IV Captisol-enabled Melphalan meets safety endpoint

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said IV Captisol-enabled Melphalan met the primary safety endpoint in a Phase IIb trial evaluating the product as myeloablative therapy prior to autologous stem cell transplantation (ASCT) in multiple myeloma (MM) patients. Spectrum declined to disclose details. The open-label, U.S. pivotal trial enrolled 60 MM patients.

Next quarter, Spectrum plans to submit an NDA to FDA for the product, which is melphalan delivered via Captisol sulfobutylether beta-cyclodextrin technology from Ligand Pharmaceuticals Inc. (NASDAQ:LGND). The product is propylene glycol-free. According to Spectrum, propylene glycol is associated with renal and cardiac side effects. ...