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news.Sosei Co and Xenova's SOT-107 has been granted orphan drug status for the treatment of glioma, a type of brain tumor, by Japan's Ministry of Health, Labour and Welfare. Xenova shares grew by more than 11% in pre-market trading following the news.
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SOT-107, licensed from Xenova Group, is being developed by Sosei initially for the recurrent form of this brain tumor. The medical need for improved treatment of this disease is high as survival rates for patients suffering from glioma are low.
Orphan drug designation will facilitate Sosei’s initiation of clinical trials and provide a fast track approval process by the MHLW once trials have been completed.
Mr Shinichi Tamura, president & CEO of Sosei, commented: “This orphan drug status is a significant step for the development and commercialization of SOT-107 in Japan and we will do our best to bring this product to patients as soon as possible.”
SOT- 107 is a novel product, developed as TransMID in the EU/US. It is based on the transferrin-mediated delivery of a modified diphtheria toxin, which is capable of selectively killing cancer cells.
A completed phase II study conducted in a number of leading centers in the US showed highly promising clinical response rates and an improvement in median survival times in patients with recurrent brain tumor, from a historical average of 26 weeks up to 37 weeks.
The FDA granted TransMID fast track status in August 2001 and orphan drug status for the treatment of malignant tumors of the central nervous system in December 2001. The European Medicines Agency’s Committee for Orphan Medicinal Products granted orphan designation for the treatment of glioma in March 2002.