View on Tysabri

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby dignan » Sat Nov 19, 2005 10:03 am

Regarding Bromley's comment on Canadian research and HarryZ's followup, here is a little passage from BioMS's quarterly results released on November 14...



Pivotal Multiple Sclerosis Trial Update

BioMS Medical is currently enrolling patients across Canada, the U.K. and Sweden in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). BioMS anticipates completing enrolment in the first part of 2006. To date the trial has successfully completed two safety reviews by its independent Data Safety Monitoring Board.

"We are pleased with the progress being made with this trial," said Mr. Kevin Giese, President of BioMS Medical. "Subsequent to the time-intensive enrolment of the first 100 patients who required extensive safety analysis and were being recruited from a limited number of sites, enrolment is accelerating nicely as the balance of the participating sites are coming on stream and contributing patients to the study. We will continue to provide updates on enrolment as milestones are reached."

http://biz.yahoo.com/cnw/051114/bioms_q ... .html?.v=1
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Postby HarryZ » Sat Nov 19, 2005 10:38 am

Amelia,

IT SHOULD BE OUR CHOICE TO TAKE IT OR NOT.


I totally agree with you..but....in order for a person to make an informed decision, he/she must be given the proper data and information to do so. And there lies the problem for Tysabri.

Up until PML showed up, Tysabri "appeared" to be relatively safe. The drug was approved on one year data from 2 of 99 world wide trials going on at the time. The FDA wasn't totally convinced and one condition of approval was that Biogen/Elan had to complete the Phase III trials and submit that data and safety information to continue the approval.

But what happens...2 MS patients come down with PML. And Biogen/Elan sure knew about the sepsis patients that died. So they had no choice but to "voluntarily" pull Tysabri and step back to see what happened and try and figure things out. By that time, some 5000 general population patients had started on Tysabri and they were left hanging as well.

Now let's speculate on what may have happened if Biogen/Elan had waited to complete their Phase III trials at the end of December, 2004. It would have taken them until approx April,2005 to collect all the trial data and submit it to the FDA approval process. But 1/2 way through that period, the PML patients would have been discovered. I suppose it's impossible to know how the FDA would have reacted to that information while they were about to consider the approval. You can bet that Biogen/Elan would have scrambled and done everything possible to minimize those PML events and presented a much different approval request. But at least there wouldn't have 5000 patients that started then had to stop receiving the drug. And when the drug likely would have approved down the line, MS patients and docs would have had the information available to them to make that important choice.

All very speculative but interesting, to say the least.

Harry
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Postby bromley » Sat Nov 19, 2005 10:47 am

Thanks Dignan,

The Canadian's seemed to be doing some novel things e.g. the small minocycline trial which reported in May 2004, but it's all gone quiet. Also they seemed to be leading on the treatment which kills off the immune system and replaces it with a new one (can't remember the name - must be the MS!). Jack Antel is one of your lead scientists and was awarded MS researcher of the year (although the awards seem to be based on how many research papers you have published rather than how many in wheelchairs walked again - the real test in my view).

Back to Tysabri, Antisense Therapeutics (an Australian company) was working on a drug with a similar mechanism, but the trial was stopped following the Tysabri fiasco. They have just re-started the trial.


For those of us in Europe, I'm not sure whether Tysabri is being assessed for approval by the European equivalent of the FDA? Or what the position is in Canada regarding Tysabri? I imagine that even if Tysabri is approved for re-introduction next spring in the US, that it will be some time before it is available in Europe.


Ian
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Postby amelia » Sat Nov 19, 2005 10:55 am

I have to agree with Harry many posts back. I do believe that Biogen / Elan let "money" drive the force of Tysabri trials. It is blatantly obvious that the trials were not controlled like they should have been. But didn't other drug companies make the same mistakes, Phen-Phen? We live in a greedy society and I am afraid that there really is no one person or company you can completely trust. Do you really know the other drugs we take? For anything? When you go to the DR, he puts you on the "latest" drug for even something simple. Do you know how you are going to react? It really comes down to trial and error and unfortunately, sometimes that can mean your life.
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Postby HarryZ » Sat Nov 19, 2005 10:58 am

Ian,

For those of us in Europe, I'm not sure whether Tysabri is being assessed for approval by the European equivalent of the FDA? Or what the position is in Canada regarding Tysabri?


I don't know about Europe but prior to Tysabri being pulled in the US, Health Canada was reviewing the minimal data that they had for the drug. I was told by the research neuro at the London MS clinic here that Health Canada wasn't in any hurry to approve Tysabri until they saw a lot more data on it. He thought that it would be at least a year (end of 2005) before they would make a decision. I have no idea at the moment where the approval process stands here in view of what has happened.

Harry
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Postby MetsFan » Sun Nov 20, 2005 9:08 pm

http://www.elan.com/news/full.asp?ID=773760

"On September 26, 2005, Elan and Biogen Idec announced the submission of a supplemental Biologics License Application (sBLA) for Tysabri to the U.S. Food and Drug Administration (FDA) for the treatment of MS. The companies have requested Priority Review designation from the FDA. The sBLA includes final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX(R) (Interferon beta-1a) in MS, the integrated safety assessment of patients treated with TYSABRI in clinical trials, a revised label and a risk management plan. The companies have also submitted a similar data package to the European Medicines Agency."

Biogen and Elan have stated that they expect that the European Medicines Agency will respond to the data package in the second half of 2006. The FDA, as you know, will respond by end of March 2006.

I have not heard anything concerning additional submissions to Canada's regulatory authority.
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Postby HarryZ » Mon Nov 21, 2005 10:39 am

Metsfan,

I have not heard anything concerning additional submissions to Canada's regulatory authority.


I e-mailed Health Canada today and asked them the question. I have no idea how long it will take them to get back to me but when I get an answer, I'll let the forum know.

Take care.

Harry
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