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New Rebif formulation Phase IIIb Results

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CureOrBust

Post subject: New Rebif formulation Phase IIIb Results

Posted: Wed Oct 01, 2008 5:43 am

Family Elder

Joined: Wed Jul 27, 2005 3:00 pm
Posts: 2735
Location: Sydney, Australia

I looked for a post of these, but couldn't find it here.

Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis

Quote:

Date:9/21/2008

-- Study meets primary endpoint by demonstrating significant effect of new formulation of Rebif(R) on disease activity as measured by MRI after 16 weeks of treatment

-- Data presented at late-breaking session of the World Congress on

Treatment and Research in Multiple Sclerosis in Montreal, Canada

GENEVA, Sept. 22 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the ongoing IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study met its primary endpoint. The primary objective of the study was to evaluate the efficacy of the new formulation of Rebif(R), compared to placebo, in patients with relapsing-remitting multiple sclerosis (RRMS) and active disease by means of magnetic resonance imaging (MRI) at the end of 16 weeks of treatment. The 16- week study results show that the mean number of combined unique active brain MRI lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif(R) compared with those receiving placebo, a statistically significant result (p<0.001). These data were presented at the late-breaking session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.

"Patients who received Rebif(R) experienced far fewer new active brain MRI lesions than the placebo group after 16 weeks of treatment," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa, Director of the MS Research Clinic at the Ottawa Hospital, and an investigator of the IMPROVE trial. "These data demonstrate a significant effect of the new formulation of Rebif(R) on disease activity and provide further evidence of its benefit in treating patients with relapsing-remitting multiple sclerosis."

The IMPROVE study is a two-arm, randomized, double-blind, controlled, multicenter, international Phase IIIb study to evaluate the efficacy, safety and tolerability of the new .....

SOURCE Merck Serono
Copyright©2008 PR Newswire.
All rights reserved

the result looks pretty impressive (for a CRAB). The article goes for a few more pages.

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ursula

Post subject:

Posted: Wed Oct 01, 2008 7:04 am

Family Member

Joined: Mon Sep 22, 2008 3:00 pm
Posts: 76
Location: germany

I think they just need good news - brand new figures - because the patent for rebif will expire soon.
As far as I know they didn´t even change the formula of the Interferon itself but only the excipient.
So why should the "new" Rebif work more than twice as good as the old one??
Besides that, the period of 16 weeks is ridiculous for MRI results.

Why didn´t they start this trial: new Rebif versus old Rebif.
That would be interesting indeed...

_________________
ursula

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CureOrBust

Post subject:

Posted: Thu Oct 02, 2008 3:28 am

Family Elder

Joined: Wed Jul 27, 2005 3:00 pm
Posts: 2735
Location: Sydney, Australia

ursula wrote:

Why didn't they start this trial: new Rebif versus old Rebif.

That's what "surprised" me at first. It seems logical if you had "improved" the formulation, this would be a true test of the difference the change has made. It is also questionable (I think) for a company to be having a true placebo arm, when testing a revision of an existing "first line" treatment, which is also theirs. I am surprised they got the test plan passed the ethics committee.

Do you have any support to the statement that they have not changed their formulation? By the way, I once used Rebif myself, and had my worst relapse on it, as well as heavy reactions / side effects, so I am by no means a "fan".

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ursula

Post subject:

Posted: Thu Oct 02, 2008 4:19 am

Family Member

Joined: Mon Sep 22, 2008 3:00 pm
Posts: 76
Location: germany

A new formulation of subcutaneous (s.c.) interferon-{beta}-1a has been developed (Rebif® New Formulation, RNF), produced without fetal bovine serum and without human serum albumin as an excipient, with the aim of improving injection tolerability, and reducing immunogenicity.

http://msj.sagepub.com/cgi/content/abst ... 08097299v1

In all their press releases they avoid to admit that their "new" Rebif in fact hasn´t change very much.
They also claim that the new Rebif reduces the antibodies - I´m sorry, I can´t believe that.
All the Interferon-manufacturers have been cheating on the antibody rate in the past - that´may oponion.
By the way: Schering claims that even their (old!!) betaseron reduces relapses for 79% all of a sudden (unfortunately, I don´t know anyone who believes them, do you?)

I have also taken Rebif for a couple of months (with almost all the possible side effects!)
It´s a shame how much money they make with their crab stuff..

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