October 15, 2010 / 6:24 PM / 9 years ago

UPDATE 1-Roche, Biogen report one death in MS drug trial

* Data reported at ECTRIMS meeting on Friday

* Efficacy based on lesions, relapse rate, significant

* Side effects include infusion reactions, inflammation

By Toni Clarke

BOSTON, Oct 15 (Reuters) - Roche Holding AG ROG.VX and Biogen Idec Inc (BIIB.O) reported data from a mid-stage trial of their experimental multiple sclerosis drug ocrelizumab on Friday that showed one patient died of an inflammatory condition.

Data presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showed that the drug reduced disease activity by a significant amount as measured by the number of brain lesions and relapse rate. But some side effects were greater in the ocrelizumab arm than in the placebo arm.

In May, Roche of Switzerland and Biogen of Cambridge, Massachusetts, said they would discontinue studies of the drug as a treatment for rheumatoid arthritis after a safety monitoring board ruled that the risk outweighed the benefit in the RA population.

The decision followed reports of serious infections, some of which were fatal, as well as opportunistic infections — or infections that do not normally occur in healthy people.

The companies said that in the latest 220-patient MS trial no opportunistic infections were reported, and they said no causal link had been established between ocrelizumab and the patient death from systemic inflammatory response syndrome (SIRS). Roche said exhaustive analysis showed the condition in this case was not sparked by an infection, even though it sometimes can be.

There were no cases of SIRS in the placebo group or among patients who received the lower of the two doses of ocrelizumab. However, 1.8 percent of patients — or one out of 55 — who took the higher dose developed the condition.

Infusion-site reactions such as swelling were higher in the ocrelizumab group than in the placebo group — with 34.5 percent of those taking the lower dose and 43.6 percent taking the higher dose experiencing a reaction compared with 9.3 percent in the placebo group. The reactions were in general mild to moderate, the companies said, and the reports decreased during the second infusion.

In general, the companies said, the serious side effect profile was similar in all treatment groups, with the drug showing strong efficacy.

The total number of brain lesions detected by magnetic resonance imaging (MRI) in the study was reduced by 96 percent in the higher-dose group and 89 percent in the lower-dose group compared with placebo.

“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, chief medical officer at Roche. “We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development.”

Patients will be treated for up to 96 weeks, receiving ocrelizumab infusions every 24 weeks.

Multiple Sclerosis is an autoimmune disease in which a patient’s immune system attacks their body, causing damage to the protective sheath surrounding nerves in the brain and spinal cord and leading to such symptoms as impaired mobility, fatigue, cognitive, speech and other difficulties.

It is a large and increasingly competitive market. Rival Genzyme Corp GENZ.O, which is developing an MS drug called alemtuzumab, estimates the market will soon be worth around $13 billion. On Thursday it showed that after five years its drug’s efficacy remained strong, with no new or worsening side effects. [ID:nN13242220]

French drugmaker Sanofi-Aventis (SASY.PA), which is locked in a battle to buy Genzyme, said on Friday that its own experimental MS drug, teriflunomide, significantly cut relapses in patients who took the once-daily oral treatment. [ID:nLDE69DOX1]

Swiss drugmaker Novartis NOVN.VX became the first to bring an oral multiple sclerosis drug to the market, winning U.S. approval for its drug Gilenya in September.

Biogen’s shares were trading up 0.5 percent at $57.28 on the Nasdaq on Friday afternoon. (Reporting by Toni Clarke, editing by Matthew Lewis)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below