Patient death mars promising MS results in PhII ocrelizumab trial

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 are zeroing in on a market with high unmet medical needs, with analysts forecast MS drug sales are quickly headed to $13 billion. Roche and its partner say they are ready to

"We are strongly encouraged by these data and the possibility that ocrelizumab could become a new option for patients with MS," said Dr. Hal Barron, Roche's chief medical officer. "We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development."

Patient deaths during the Phase III RA trial doomed the program. The two companies shut it down, just as they did for lupus. Ocrelizumab had been one of the brightest starts in Roche's pipeline, but its potential blockbuster status has dimmed considerably in recent months.

- check out the Roche release for more
- read the Reuters story