LONDON, UK / ACCESSWIRE / October 5, 2017 / Pro-Trader Daily looks 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 October 03, 2017, that it has entered into an agreement with a Poland-based hospital to conduct clinical trials for evaluating the efficacy of its lead product candidate Annamycin in treating acute myeloid leukemia (AML). This is the first of several hospitals desiring to be treatment centers for the trial. For immediate access to our complimentary reports, including today’s coverage, register for free now at:
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FDA Approval for Clinical Trials for Annamycin
Moleculin declared that the Food and Drug Administration (FDA) has allowed it to begin clinical trials of Annamycin for the treatment of relapsed or refractory Acute Myeloid Leukemia on September 26, 2017. The FDA approval came after the agency concluded its safety review of information and a proposed protocol submitted by Moleculin in an Investigational New Drug (IND) application.
Walter Klemp, Chairman and CEO of Moleculin shared his views about the approval. He disclosed that this is a significant milestone for Moleculin, whose main focus has been to get Annamycin back into the clinic so that it can commence optimizing the dosing of the drug. This is the follow-up step for assessing Annamycin’s potential for becoming the first 2nd line therapy suitable for relapsed or refractory AML patients. He was thrilled that one could now refer to Moleculin as a ‘clinical-stage’ Company.
Moleculin’s Lookout for Treatment Sites
Walter Klemp stated that since FDA has approved their investigational new drug application, Moleculin is now commencing the process of opening treatment centers and recruiting patients. He revealed that the Company has identified around 14 sites that meet the criteria. In fact, some of these sites have already expressed an interest in participating. Thus, the Company would enter into agreements with a lot more treatment centers in the near future.
First Facility for Clinical Trial in Poland
The first facility selected for the Clinical trial of Annamycin is a hematology clinic in a major hospital in Poznan, Poland. Moleculin entered into this first agreement with the Hospital of the Transfiguration of the Lord – Medical University in Poznan, Department of Hematology and Marrow Transplantation. However, to treat patients in this hospital or any other site in Poland, Moleculin would need a separate regulatory approval in Poland based on the approved US IND.
Walter Klemp highlighted that the process is Poland is somewhat different from that in the US. That is how Moleculin was able to get the Poland site signed up soon after receiving the approval from FDA. The Company intends to make similar announcements for additional sites in the coming months. In fact, it plans to get a total of seven treatment sites in Poland itself.
About Moleculin Biotech, Inc.
Moleculin Biotech is a clinical-stage pharmaceutical Company that works towards the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Its lead product Annamycin is being evaluated for the treatment of relapsed or refractory acute myeloid leukemia. The Company also has two preclinical small molecule portfolios in development, one of which is concentrated on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.
Last Close Stock Review
At the closing bell, on Wednesday, October 04, 2017, Moleculin Biotech’s stock dropped 2.41%, ending the trading session at $2.43. A total volume of 364.28 thousand shares have exchanged hands. The Company’s stock price skyrocketed 48.17% in the last three months and 147.96% in the past six months. Moreover, the stock gained 6.58% since the start of the year. The stock currently has a market cap of $51.35 million.
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