This Is MS Multiple Sclerosis Community: Knowledge & Support

Hi everyone

Bromley had said that there was going to be a "poster presentation [about Tovaxin] at the 2006 Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS) at the San Francisco Marriott on June 3, 2006." That would be today . Does annyone have any info on that or is it too early for that?? What can I say, I am anxious. I am hoping that they have some new information to add.

NN

sh8un,

You're right about PharmaFrontiers presenting at the FOCIS conference.

FOCIS has their own website. My good neuro is attending the FOCIS conference. The head of FOCIS is Dr David Hafler from Havard Medical School who is doing the work on MS genes (and thought he would be able to identify the genes within a year).

To see the presentation - probably best to check FOCIS or PharmaFrontiers website over the next few days.

This should be an interesting conference as it brings together clinicians and reseachers who cover diseases where the immune system is involved, or is considered to be involved. Although many of us do not buy into the auto-immune theory, projects like the bone marrow transplanation in Canada, show that the immune system is involved in the damage (probably T and B cells).

Ian

Thanx Bromley. As Always you are very helpful. I will check thier sites.

This appears to have a recent date on it, but i didnt notice anything new in the text.
http://www.hypeandhope.com/wt/page/index/it_1118336584

Their website probably has more, i havent checked.

_________________
Gilenya, 80mg Lipitor, Inosine, Minocycline, Suppliments galore.
3 CCSVI treatments, no major noteable benefits thus far.

Hi
I did not even know about this meeting. I am really hoping Tovaxin works. I was wondering what it means when they say phase IIb/III? What does the b part mean???

S,

The following provides details of the various phases, but I'm not sure how a Phase IIb differs from a Phase II.

Ian

A new drug is tested on people only if extensive laboratory work and animal studies show promising results. If a treatment does go on to trial stage, the trials themselves have to progress through a set sequence of ‘phases’ – one to four – to ensure that the information obtained is reliable and everyone taking part is protected. Phase one must be completed successfully, before moving to phase two and so on for the remaining phases. Trials stop if there is any cause for concern.

Phase I trials are small, with between ten and 50 people – and everybody gets the new treatment. Phase I studies reveal how best to give a drug and how much can be given safely. Side effects are unpredictable so people are watched very closely. If the risks are high, for example, a treatment might only be offered to people who can’t be helped any other
way.

Phase II trials find out whether a new treatment is of real benefit to people. They set the optimum dose and continue to monitor side effects. Usually 100 to 300 people are recruited for a relatively short time, around
six months to two years.

Phase III trials are huge studies with anything up to 1,000 to 3,000 participants, often from many different countries. They look at the benefits and side effects of a new drug in the long term – over two to four years –
and nowadays often assess people’s perceptions of their ‘quality of life’ on a new treatment.

Phase III trials need to be large to make sure they can detect small differences between treatments. In the case of a treatment for relapsing remitting MS, for example, even larger numbers may be required to distinguish real effects of the drug from spontaneous recovery.

Recruiting such large numbers of people can take years. As a result, it can be five to ten years before a trial reaches its conclusion. Because each person has to be followed for the same amount of time (two to four years), the last people to be recruited may only be just starting their treatment when the first people are finishing.

Phase IV: Success in phases I to III usually means that the drug will be given a European license, which 3 gives the manufacturers permission to market the drug. Once it is marketed, if it’s then prescribed, monitoring continues for any new side effects that might emerge.

I am sure i have read of drugs being "fast tracked". Is there a formal path/result for this, or is it the pharma just pushing to make their money sooner? With something like MS (where no current treatment offers GREAT benefits) it wouls seem ten years would be too late for most.

Aimspro can be attained, even though it hasnt made it through the phases as far I know.

Cure,

There must be a fast-tracking option. In a disease such as ALS where the life-expectancy is 18 months to 5 years, there would be little point holding back if a treatment in trial showed promise.

The interesting one for me is Rituxan which is in Phase III trails for PPMS. I don't recall seeing a Phase II trial for this drug. If the trial showed that it radically slowed down / stopped progression then it would seem a good case to fast-track. It is already licenced for other diseases, so the safety profile is known.

Safety is important, but if someone is likely to become very seriously disabled, it is not such an issue. An treatments such as Rituxan have been used for rapidly progressing cases.

As the mechansims of this disease become better understood it might be possible to identify a specific molecule which is driving the disease. If a drug was in the labs which was capable of targeting the molecule, getting it on the market ASAP should be the priority. MS doesn't stand still and delays to making treatment available equate to increased disability. Patients with diseases such as this should be given the choice.

I had to do some checking on phase IIb since I've been wondering too...


"A Phase IIB clinical trial typically is a single-arm study aimed at deciding whether a new treatment is sufficiently promising, relative to a standard therapy, to include in a large-scale randomized trial. Thus, Phase IIB trials are inherently comparative even though a standard therapy arm usually is not included."

<shortened url>



"Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements, whereas Phase IIB is specifically designed to study efficacy."

http://en.wikipedia.org/wiki/Clinical_trial#Phase_II

I had looked up articles about Rituxan several months ago when it was the topic of the day. One of the side affects of this drug is death, which I consider a real show stopper.

Ian, your "good" neuro seems to believe it is a possible treatment. Has he mentioned the death aspect?

gwa