US FDA Fast Track designation for NOX-A12 in brain cancer
“At the start of this year, we announced the next phase of our development of NOX-A12 by targeting IND approval and an expedited regulatory pathway in the US and we are very proud to have successfully achieved these milestones within the timeframe we set out,” said Aram Mangasarian, CEO of TME Pharma. “While advancing discussions with potential industrial and financial partners may require some time to materialize, the open IND and Fast Track designation awarded by the FDA are well-received signals by these partners. We now have a clear clinical development roadmap with which to take NOX-A12 forward in the treatment of glioblastoma and to support engagement with potential partners. We expect our new Phase 2 study will build on the unprecedented results of our GLORIA trial, which strengthens the potential of NOX-A12 to become the treatment option of choice for newly diagnosed chemotherapy-resistant glioblastoma. We look forward to working closely with the FDA as we advance NOX-A12 to market as quickly as possible for the benefit of patients suffering from this devastating and aggressive cancer for which there is extremely poor prognosis.”
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