Development
DEVELOPMENT STATUS
NormOxys has identified the lead candidate, OXY111A, and has developed manufacturing processes that meet Good Manufacturing Practice (GMP) regulations for both the active pharmaceutical ingredient (API) and for final drug product. Clinical supplies of API and drug product have been successfully produced.
The IND-enabling studies for the first-in-human clinical trial were completed with no major toxicology or safety pharmacology findings. The initial IND was filed with the Division of Oncology Drug Products at FDA in late 2009, and was approved in January 2010.
A Phase I single ascending dose study in normal healthy volunteers is currently ongoing.