Closely-held NOXXON Pharma said one of its Spiegelmer therapeutics, olaptesed pegol (NOX-A12), received orphan drug designation from the FDA for the treatment of glioblastoma in conjunction with radiotherapy.
Currently, olaptesed pegol is under investigation in Phase 2a studies in two hematological cancers: multiple myeloma and chronic lymphocytic leukemia. Orphan drug designation will support NOXXON’s further development of olaptesed pegol for the treatment of glioblastoma.
In a statement, CMO Dr. Matthias Baumann said orphan drug designation for olaptesed pegol in the U.S. is a significant regulatory milestone for NOXXON.
“In conjunction with interim results of our ongoing Phase 2a studies in multiple myeloma and chronic lymphocytic leukemia, the preclinical glioblastoma findings further support the broad therapeutic potential of olaptesed pegol,” he added.
Glioblastoma is the most common and most aggressive primary malignant brain tumor, associated with poor outcomes and low survival times.
