CYT107 gets orphan drug status in Europe - treatment of PML
Posted: Tue Aug 07, 2012 12:43 am
Cytheris SA, a privately held clinical-stage biopharmaceutical company focused on treating lymphopenia driven diseases, announced that the European Commission has granted an orphan designation for Cytheris' CYT017, glycosylated recombinant human interleukin-7 (glycosylated r-h-IL7), for the treatment of Progressive Multifocal Leukoencephalopathy (PML).
Additionally, Cytheris obtained scientific advice for a phase IIb study protocol with CYT107 in HIV-related PML. Cytheris has reached an agreement with the EMA on the key study endpoints. Cytheris will start this phase IIb study, intended to be pivotal, in early 2013.
PML is a severe demyelinating disease of the central nervous system caused by the JC virus. It occurs in many conditions leading to severe lymphopenia such as HIV infection, some cancers and organ transplantation treated with immunosuppressive therapies. PML is a very rare disease, affecting around four out of a million individuals. There is currently no marketed drug for the treatment of this devastating condition.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/3406