Clinical Trials.....

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Clinical Trials.....

Postby fightingms » Fri Mar 05, 2004 5:51 pm

some good info to think about........Kim

Treatment Under Development

As indicated previously, a growing amount of evidence suggests that a disturbance of immunologic function in which lymphocytes, macrophages, and cytokines play crucial roles is of importance in the pathogenesis of MS. Therefore, a number of interventions have been designed to alter or block various steps that have been recognized as important in the inflammatory and immunologic pathways.

A number of fundamentally different strategies can be identified:


To develop agents that induce more selective immunosuppression in an attempt to overcome the potential side effects of global immunosuppression.

To develop compounds that have an effect on cytokine production by shifting the balance from the production of proinflammatory cytokines IL-2, IFN gamma, tumor necrosis factor-alpha (TNF-alpha) to production of antiinflammatory cytokines IL-4, IL-5, and IL-10. The results of the studies that showed that IFN beta reduces both clinical and MRI signs of disease activity and the subsequent observations that this might well be related to an effect on this balance between the production of pro- and antiinflammatory cytokines has been a major stimulus for research to be directed to this area. Some experimental evidence, however, suggests that this type of immune deviation may result in enhanced autoantibody production and more severe disease.

To develop compounds that have an effect on the initiation of the immunologic response in which T lymphocytes are being activated when antigen that is presented by antigen-presenting cells is recognized by specialized receptors on the T lymphocytes. Findings in the animal model EAE have suggested that this approach might be successful.

To develop compounds that stabilize the blood–brain barrier in such a way that activated immune cells are less likely to be able to enter the CNS. The relevance of this type of mechanism has been emphasized by MRI studies that have been performed on patients who initiated treatment with IFN beta, in which it was demonstrated that part of the efficacy of IFN beta might be related to it.

In the opinion of the Committee, for all approaches mentioned in this section, “Treatments Under Development,” more research is needed before their role in the treatment of MS can be determined. At this time their use cannot be recommended outside the context of well-designed clinical trials.

Although proof has become available that we have developed the tools to generate intervention strategies that are effective in the treatment of patients with MS, we must be careful that in this atmosphere of optimism we do not too easily adopt new therapeutic approaches on the basis of results of small studies without phase III trials involving large numbers of patients being performed. This has recently been reemphasized by the unfortunate experience with roquinimex (Linomide®), an immunomodulatory agent that had shown promising effects in two phase II studies but had to be withdrawn from phase III studies, which at that time included almost 1,500 patients, because of unexpected serious (cardiovascular) side effects. In a disease such as MS, where disability generally accumulates slowly over many years, severe side effects, even if infrequent, might invalidate a therapeutic approach.

Which of the interventions described in this chapter will ultimately be a worthwhile addition to our present therapeutic armamentarium can only be decided on the basis of the results obtained in a clinical development program that incorporates appropriate study designs of sufficient duration and sufficiently high numbers of patients.

sorry here is the link for the whole site...http://www.msif.org/en/symptoms_treatme ... velopment/
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Postby finn » Sun May 02, 2004 4:33 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 8:18 am, edited 2 times in total.
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Drug Pipeline.....

Postby 2gentle » Sun May 02, 2004 9:26 am

HI Finn :D

Thanks for the "heads up" on what's new, I'm sure all who read these will appreciate them.
Also, I'm sorry for the relapse you had,and hope you feel better now....

Lastly.....THANK YOU!!! for being a "guinea pig" so to speak, for ALL of us!! May you feel better soon!
Every journey begins with a single step...Diane
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Postby finn » Sun May 02, 2004 10:30 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 8:18 am, edited 1 time in total.
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Clinical trials...

Postby 2gentle » Tue May 04, 2004 6:05 pm

Finn,
Very well put....
Take care,
Every journey begins with a single step...Diane
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Postby Shayk » Tue Jun 15, 2004 7:41 pm

Finn wrote:

I think it is important to share all experiences--good or bad


I quite agree and there was a great article in today's NY Times (6/15) Group Weighs Plan for Full Drug-Trial Disclosure

Seems that the International Committee of Medical Journal Editors may propose that drug makers be required to register clinical trials at their start in a public data base.

It was news to me that
Pharmaceutical companies are not generally required now to disclose results of a trial or even whether one was conducted...fuller registries of drug trials are needed because companies, as well as medical journals and scientists, tend to spotlight only trials that show positive results.


Ideally, advocates of clinical trial registries say, such databases would show when a trial was started, list its objectives and then update that information with the trial's results or the reason it was terminated.


Now, this would be a small step forward in my opinion. And, I kept wondering why I couldn't find info on some drugs I thought were going into trial. :roll: I guess this explains that conundrum. 8O

Link for the article: www.nytimes.com/2004/06/15/business/15drug.html

Sharon
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