Apogenix's asunercept receives PRIME designation for glioblastoma
In late May, Apogenix AG (Heidelberg, Germany) said EMA granted PRIority MEdicines (PRIME) designation to asunercept (APG101, CAN-008) to treat glioblastoma. The designation is based on data from a Phase II trial in which asunercept plus radiotherapy met the primary endpoint of improving the 6-month progression-free survival (PFS) rate vs. radiotherapy alone (20.7% vs. 3.8%, p=0.0485) in patients with relapsed glioblastoma multiforme (GBM) (see BioCentury, March 12, 2012; July 30, 2012 & Feb. 17, 2014).
The compound has Orphan Drug designation in the U.S. and EU to treat GBM, and in the U.S. to treat myelodysplastic syndromes (MDS)...
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