Sosei Co. Ltd, Xenova Group's licensee for the Japanese market, has been granted orphan drug status for the use of TransMID in the treatment of glioma (a type of brain cancer) by the ministry of health, labour and welfare (MHLW) in Japan.
TransMID is Xenova's lead product candidate currently in Phase III trials for the treatment of glioblastoma multiforme. The achievement of orphan drug designation triggers a milestone payment from Sosei to Xenova, the company statement said.
Orphan drug designation will facilitate the initiation of clinical trials by Sosei and provide fast track approval process by the MHLW once trials have been completed and a dossier seeking marketing approval has been filed.
David Oxlade, CEO of Xenova said: "TransMID has already demonstrated significant improvement over existing treatments in Phase II clinical trials increasing median survival for patients from a historical average of 26 weeks up to 37 weeks. The positive response from the MHLW in Japan, following that from the FDA and the EMEA, underlines the potential for TransMID in the worldwide market for brain tumour treatment."