FDA grants orphan drug designation to WP1122 for glioblastoma multiforme
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The FDA granted orphan drug designation to WP1122 for the treatment of glioblastoma multiforme, according to a press release from the agent’s manufacturer.
Glioblastoma multiforme is the most common and most aggressive malignant primary brain tumor. Median survival for patients with the incurable tumor remains only 15 months.
WP1122 (Moleculin Biotech), developed as a 2-deoxyglucose (2-DG) prodrug to confer a more favorable pharmacologic profile, demonstrated greater potency compared with 2-DG alone in preclinical models where tumor cells need more glycolytic activity than normal cells.
Walter Klemp, chairman and CEO of Moleculin, said the orphan drug designation serves as a key milestone in the WP1122 development program.
“Given the progress of our phase 1 clinical trial in healthy volunteers, the strong preclinical data supporting glioblastoma multiforme as one of many potential indications and the recent clearance by the FDA of investigational new drug status for WP1122 in glioblastoma multiforme, we believe this designation further supports the potential of WP1122 and is another step forward in further validating our deep pipeline,” Klemp said in the press release.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation provides Moleculin with various benefits, such as financial incentives for clinical development and — upon regulatory approval — up to 7 years of market exclusivity.
Moleculin also is developing annamycin, a next-generation anthracycline, for treatment of relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases, among other drug candidates for highly resistant viruses and tumors.
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