On September 13, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some 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 engaged contract research organization ("CRO") Bioscience SA ("Bioscience") to prepare for a proof-of-concept clinical trial in Poland to study its drug candidate WP1220 for the treatment of cutaneous T-cell lymphoma ("CTCL") (Press release, Moleculin, SEP 13, 2017, View Source [SID1234520506]).
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"We believe we are in a position to move quickly to develop WP1220," commented Walter Klemp, Chairman and CEO of Moleculin. "We have a complete IND-enabling data package already, so we should be able to make application soon to the Polish regulatory authorities for a clinical trial authorization. In this case, we believe a proof-of-concept trial in Poland can be completed sooner and for less investment than in the US, giving us a very efficient means to develop yet another asset in our portfolio. As well, success with this trial could help us position WP1220 for accelerated approval in the US."
CTCL is a rare life-threatening skin cancer with limited treatment options. Pre-clinical studies have suggested that some CTCL cell lines may be particularly sensitive to inhibition of the activated form of STAT3, something for which the Company believes WP1220 is especially well suited. The Company’s initial approach will be to administer WP1220 as a topical drug to Stage 1 through 2a patients in an effort to inhibit the progression of the disease.