The FDA has granted Orphan Drug Designation (ODD) to Kazia Therapeutics’ (NASDAQ:KZIA) paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
Receipt of ODD follows award of Rare Pediatric Disease Designation for DIPG on August 7.
“We look forward to seeing initial data from the ongoing phase I study in DIPG at St Jude Children’s Research Hospital during the second half of calendar 2020,” commented Dr. James Garner, CEO.
Kazia expects to present further data from its ongoing phase II study of paxalisib in glioblastoma at the Society for Neuro-Oncology Annual Meeting in November 2020.
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