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news.Moleculin Biotech has received Fast Track designation from the US Food and Drug Administration (FDA) for WP1122 to treat Glioblastoma Multiforme (GBM), an aggressive malignant primary brain tumour.
Histopathology of high grade astrocytoma features in a glioblastoma. Credit: Mikael Häggström, M.D. / commons.wikimedia.org.
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The designation will potentially facilitate the development and accelerate new therapies review for treating serious conditions which have unmet medical need.
Moleculin noted that the company is now potentially eligible for frequent regulatory meetings as well as communications with the FDA.
Moleculin Biotech chairman and CEO Walter Klemp said: “We believe receiving Fast Track designation validates the serious unmet medical need for the treatment of GBM, the most aggressive form of malignant primary brain cancer.
“We believe that based on the promising animal model data that supports GBM as one of many potential indications, the clearance of our IND for WP1122 in GBM, and Orphan Drug Designation previously received from the FDA, WP1122 is well-positioned to be a potential treatment option for this devastating disease.”
Developed as a 2-DG prodrug to provide favourable pharmacological profile, WP1122 was found to have higher potency than 2-DG alone in preclinical models.
In September this year, WP1122 received Orphan Drug Designation from the FDA for GBM treatment.
Moleculin also obtained clearance of its Investigational New Drug application from the FDA for commencing a Phase I study of WP1122, based on preclinical data which indicated its potential as a treatment for GBM.
The open label, single arm, dose escalation trial has been designed to evaluate the safety, pharmacokinetics and efficacy of oral WP1122 in adult GBM patients.
