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Moleculin Biotech (NASDAQ: MBRX) to Begin Preparing Clinical Testing Sites for Leukemia Treatment

  • NASDAQ Biotechnology Index up and climbing
  • Developing new treatment for acute myeloid leukemia (AML)
  • Lead candidate, Annamycin, now at phase II

Since a rising sea lifts all boats, it’s decidedly good news for Moleculin Biotech, Inc. (NASDAQ: MBRX) that the NASDAQ Biotechnology Index (NBI) is enjoying a spring tide. The index has offered a year-to-date return of over 17 percent and seems set to keep climbing. This benign environment gives Moleculin an opportunity to advance work on its leading anti-cancer drug candidates. The company has begun to identify and prepare testing sites in Europe and has already appointed a Lead European Principal Investigator.

Moleculin was featured on Business Insider (, in a piece that attributed the rise in the NBI to ‘recent FDA decisions and clinical trial developments’. Moleculin, a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, announced on August 3 that it had selected Bioscience SA (Bioscience), a Polish contract research organization (CRO) to begin identifying and preparing clinical testing sites in Poland for Annamycin. Annamycin is the company’s drug candidate for the treatment of relapsed or refractory acute myeloid leukemia (AML).

AML is a type of blood cancer that usually develops in cells destined to become leukocytes or immune cells. It stunts their development and, consequently, results in a profusion of immature cells. As these immature cells, also known as blast cells, continue to build up, they may find their way into the lymph nodes, the liver, the spleen, the testicles or the brain, with highly deleterious effect.

In 2016, about 21,380 people of all ages (11,960 men and boys and 9,420 women and girls) were diagnosed with AML in the United States, according to Cancer Net ( The condition is the second most common type of leukemia diagnosed in adults and children. It is rare for AML to occur before age 45, and the average age at the time of diagnosis is 67 years. However, roughly three-quarters of those who develop it die within five years.

Moleculin’s lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory AML. So far, there are promising indications that Annamycin can circumvent some of the problems encountered in current treatment regimens, such as the risk of cardiotoxity, where treatment drugs damage the heart, and multi-drug resistance. Moleculin also has two active pre-clinical small molecule candidates in the pipeline. The first is directed at modulating hard-to-target cell signaling mechanisms and appears capable of stimulating a patient’s natural immune system while also attacking tumors directly. The second candidate targets the metabolism of tumors and exploits a unique approach for crossing the blood brain barrier for the treatment of glioblastoma and other central nervous system malignancies.

Some of Moleculin’s anti-cancer drug candidates are based on license agreements with The University of Texas System on behalf of the MD Anderson Center. MD Anderson is one of the original three comprehensive cancer centers in the U.S., and, in 2016, was ‘ranked #1 for cancer care in the “Best Hospitals” report published by the U.S. News & World Report.’

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