Corporate News Blog – FDA Grants Approval to Moleculin Biotech for Clinical Trials of Annamycin in the Treatment of AML

LONDON, UK / ACCESSWIRE / September 28, 2017 / Pro-Trader Daily looks at the latest corporate events and news making the headlines for Moleculin Biotech, Inc. (NASDAQ: MBRX) (“Moleculin”), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=MBRX. The Houston based preclinical and clinical-stage pharmaceutical Company announced on September 26, 2017, that it has received approval from the Food and Drug Administration (FDA) to start clinical trials of Annamycin in the treatment of relapsed or refractory Acute Myeloid Leukemia (AML). The approval was granted after FDA completed its safety review of information and a proposed protocol submitted by Moleculin in an Investigational New Drug application (IND). For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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The US IND also allowed Moleculin to make a submission to Polish authorities for the planned Annamycin clinical trial to be conducted in Poland.

FDA Approval Represents a Tremendous Milestone for Moleculin

Walter Klemp, Chairman and CEO of Moleculin, stated that this represents a tremendous milestone for Moleculin. The Company’s primary focus has been to get Annamycin back into the clinic so it can begin optimizing the dosing of the drug as the next step in evaluating its potential to become the first 2nd line therapy suitable for the majority of relapsed or refractory AML patients.

Moleculin Adopted Additional Patient Safeguards to be Implemented while Establishing Recommended Phase-2 Dose

Dr. Robert Shepard, Moleculin’s Chief Medical Officer, mentioned that the Company has adopted additional patient safeguards that will be implemented while it seeks to establish the Recommended Phase-2 Dose. This will include reporting interim safety data to FDA before allowing US patients to progress beyond initial agreed-upon dosing limits. Dr. Robert added that after seeing indications of what Annamycin may be capable of from earlier clinical trials, he made it a career goal to get the drug back into the proper clinical trials to determine its potential.

Moleculin Filed IND with FDA for Annamycin in August 2017

News release suggests that on August 08, 2017, Moleculin filed with the FDA an Investigational New Drug application to study Annamycin in the treatment of relapsed or refractory AML. The purpose of the filing was to seek approval for treating AML.

Moleculin previously filed an IND, in response to which the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing, and Controls (CMC). The Company withdrew its original application to incorporate the request, with the goal of resubmitting the application when that was accomplished.

About Annamycin

Annamycin is an anthracycline antibiotic intended for the treatment of relapsed or refractory AML. Annamycin is classified as a member of the anthracycline family and has been engineered to be non-cardiotoxic and invisible to the body’s natural defense mechanisms. The drug is Moleculin’s lead product candidate. In the two most recent trials, Annamycin was able to generate significant activity with acute leukemia patients who would be considered part of the unlucky 80% or labeled as untreatable.

About Moleculin Biotech Inc.

Founded in 2015, Moleculin Biotech, Inc. is focused on the development of game-changing anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center, the world’s largest cancer research facility.

Last Close Stock Review

On Wednesday, September 27, 2017, the stock closed the trading session at $2.50, declining 6.02% from its previous closing price of $2.66. A total volume of 989.40 thousand shares have exchanged hands. Moleculin Biotech’s stock price skyrocketed 6.84% in the last one month and 125.20% in the previous six months. Furthermore, since the start of the year, shares of the Company have surged 9.65%. The stock currently has a market cap of $51.10 million.

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