FDA clears IND application for NOX-A12 Ph 2 trial in brain cancer

“Receiving approval of the FDA for the design of our Phase 2 clinical trial in glioblastoma provides a clear roadmap to potential industrial partners and investors on the next steps in clinical development. The discussions with the FDA have been constructive and have allowed us to design a robust Phase 2 that should provide us with solid evidence of the highly differentiated profile of NOX-A12 in combination with bevacizumab in newly diagnosed, chemotherapy-resistant glioblastoma patients. The open IND will also allow us to expand our clinical development into the US, where we expect to generate significant interest in the medical community,” said Aram Mangasarian, CEO of TME Pharma. “We also expect to receive the FDA’s decision regarding Fast-Track Designation for NOX-A12 in glioblastoma in the next few weeks, which can further strengthen our regulatory position in the US and should help us in the search for industrial and financial partners who can assist TME Pharma in bringing NOX-A12 to patients in the quickest way possible.”