Moleculin Shares Update on Investigational New Drug Application

Moleculin Biotech (NASDAQ:MBRX) announced the company completed a request for additional information from US Food and Drug Administration (FDA) regarding their Investigational New Drug (IND) application to study WP1066 as a potential treatment for brain tumors have been submitted.
As quoted in the press release:

Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that responses to FDA requests for additional information relating to the physician-sponsored IND application to study WP1066 as a potential treatment for brain tumors have been submitted.
“We have been working closely with MD Anderson to help them respond to questions from the FDA,” commented Walter Klemp, Chairman and CEO of Moleculin. “A favorable response from the FDA on this request for IND would mean we will have two distinctly different potential cancer drugs in clinic, both Annamycin and WP1066.”
As the Company has disclosed previously, the physician-sponsored IND had been placed on clinical hold pending satisfactory responses to questions provided by the FDA. An MD Anderson physician is planning to conduct a Phase 1 clinical trial to study WP1066 in patients with glioblastoma or melanoma that has metastasized to the brain. Standard FDA procedure is to respond to such IND submissions within 30 days.

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Source: www.marketwired.com