$MBRX News - Moleculin Biotech Issues Shareholder Update on FDA Designation of Orphan Drug and IND Status for Annamycin

HOUSTON, TX - (http://www.financialnewsmedia.com News Alert) - 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 ("MD Anderson"), today announced that it has issued the following letter to its shareholders.



Dear Moleculin Shareholders, We wish to thank you for your interest and investment in Moleculin Biotech, Inc. This letter is intended to update you on recent and planned activities at Moleculin. As an overview, we recently received Orphan Drug designation from the Food and Drug Administration (FDA) for Annamycin and we continue to make progress toward submitting an IND for Annamycin for the treatment of relapsed or refractory adult AML. As well, the deadline for exercise of short-term warrants connected with our recent offering of common stock has now passed, removing over 5 million shares of overhang from our stock. Read this and more news for Moleculin at: http://www.financialnewsmedia.com/profiles/mbrx.html



PotentialAs we transition from a preclinical to a clinical-stage company, it is important to keep in mind the potential we see for Annamycin. The good news for AML patients currently is that bone marrow transplants are successful in curing AML about 80% of the time. The bad news, however, is that patients must first completely clear their bone marrow blasts (tumor cells) before qualifying for a transplant and the "induction therapy" used to do so only succeeds about 20% of the time. That leaves about 80% of AML patients without hope because there is no approved second-line therapy once the first-line therapy fails.



The magnitude of the unmet need in the treatment of AML is evidenced by the recent purchase of Celator (CPXX) by Jazz Pharmaceuticals (JAZZ). Celator's lead product was a reformulation of the current first-line induction therapy for AML, referred to as "7+3" into a single injectable liposome. This improved delivery method of the same old 7+3 drugs (known as cytarabine and daunorubicin) resulted in an increase in the average overall survival of AML patients by 3.5 months....