U.S. Markets closed

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

Research Desk Line-up: AC Immune Post Earnings Coverage

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:

http://protraderdaily.com/register/

Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected AC Immune SA (NASDAQ: ACIU) for due-diligence and potential coverage as the Company announced on August 09, 2017, its financial results for Q2 2017 which ended on June 30, 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on AC Immune when we publish it.

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on MBRX; also brushing on ACIU. Go directly to your stock of interest and access today's free coverage at:

http://protraderdaily.com/optin/?symbol=MBRX

http://protraderdaily.com/optin/?symbol=ACIU

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.

Pro-Trader Daily:

Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charter holder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

NO WARRANTY

PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/.

CONTACT

For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: contact@protraderdaily.com

Phone number: (917) 341.4653

Office Address: Mainzer Landstrasse 50 Frankfurt am Main, Germany 60325

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Pro-Trader Daily