A USC-invented vaccine for multiple sclerosis New Trial

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

A USC-invented vaccine for multiple sclerosis New Trial

Postby Nemotoday » Tue Nov 30, 2004 9:50 am

Early days, but an interesting approach.

A USC-invented vaccine for multiple sclerosis (MS) is about to enter
Phase II clinical trials

A USC-invented vaccine for multiple sclerosis (MS) is about to enter
Phase II clinical trials, backed by a combined $3.5 million in
funding-including a $1.1 million award from the National Multiple
Sclerosis Society that is one of its largest in recent memory, as well
as $2.4 million from the National Institute of Neurological Disorders
and Stroke (NINDS).

While the vaccine is unlikely to rid patients of their current MS
symptoms, said Keck School of Medicine professor Leslie Weiner, chair of
the Department of Neurology and co-inventor of the vaccine, results from
the Phase I study on four patients indicate that it may well be able to
halt the disease in its tracks.

Weiner and former faculty member Jorge Correale, now head of neurology
at FLENI, a foundation and neurologic institute in Buenos Aires,
Argentina, that is involved in the fight against neurological diseases,
came up with the idea for the vaccine together some 6 years ago. A
patent is currently pending, and the Phase II trial has an
Investigational New Drug number, which means the Food and Drug
Administration has looked at and approved the trial.

Multiple sclerosis is a chronic and oftentimes progressive and
debilitating condition that affects some 250,000 to 350,000 Americans.
According to the NINDS, physicians diagnose 200 new cases of MS each
week. It seems to be an autoimmune condition, a disease in which certain
white blood cells turn on the body that produces them.

The best current hypotheses say that MS is caused by the body's T-cells
attacking the myelin sheaths that serve as the insulation for the
conduction of electricity and coat and protect the long, delicate axons
of the brain's neurons.

"This vaccine allows the patient's immune system to take control of the
disease," said Weiner. "At the end of two years of vaccinations, we hope
they will never need treatment again."

Weiner and his USC colleagues are currently recruiting patients for the
three-year-long trial, in which 40 people with MS will receive the
active vaccine and another 40 will receive a placebo.

Patients are eligible for the trial if they have what is known as
secondary progressive multiple sclerosis-they had periods of both
remission and relapse for some time, and now are experiencing a
significant progression of the disease (though they may still be
symptom-free at times). They also must be between 12 and 65 years of age
and be able to walk at least 50 feet, though use of a cane or walker is

"It's a very hard task to take sick patients and ask 40 to get a placebo
and go off everything else," Weiner admitted. "But we think it's worth
it because of the potential benefits of this vaccine." In addition, he
noted, most of the patients in this trial will likely be treatment
failures on the limited number of treatments available for MS, and so
abandoning those treatments should not be detrimental.

Patients accepted into the trial will have a baseline MRI to measure the
MS lesions in their brains, and then will undergo a process called
leukapheresis, in which their white blood cells are removed from their
body. (Since the body is continually producing white cells-and in fact
will replace the ones removed within 24 hours-this does not have any
long-term effect.)

To create an individualized vaccine, the research team will then expose
those cells to myelin from a cow brain, which should prompt the
characteristic MS response from the misguided, autoimmune T-cells. (The
cow brains have been examined for any evidence of the so-called mad cow
disease-bovine spongiform encephalopathy-in collaboration with Nobel
laureate Stanley Prusiner of the University of California, San
Francisco, and have been approved for use in the preparation of these

Those T-cells are then exposed to 12,000 rads of radiation, killing them
and at the same time altering them subtly, so that when they are
reintroduced into the body, they will be seen as foreign. That
reintroduction-or vaccination-should prompt the immune system to create
antibodies and reactive T-cells against the MS-causing T-cells. "We
vaccinate them against their own bad T-cells, their own bad
lymphocytes," Weiner explained. "After that, they should be immune to
the cells they produce that attack their white matter at any time in the
future, because they have a memory for the bad T-cells."

How will this help the patient? Simply put, if the body destroys the
autoimmune T-cells before they can get to the myelin, this
sometimes-devastating disease should be stalled in its tracks. "We don't
anticipate that it will get anyone out of a wheelchair," said Weiner.
"But we think we can prevent the progression of the disease. We will
have made their immune systems 'normal' again, leaving the future repair
of their nervous system an easier task."

Vaccines will be created for both the vaccine and placebo groups. If the
trial shows that the vaccine is useful, it may be possible to then
vaccinate the placebo group as well.

Weiner is optimistic about the vaccine's chances.

"We're giving them weapons to kill their self-immune responses, which
you and I can do on our own. In the vaccinated patients, the good
T-cells are interacting with the bad T-cells and killing them."

The patients will receive vaccinations every month for three months, and
then every three months for two years at the General Clinical Research
Center, an NIH-supported facility at LAC+USC Medical Center. The third
year of the study will simply be follow-up, to see whether the effects
of the vaccination persist over time.

The vaccine will be deemed successful if it can halt the progression of
existing lesions and the appearance of new MS lesions, as measured by
MRI. Weiner and his colleagues will also look at any changes in
neurologic function and will be monitoring any and all side effects of
the vaccine.

