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Corporate News Blog - Moleculin Biotech to Meet European Medicines Agency; Discussion on Clinical Trial Authorization for the Treatment of Acute Myeloid Leukemia

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LONDON, UK / ACCESSWIRE / August 24, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Moleculin Biotech, Inc. (NASDAQ: MBRX), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=MBRX. The Company announced on August 22, 2017, that it will meet with the European Medicines Agency (EMA) on August 30, 2017, to discuss Clinical Trial Authorization for the study of Annamycin for the treatment of acute myeloid leukemia (AML). For immediate access to our complimentary reports, including today's coverage, register for free now at:


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The EMA is the European equivalent to the US Food and Drug Administration (FDA) and oversees the approval of new drugs for the European Union.

Why the meeting?

Moleculin stated that its planned clinical trial for Annamycin in the US and Poland which may begin shortly, dependent upon the filing and allowance of an IND with the FDA. The Company wants to be in a position to move quickly with Annamycin in the rest of Europe. This meeting will lay the groundwork for expanding Annamycin's market throughout the European Union.

What is Annamycin?

Annamycin is an anthracycline intended for the treatment of relapsed or refractory AML. The predated therapy of combining two chemotherapeutic drugs, which includes an anthracycline, in inducing a remission of leukemic cells (induction therapy) has not improved since it was first used in the 1970s, and as per Moleculin's estimate this induction therapy has the same cure rate of approximately 20% as at that time. Currently, the only viable long-term option for acute leukemia patients is a bone marrow transplant, which is successful in a significant number of patients. However, in order to qualify for a bone marrow transplant, patients have to first undergo induction therapy.

The Rationale for the drug development

Moleculin stated that one of the leading anthracyclines used for induction therapy in acute leukemia patients is doxorubicin. Medicines such as doxorubicin are cardio-toxic, which can result in damage to the heart and limit the dosage amount that may be administered to patients. Additionally, the tumor cells being treated often develop resistance to the first line anthracycline, often through what is called "multidrug resistance" making them capable of purging themselves of the current anthracyclines and limiting the effectiveness of the therapy. Consequently, there remains no effective therapy for these patients.

Annamycin is a unique liposome formulated anthracycline that has been designed to eliminate cardio-toxicity and avoid the multidrug resistance mechanisms that often defeat current anthracyclines. In animal models designed to test for cardio-toxicity, Annamycin has demonstrated to be non-cardio-toxic and in human clinical trials focused on leukemia, it showed fewer dose-limiting toxicities than are normally experienced with doxorubicin.

Annamycin demonstrated efficacy in 8 of 16 patients in a Phase-I study in adult relapsed or refractory AML patients, with 6 of 14 patients completely clearing leukemic blasts. A 30 patient dose-ranging Phase-I/II study in acute lymphocytic leukemia demonstrated a similar efficacy profile, with 3 of 8 patients treated with the maximum tolerable dose clearing their leukemic blasts to a level sufficient to qualify for a bone marrow transplant.

Prospects for Annamycin

Based on initial conversations with the FDA, and because of this serious unmet medical need, Moleculin believes Annamycin may qualify for accelerated approval. The Company also believes Annamycin may qualify for Orphan Drug status, which could entitle the Company to market exclusivity of up to 7 and 10 years from the date of approval of a New Drug Application and Marketing Authorization, in the US and the European Union, respectively.

Last Close Stock Review

On Wednesday, August 23, 2017, the stock closed the trading session flat at $2.42. A total volume of 250.29 thousand shares have exchanged hands. Moleculin Biotech's stock price skyrocketed 20.40% in the last one month, 157.72% in the past three months, and 130.48% in the previous six months. Furthermore, since the start of the year, shares of the Company have gained 6.14%. The stock currently has a market cap of $52.56 million.

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