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Edmonton-based BioMS Medical Corp.'s multiple sclerosis treatment has been given fast-track designation by the U.S. Food and Drug Administration.
The drug, Dirucotide, is currently in a Phase 3 clinical trial involving 510 patients at 68 sites.
"Our receipt of fast track designation for Dirucotide in the U.S. is a significant milestone for both BioMS Medical and the MS community," CEO Kevin Giese said.
"Based on previous clinical results, we believe Dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options."
A Phase 2 study and long-term follow-up treatment showed the drug safely delayed median time to disease progression for five years.

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This drug looks really good and I am excited about it. They have also started trials for RRMS, so there may be a better way for these patients than the current CRABS.

The financial blogs are slobbering all over themselves about this drug, which is being classified as a financial blockbuster.

Harry will be happy! (Me too)

gwa

delayed median time to disease progression for five years

What does this mean?
What does it mean for an SPMS'er? That it buys one 5 years of stability?

Terry

Terry wrote: What does it mean for an SPMS'er? That it buys one 5 years of stability?

Yeah, I think that's what they're claiming, Terry..I guess the average length of time participants had until any progression on the EDSS scale was five years...some more, some less. The Maestro 3 study is being fast tracked in the US. This drug is like copaxone, in that it's a myelin based protein that is given intravenously in an infusion...but not every a shot every day, only every six months.

It's certainly not a cure, but a stabilizer for SPMSers, like copaxone is for RRMSers.
AC

Cheerleader, where can I read more about this drug? You seem to have more info... thanks in advance, Carolew

Hi Carolew,
The trial, Maestro 3, is at 68 sites in the US-it will last 2 years.
Looks like it is full, but I'd still check into it.
Here's the info
http://www.biomsmedical.com/clinical-tr ... tro-03.php

Here's the clinical trial link:
says still recruiting, but might be old-
clinical trial

This is an article out of Forbes that is enlightening about the drug.

http://www.forbes.com/healthcare/forbes ... 1/062.html

gwa

Thanks for the updates Cheerleader and GWA. This one is getting close.

I'm not really sure about it, but I think maybe one of the reasons the Maestro-3 trial in the US has been fast tracked is that the Maestro-1 trial (phase 2 / 3) done internationally (http://www.biomsmedical.com/clinical-tr ... tro-01.php) will wrap up in January 2009. So hopefully, we will hear results of that trial in the first quarter of 2009. I think that the FDA might accept 1 year results from Maestro-3 if the 2 year results from Maestro-1 are good, and they should already have those Maestro-1 results when 1 year of Maestro-3 is done.

So if everything went really well, it seems possible that it could be approved in the US by the end of 2009. I'm not sure, but I think it's possible that it could be approved in other countries (Canada, EU etc) earlier in 2009 if trial results are good.

Has anyone participated int he trials? How are you feeling?

thanks for the links cheerleader.. Carole

thank you GWA, Carole

My wife's aunt is in the trial. She has had MS for over 30 years and she says she feels nothing, but her MS is 'dug in' pretty good. She says she feels no side fx, so that's good, but she doesn't feel anything improving either. Those of you who have heard me talk of her know that she has been in about the same shape for as long as I've known her. She's a little slower here lately, but she's also getting on in years. Everything I've read about it seems promising, but so did Tovaxin when I read about it and it isn't doing much for me seeing as how I just got upgraded from a 3 to a 4 today at my 5th shot EDSS evaluation. But I hear it's helping others.

If the BioMS is getting 'fast-tracked' there must be something to it, eh? I'm very slowly starting to have to come to grips that I am probably progressive so I will be keeping an eye on this one.

Loobie wrote:My wife's aunt is in the trial. She has had MS for over 30 years and she says she feels nothing, but her MS is 'dug in' pretty good. She says she feels no side fx, so that's good, but she doesn't feel anything improving either. Those of you who have heard me talk of her know that she has been in about the same shape for as long as I've known her. She's a little slower here lately, but she's also getting on in years. Everything I've read about it seems promising, but so did Tovaxin when I read about it and it isn't doing much for me seeing as how I just got upgraded from a 3 to a 4 today at my 5th shot EDSS evaluation. But I hear it's helping others.

If the BioMS is getting 'fast-tracked' there must be something to it, eh? I'm very slowly starting to have to come to grips that I am probably progressive so I will be keeping an eye on this one.

loobie,

I am just wondering if the trial your aunt is in is double blind or if she knows for sure that she is on the drug.

gwa

Dirucotide does not meet primary endpoint in Phase III

INDIANAPOLIS and EDMONTON, Alberta, July 27 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study.

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