Final Testing of MS [Multiple Sclerosis] Drug Launched (+ Tysabri info)

SignonSanDiego.com ^ | 1-10-07

[cgk]

Final testing of MS drug launched

Biogen Idec said it has launched final, Phase 3 testing of an oral drug to treat multiple sclerosis. The Massachusetts company, which has a research campus in San Diego, said the drug will be tested in more than 2,000 patients in North America. The studies of BG-12, as the drug is known, are expected to last two years.

The drug would be the third in Biogen Idec's portfolio of multiple sclerosis medicines. In June, the company reintroduced the drug Tysabri with partner Elan Pharmaceuticals based on a risk-management plan that stipulated it must be administered at registered infusion centers.

It had been pulled from the market after two patients died of a rare nerve disorder. The company also makes Avonex, an older MS drug.

[cgk]

Also: (press release):

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1/9/07: Biogen Idec (BIIB) Initiates Phase III Clinical Program of BG-12

Biogen Idec (NASDAQ: BIIB) has initiated the Phase III clinical program of BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS). These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the U.S. later this year.

Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability, and various MRI measures.

Data from a Phase II study designed to evaluate the efficacy and safety of BG-12 were presented at two European neurological medical meetings in 2006. The Phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mg per day orally for six months. The patient group treated with 720 mg of BG-12 per day had a 69% reduction (p<0.001) in the mean number of new gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had a 48% reduction (p<0.001) in new or newly enlarging T2-hyperintense lesions at six months compared to baseline. Although the study was not powered to achieve statistical significance for this endpoint, there was a 32% reduction (p=0.272) in relapse rate compared to placebo at the 720 mg dose. The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo on any endpoints.

[cgk]

MS Ping!

Please FReepmail me if you would like to be added to, or removed from, the Multiple Sclerosis ping list...

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Well the results are in from our UNOFFICIAL Tysabri poll -- THANKS TO ALL WHO RESPONDED TO A REQUEST FOR INFO FROM A FELLOW FREEPER/MS SUFFERER! - it appears noone on FR has experience with this drug treatment YET, but plenty of you have info on where all of us can read about it from those who DO use it! Instead of sending out a mass FReepmail to the MS list, I thought it might be more beneficial to post a thread with the links for Tysabri and MS information. Please see below and thanks again to all who helped with this list!

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TYSABRI INFORMATION & LINKS:

ThisIsMs.com, "there is a forum specific to Tysabri there - scroll down".

Message board from Massachusetts General Hospital for MS patients "Many participants are currently using Tysabri and regularly post their experiences with the drug here."

MS World, "a special board where they share info on treatments and medications and there are several people on that board that are taking Tysabri."

NeuroTalk, several threads on Tysabri from those who take the drug.

HealthBoards.com, Tysabri info from MS patients.

Lauren: Living With MS BLOG, Tysabri Diary.

[marvlus]

Thank you for your continued support of this ping list!

[Quix]

PING

[2ndClassCitizen]

The BG-12 appears to be more effective than the present crab drugs.

Is that your take from the small study so far?

I realize that this is very early on.

[octobersky]

Happy New Year and thank you so much for starting this informative thread, cgk.

[hummingbird]

Oh, this is interesting, cgk. I was a "lab rat" for oral interferon, a 6 - week program some time ago.

All seemed to go well until week 6. Within two hours, maybe even one hour, a pattern of what looked like purpura or petekia (sic? on both) appeared on my arms and legs.

If I recall correctly, it gradually disappeared within a couple of days but one of my doctors said that there was a definite change in my cognitive and emotional abilities after being in that study.

I heard later that of all the people who participated in the test, those who took the real interferon orally all had some kind of reaction. One might say it was a failed test, but even the tests that don't go as predicted, teach us something, I suppose.

I haven't been able to find an abstract or summary anywhere. Also, as you know, I cannot take any of the interferon-based MS medications.

Wonder what this substance is...still haven't had my nap!

[hummingbird]

Oh, this is a great list. I'll check the msg I got and see if it is already on your list.