(AOF) – TME Pharma announces today that after a complete review of the dossier submitted to it, the American Food and Drug Administration (FDA) has approved the request to launch a new clinical trial (IND – Investigational New Drug Application). ) to evaluate its main active ingredient, Nox-A12, in a phase 2 study in pancreatic cancer (Optimus) in the United States. The biotech specializes in the development of new therapies for the treatment of cancer by targeting the tumor microenvironment (TME).
“The Food and Drug Administration (FDA) approval of our IND application is a defining milestone for TME Pharma, as it represents the first review and approval of Nox-A12 – and more broadly the first review of our unique class of compounds – by the FDA,” comments Aram Mangasarian, CEO of TME Pharma.
“We will now be able to test Nox-A12 in clinical trials in the United States, which represents a major and more than positive step for the future development of Nox-A12”. “We are delivering on our promise to the market to successfully complete Optimus’ launch approval application with the FDA, which will enable rapid resumption of the pancreatic cancer program as soon as funding becomes available.” he concludes.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.