The European Commission Grants Orphan Drug Designation to Temferon™ for Treatment of Glioma
“European Medicine Agency’s Committee reviewed Genenta’s ODD application for Temferon and agreed on the potential significant benefit that Temferon could contribute to patients suffering from GBM if approved. The ODD designation supports and facilitates the development of our cell therapy-based technology platform for solid tumors,” said Pierluigi Paracchi, Chief Executive Officer at Genenta. “The EMA ODD designation follows the orphan drug designation granted by the US Food and Drug Administration to Temferon for the treatment of GBM in March 2023. The preliminary interim results of Genenta’s ongoing phase 1/2a trials in newly diagnosed patients with unmethylated MGMT gene promoter reviewed by EMA included an Overall Survival at two years, which is longer than the median Overall Survival described in published reports,” continued Pierluigi Paracchi.
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