MBRX - FDA grants fast track designation to Moleculin Biotech's treatment for brain cancer

• Moleculin Biotech ( NASDAQ: MBRX ) on Wednesday said it had been granted a fast track designation from the U.S. FDA for its WP1122 treatment for glioblastoma multiforme (GBM), the most aggressive type of brain cancer.
• The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
• "With the Fast Track designation, Moleculin is potentially eligible for more frequent regulatory meetings and communications with the FDA," the company said in a statement .
• MBRX's WP1122 was developed as a 2-DG prodrug. 2-DG, or 2-Deoxyglucose, has been shown to inhibit cancer cell proliferation and is used in the treatment of GBM. According to MBRX, WP1122 was found to have greater potency than 2-DG alone in preclinical models.
• The FDA previously granted an orphan drug designation to WP1122 for the treatment of GBM in Sept. this year. MBRX has also been cleared by the FDA to start a phase 1 study evaluating oral WP1122 in adults with GBM.
• MBRX stock was +3.9% to $1.34 in premarket trading.

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