Biotech issued a letter to shareholders updating its FDA designation of an orphan drug and the IND status for Annamycin.
Moleculin Biotech (NASDAQ:MBRX) issued a letter to shareholders updating its FDA designation of an orphan drug and the IND status for Annamycin.
As quoted in the press release:
Progress
The Orphan Drug designation granted to Annamycin as of March of this year for the treatment of AML (Acute Myeloid Leukemia) represents a significant development milestone for Moleculin. The FDA grants Orphan Drug designation to investigational drugs to facilitate drug development for rare diseases, which may provide several benefits to Moleculin, including assistance with clinical study design and drug development, tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity in the US upon regulatory product approval.
We filed our IND (Investigational New Drug) application on February 10, 2017. In subsequent discussions, the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (CMC). We have the additional information, we have made the requested revisions to the protocol, and we are developing the CMC data. In the interim, we withdrew the IND application so that we may resubmit it when the requested data becomes available. We are working to resubmit the IND application in time for the IND to go into effect and to announce that we may begin Phase I/II clinical trials by the end of July of 2017. However, if we are unable to obtain the required CMC data on a timely basis, we will be delayed in resubmitting our IND application, which will delay the commencement of our clinical trials.
Click here to read the full press release.
Source: www.marketwired.com