Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Dr. Hari (Analyst Day presenter for Evomela) has a new Evomela study (NCT02669615) that started in July. It's a P2 PK study for high dose PG-free melphalan (Evomela). At 1st I thought this was redundant to the 2b study they used for approval but after looking at it a little closer they are giving the high dose 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day -2 whereas the approved label gives 200 mg/m2 of Evomela over 2 days (100 mg/m2 per day). Looks like they are trying to make it more convenient to administer by giving the whole dose in one day. Estimated primary completion date was October but since clinical trials.org is still showing 'recruiting', that date looks like it will be pushed back some (unless they didn't update the record yet). Study completion shows up as March 2017.