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Moleculin Seeks Approval from Polish Regulatory Agency for Skin Cancer Clinical Trial

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Thursday, August 09, 2018

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HOUSTON, TX - 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, announced it has submitted a request to Polish authorities for clinical trial authorization ("CTA") for its STAT3 inhibitor, WP1220, for the treatment of Cutaneous T-Cell Lymphoma ("CTCL").

"This request for CTA, if approved, will give us our third drug in clinic," commented Walter Klemp, Chairman and CEO of Moleculin. "Published research supports the belief that Cutaneous T-Cell Lymphoma, a deadly form of skin cancer, may be highly dependent on the upregulation of the activated form of STAT3. We believe WP1220 may be ideally suited as a topical agent to inhibit STAT3 and therefore could potentially become a valuable new drug for the treatment of CTCL."

A request for CTA in Poland is the equivalent of a request for Investigational New Drug ("IND") status in the U.S. This follows the Company's announcement in June of this year of the approval of a CTA in Poland for its drug Annamycin for the treatment of acute myeloid leukemia ("AML").

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on discoveries made at M.D. Anderson Cancer Center. Our clinical stage drugs are Annamycin, an anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, an immuno-stimulating STAT3 inhibitor targeting primary brain tumors and brain metastases, pancreatic cancer and hematological malignancies. We are also engaged in preclinical development of additional drug candidates, including additional STAT3 inhibitors and compounds targeting the metabolism of tumors.

For more information about the Company, please visit

Joe Dorame, Robert Blum or Joe Diaz
Lytham Partners, LLC

Source: Moleculin Biotech, Inc.
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