new rebif

A board to discuss future MS therapies in early stage (Phase I or II) trials.

new rebif

Postby bromley » Thu Sep 28, 2006 2:38 am

Shame they couldn't have improved its efficacy! The bottom line is it still only reduces relapses by around 30%, but it's easier to take.

Ian

One-year Data From Phase III Trial Show That New Formulation of Rebif(r) Offers Substantial Improvement in Tolerability and Immunogenicity Profiles

Data Presented at 22nd ECTRIMS Congress in Madrid.


Serono announced today data from an ongoing two-year (96 weeks) Phase IIIb trial show that the new formulation of Rebif® (interferon beta-1a) 44 mcg subcutaneously (sc) three times weekly (tiw) for the treatment of relapsing forms of multiple sclerosis (MS) offers substantial improvement in tolerability and reduction in antibody formation observed at one year (48 weeks), compared with historical data from patients. Historical data for the currently available formulation of Rebif® is the EVIDENCE study. These data are presented today at a satellite symposium at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

"These results are promising news for patients with multiple sclerosis," said Prof Per Soelberg Sorensen, from the Danish MS Research Center, Copenhagen University Hospital, Rigshospitalet and an investigator of the trial. "If approved the new formulation of Rebif® potentially represents an improvement in the treatment of patients with multiple sclerosis."

The incidence of injection site reactions with the new formulation of Rebif® at 48 weeks was nearly three-fold less than in the EVIDENCE study (29.6% versus 83.8%). Injection site reactions are one of the reasons why some patients discontinue MS treatment. Treatment enhancements resulting in a decrease of injection site reactions are usually associated with improved compliance and adherence to treatment.

The primary endpoint of the study is the proportion of neutralizing antibody positive patients at the last assessment. At 48 weeks, the data showed that 13.9% of patients treated with the new formulation of Rebif® were neutralizing antibody positive. In the EVIDENCE study at 48 weeks, 24.4% of the patients were positive. Persistent neutralizing antibodies were detected in 2.5% of the patients treated with the new formulation of Rebif® at 48 weeks. In the EVIDENCE study at 48 weeks, the rate of persistent neutralizing antibodies observed was 14.3%.

"The new formulation of Rebif® has been developed by an innovative approach, using state-of-the-art technologies, with a major focus on the molecule's structural and functional integrity," said Franck Latrille, Senior Executive Vice President Global Product Development at Serono. "Based on the improvements in tolerability and immunogenicity, the new formulation of Rebif® could lead to an improved benefit-to-risk profile."

The new formulation of Rebif® is the latest of many product developments from Serono to continually enhance the convenience and tolerability of Rebif®. Other enhancements have included the Rebiject II auto-injector to facilitate injections; a 29 gauge-5 bevel needle pre-filled syringe, the thinnest needle in a ready-to-use pre-filled syringe for the treatment of MS; and a titration pack designed to make starting on Rebif® therapy easier and more convenient. The new formulation of Rebif® is currently under regulatory review by the European Medicines Agency, the US Food and Drug Administration and other healthcare authorities.

The results presented today are the 48-week results from a 96-week, Phase IIIb, multicenter, single-arm, open-label study evaluating the safety and immunogenicity of the new formulation of Rebif® 44 mcg sc tiw in 260 patients with relapsing forms of MS. The primary objective of the study was to compare the antigenicity of new formulation Rebif to historical data.

Source: Serono International S A
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