Featured Company News – Moleculin Biotech Signs License Agreement with MD Anderson Cancer Center for its Lead Product Candidate, Annamycin

LONDON, UK / ACCESSWIRE / July 20, 2017 / Pro-Trader Daily takes a look 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 Company, which is a preclinical firm focused on the development of anti-cancer drug candidates, announced on July 18, 2017, that it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file related to its drugs Annamycin for the treatment of relapsed or refractory acute myeloid leukemia. The Company’s lead product is Annamycin which is an anthracycline being studied for the treatment of relapsed or refractory 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 Announcement

The Company views this announcement as a step to clear the pending key patent applications, which had yet to be filed, where the signing of a new license agreement with MD Anderson clears the path for those patents. The Company also appointed Theradex Systems, Inc., as its contract research organization for its planned Phase I/II clinical trial for Annamycin, according to Q1 FY17 release, reported on May 15, 2017.

Annamycin

Annamycin is an anthracycline intended for the treatment of relapsed or refractory AML. The therapy is a combination of two chemotherapeutic drugs, of which one is anthracycline. Currently, according to Moleculin, the only viable long-term option for acute leukemia patients is a bone marrow transplant. However, patients, in order to undergo the transplant must undertake induction therapy, which has a cure rate of 20% according to the Company.

Drug Stages

Annamycin demonstrated an efficacy in 8 of the 16 test patients in Phase-I study in adult relapsed or refractory AML patients, with 6 of the 14 patients completely clearing leukemic blasts. Also, for 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.

The Company expects Annamycin to qualify for accelerated approval from the US Food and Drug Administration (FDA), attributing it to the unmet medical need criterion. Also, the Company expects Annamycin to qualify for Orphan Drug Status, which could entitle it to market exclusivity up to 7 and 10 years from the date of approval of a New Drug Application (NDA) and Marketing Authorization in the US and the EU, respectively.

Company Growth Prospects

In Q1 FY17, Moleculin received Orphan Drug Designation by the FDA for Annamycin for the treatment of AML. The Orphan drug status is intended to facilitate drug development for rare diseases and may offer several benefits to drug developers, including tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

Moleculin updated the Annamycin clinical strategy to add a Phase-I arm to its next Phase-II trial that leverages a potential increase in the Maximum Tolerable Dose (MTD), which could increase the chance for positive outcomes. The Company believes that it will be able to publicly announce the results from its Phase-I/II clinical trial sometime in 2018.

Last Close Stock Review

On Wednesday, July 19, 2017, the stock closed the trading session at $1.87, tumbling 8.78% from its previous closing price of $2.05. A total volume of 1.74 million shares has exchanged hands. Moleculin Biotech’s stock price skyrocketed 125.03% in the last one month and 117.44% in the past three months. The stock currently has a market cap of $33.64 million.

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