Medarex Files INDs With FDA

Medarex has submitted two investigational new drug applications (INDs) to the FDA for MDX-1342.

One application is for the treatment of chronic lymphocytic leukemia (CLL) and the other is for rheumatoid arthritis, Medarex said.

The CLL application is for an open-label, multidose, dose-escalation Phase I trial that is expected to enroll up to 52 patients.

The rheumatoid arthritis application is for a randomized, single-dose, dose-escalation, placebo-controlled Phase I trial that is expected to enroll up to 90 patients.