La Jolla Pharma to proceed with Phase III

Following a meeting with the FDA, LJPC has decided to conduct a Phase III trial of its LJP 394 compound, which binds to double stranded DNA (dsDNA) antibodies, to treat lupus. The decision was made despite results of a previously reported 211-patient North American Phase II/III trial, in which LJP 394 did not confer overall clinical benefit (see BioCentury, Dec. 6, 1999). A Phase III trial, expected to begin in the second half of the year, is based on the finding that a subpopulation of lupus patients have dsDNA antibodies that bind with high affinity to LJP 394. ...