Moleculin Files with FDA for Expedited Approval Pathway for Annamycin

Moleculin Files with FDA for Expedited Approval Pathway for Annamycin

Houston, TX – March 13, 2019 – Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that it has submitted a request for Fast Track Designation with the US Food and Drug Administration (FDA) for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (AML).

 

“Now that we have some traction in our clinical trials of Annamycin for the treatment of relapsed or refractory AML,” commented Walter Klemp, Moleculin’s Chairman and CEO, “we believe it is appropriate to request Fast Track designation for Annamycin.  Importantly, this is a valuable first step in ultimately qualifying for Accelerated Approval and Priority Review.”

 

A drug that receives Fast Track designation is eligible for some or all of the following:

 

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and AML, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin Biotech is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

 

For more information about the Company, please visit http://www.moleculin.com.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to receive Fast Track designation, an accelerated approval pathway or ultimate approval from the FDA for Annamycin. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC.  Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Contacts

Joe Dorame, Robert Blum or Joe Diaz

Lytham Partners, LLC

602-889-9700

mbrx@lythampartners.com

 

Source:  Moleculin Biotech, Inc.

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