From a scientific point of view, Weiner noted, the study will most
likely put the lid on the debate over whether myelin is indeed the
immune system target in MS; scientists have long assumed that to be the
case, but it has yet to be definitively proven.

An even more interesting question that the trial will address, he noted,
is just how the immune system is able to get quite so out of control,
spewing out the literally self-destructive T-cells at an ever-increasing

"The implications of this trial are really quite interesting," said
Weiner. "We've made a case that this is worth doing scientifically.
Overall, I think this trial is very exciting for USC, especially since
the vaccine was invented, developed and manufactured here."
by Lori Oliwenstein.

Regards to all
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lid on the debate

Postby feesher » Tue Nov 30, 2004 10:15 am

"the study will most likely put the lid on the debate"

Darn tootin! Of course it'll be 2 years from now, but this is exciting in that it could possibly disprove the autoimmune theory.
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Postby Outlawbiker » Tue Nov 30, 2004 10:24 am

In the famous words of Arnold Horshack:

"Ooh, ooh, ooh!" :o

This sounds FANTASTIC!!
Dx RRMS 10/2000

Rebif- 2002-present
Provigil- 2001-present
Baclofen- 2000-present
relapses since 2000------ZERO!!!!!
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Postby OddDuck » Tue Nov 30, 2004 10:24 am

You know, that is interesting. I touched upon this same type of work being done by the Department of Neurology at Baylor College of Medicine in an earlier thread here.


Same theory, it appears.

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Postby elaine » Tue Nov 30, 2004 11:57 am

:?: hi don't want to put a downer on this but this information was printed in 1999 surley we would have heard more about it by now?????
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Postby OddDuck » Tue Nov 30, 2004 12:07 pm

Good point, Elaine.

But what I have found quite often is that lots of things for or about MS are or have been "in the works" for many years before anyone hears a thing about it.

It takes some digging and a lot of "watching" and researching to keep abreast of what is actually going on behind the scenes. There's a mountain of research and treatment theories going back a number of years, that is only just now coming to the forefront in the "news".

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Postby Arron » Tue Nov 30, 2004 12:20 pm

don't quote me as I cannot find the source, but I *think* this trial failed... I will dig.
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Postby OddDuck » Tue Nov 30, 2004 12:47 pm

Your memory is probably serving you correctly, Arron. From what I recall from the similar work Baylor was doing in this area, also, they hadn't quite reached a completely viable success rate yet, either.

But in the process, from what I gathered, they were discovering interesting and productive tidbits of information that might yet serve to transform their ideas and processes into something more viable.

Nothing concrete yet, though.

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Postby billf » Tue Nov 30, 2004 3:07 pm

I too read that this trial failed and was cancelled. I don't remeber the source but dig and you will find it.
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Postby cdaw » Tue Nov 30, 2004 4:25 pm

I think were really dealing with 4 different diseases - from the info of the lession project at the Mayo. 2 of them may well be infection based, and two of them autoimmune based.If thats the case and research dosent grasp it, no trial of a single therapy will be overwhelmingly effective, unless we can sort out who has what beforehand. Curently you have to have a biopsy to find out. 8O
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Postby Dadio » Fri Dec 31, 2004 7:53 pm

I have thought my MS was triggered by infection, but have not heard much about the different varieties. Especially since my Spinal Tap didn't show anything out of the ordinary. I am on Avonex for one year and stable, so I don't want to mess with experimental therapies. I am curious about the various forms of the disiease, and their symptoms. I was diagnosed Primary-Progressive, but have not gotten any worse during the past year.
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T Cell Vaccination Fails in Trial

Postby radnaim » Tue Jan 25, 2005 7:24 am

http://www.mult-sclerosis.org/news/Mar2 ... Trial.html

March 4, 2004
Paul Jones
All About Multiple Sclerosis

A four year trial of a potential multiple sclerosis treatment at the University of Southern California has been terminated.

The treatment involved vaccinating the body against the immune system cells, called T Cells. These T Cells were believed to be causing the damage to the brain and spinal cord that gives rise to the symptoms of MS.

The study compared the results of the vaccine against those of a placebo injection. It was headed up by Dr. Leslie Weiner and Dr. Norman Kachuck

The study's sponsors, the National Institute of Health and the National Multiple Sclerosis Society of America, decided to stop the clinical trial because it failed to show statistically significant results.

"Their conclusion was based on a failure to show any benefit to the patients who received the vaccine.", said Dr. Weiner. "The data showed that there was no difference between the group of patients treated with the T-cell vaccine and those on the placebo."

"The committee recommended that no more injections be administered to patients. As the principle investigator, I agree with this decision.", continued Dr. Weiner.

Dr. Weiner recommended that study volunteers switch either to Betaseron or to Novantrone.

Copyright © 2004, All About Multiple Sclerosis
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Postby Arron » Tue Jan 25, 2005 11:16 am

There it is! Thank you for finding the information regarding the failure of this trial.
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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