Patient death mars promising MS results in PhII ocrelizumab trial

Patient deaths during the Phase III RA trial doomed the program.

Just five months after risk factors forced Roche and Biogen Idec to scuttle a program to develop ocrelizumab for rheumatoid arthritis, researchers are touting new mid-stage data showing that MS patients on the drug experienced a reduction in relapses and brain lesions. But they also noted that one person died in the trials and that patients in the drug arm of the trial experienced a higher rate of some side effects than the patients in the placebo arm.

The patient died from systemic inflammatory response syndrome, which is sometimes caused by infection. But the researchers said they could find no evidence of opportunistic infections in the study. Infusion site reactions among patients taking two different doses of the therapy were significantly higher than the placebo group, though researchers reported that the reactions were largely mild to moderate and tapered off during the second infusion.

MS is one of the hottest fields in drug development. Pharma companies