Date: 2015-03-30
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the annual American Pharmacists Association (APhA) Annual Meeting & Exposition in San Diego, California
Company: Spectrum Pharmaceuticals (USA - NV)
Product: Evomela™ (Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free)
Action
mechanism: alkylating agent. Captisol© is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. Captisol-Enabled, Propylene Glycol-free Melphalan is a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been granted an Orphan Drug Designation by the FDA . This formulation eliminates the use of propylene glycol, which has been reported to cause renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds. The use of the Captisol® technology to reformulate melphalan also improves its stability and is anticipated to allow for slower infusion rates and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity for pre-transplant chemotherapy. Spectrum Pharmaceuticals gained global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals in March 2013. Spectrum assumed the responsibility for the pivotal clinical trial and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On March 30, 2015, Spectrum Pharmaceuticals announced results of a clinical study of the stability of Captisol-enabled Melphalan versus the currently marketed, propylene glycol-containing melphalan formulation entitled, Solution Stability of Captisol-enabled Melphalan vs Marketed Melphalan Products. These results were presented in an oral presentation at the annual American Pharmacists Association (APhA) Annual Meeting & Exposition in San Diego, California (March 27-30 - Abstract #377 Solution Stability Comparison of Capitsol-enabledTM Melphalan HCI vs. Marketed Melphalan HCI Products). Summary: Over time, the rate of degradation for reconstituted solutions of marketed IV melphalan HCl in vials was 17X faster than reconstituted solutions in vials prepared from Evomela™. Similarly, melphalan was shown to degrade 5X faster in infusion bag admixtures prepared from marketed products compared to admixtures prepared from Evomela™. Evomela™ for Injection can be stored up to 1 hour after reconstitution and is stable for an additional 4 hours after preparation of the infusion solution. Data show that Evomela™ has significantly better stability in solution compared to the marketed melphalan formulations. Reconstituted solution in vials is 17X more stable, and the admixture solution in bags is 5X more stable, respectively, than the same solutions prepared using currently marketed formulations.
