Accelerated Clinical Trials Bridging Gateway to Latest Treatments for Cancer Patients - Seite 2

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Biotech, 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.     

Read this and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

Seelos Therapeutics, Inc. (NASDAQ: SEEL) On March 7, the company,  a clinical-stage biopharmaceutical company, announced that it has acquired an exclusive license to intellectual property owned by The Regents of the University of California (The UC Regents) pertaining to a technology that was created by researchers at the University of California, Los Angeles (UCLA). Such technology relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). Seelos plans to study this initial approach in Parkinson's disease (PD) and will further evaluate the potential clinical approach in other disorders affecting the central nervous system (CNS).