Moleculin Announces Advancement Of Preclinical Testing For Brain Tumor Drug WP1122

Positive Data Leads to Acceleration of Preclinical Toxicology Testing

HOUSTON, TX - 10/26/16 - Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical and clinical-stage 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, today announced promising initial results of the preclinical toxicology work that has begun for WP1122, a unique inhibitor of glucose metabolism, which is an important driver of glycolytic brain tumor progression and survival.

The Company indicated that preliminary escalating single dose toxicity testing in mice (oral administration) was successfully completed and even at the highest possible dose, no toxic death was observed. In multiple therapeutic doses, WP1122 was well tolerated during intense twice-daily oral dosing. The Company plans to move forward with completing the preclinical toxicology package in order to generate proof of concept in humans.

Moleculin’s Chairman and CEO, Walter Klemp, commented, “As the newest of our technologies, we are pleased to see development work move to the next level. WP1122 has received significant attention from the scientific community as a promising new approach to treating brain tumors. Part of the excitement relates to the unusual nature of WP1122 and its design allowing for high brain uptake and retention. The design uses an alteration similar to that which turns morphine into heroine and enables rapid brain uptake. A similar alteration to our drug allows it to successfully enter the brain in high quantities and increases its circulation time.”

Prior to this announcement, the Company had previously announced the presentation of promising preclinical data in July of this year (Moleculin Announces Data on WP1122 Presented at the 28th Annual International Carbohydrate Symposium), supporting the potential for using WP1122 as a treatment for glioblastoma.

No curative therapy exists for patients with high-grade brain tumors and new approaches to the treatment of this disease are urgently needed. One new approach to tackling this problem has been to focus on shutting down the metabolism of tumor cells, which can be highly dependent on glucose for continued survival and proliferation. WP1122 has been shown both in vitro and in vivo to induce a destruction of glioma cells, the most aggressive form of brain tumor, by essentially “starving” them. Its translational potential as a drug for brain tumors in general and glioma in particular is promising due to its improved circulation time as well as its increased brain uptake.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

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