On November 15, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has filed a request with the US Food and Drug Administration (FDA) for a Pre-Investigational New Drug (IND) Meeting to seek FDA’s guidance and concurrence that the WP1732 development plan will meet requirements for an Initial IND filing and initiation of a proposed Phase 1 clinical trial (Press release, Moleculin, NOV 15, 2018, View Source [SID1234531354]).
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"Independent animal model testing has now confirmed high uptake and retention of WP1732 in the pancreas," commented Walter Klemp, Moleculin’s Chairman and CEO. "Taken together with the previous observations of consistent activity against pancreatic cancer in in vitro and in vivo tumor models, this could make WP1732 ideally suited as a new therapy for treating pancreatic cancer. Our request for a Pre-IND Meeting with the FDA represents another important milestone in our effort to begin clinical trials with this promising new drug candidate."