Re: PharmaFrontiers obtains positive phase I/II data in MS
- From: "IHaveMS-com" <tim@xxxxxxxxxxx>
- Date: Sat, 06 Aug 2005 15:20:53 -0400
Hi to all,
I am in an FDA trial for an MS vaccine. The vaccine appears to have
arrested my disease and has done the same for the other people in the
study. I have two small websites that show a timeline of events. The first
one is www.ihavems.com It starts with the first injection and goes for 18
months. My websites are little 10-page boilerplate sites, so my timeline
continues on a second website www.timswellness.com from June 2004 to the
present. I am a little behind on the second website. I haven't written
anything since the end of February, but I will get back to it soon. My Dad
and I work on it together.
I am actually out doing things again. I just returned from a solo trip to
see some friends in San Francisco. This is amazing, since two years ago,
my parents were taking me from our home in Michigan to Houston in a
wheelchair.
Tovaxin is an autologous vaccine. That means they take some of my blood,
cull out the T-cells and introduce them to human myelin. Those that react
to the myelin are culled out and replicated. Once there are enough for the
vaccine, about 45 million cells, the T-cells are irradiated so that they
are still alive, but cannot reproduce. That is the vaccine.
The vaccine is injected just under my skin, you can see some pictures at
www.timswellness.com , and the body treats these T-cells as a foreign
invader and makes antibodies to eliminate only these specific T-cells.
These antibodies not only take out the T-cells from the vaccine, but also
eliminate all of that same type of T-cell throughout my body.
The body produces 2 to 3 trillion red blood cells per day. I am not sure
how many T-cells are produced per day, but if 1 or 2 per million are
troublemakers, that means there are hundreds of millions of myelin
reactive T-cells floating around in the blood stream of someone with MS. A
flare is when the body produces too many of these bad T-cells. No one is
sure why this happens, but it may be caused by an upper respiratory
infection, or a cold sore, or some other immune response that triggers the
body to produce T-cells that mistake myelin as something bad.
By eliminating these 1 or 2 per 1 million T-cells does not compromise the
immune system, but it does eliminate all of the T-cells that destroy the
myelin. No bad T-cells means no more attacks. Anyone on Tovaxin will need
to get a booster twice a year to keep the antibodies at a level sufficient
to continue to eliminate all of the myelin reactive T-cells as they are
produced. This is just like a flu shot.
I think about 30 to 40% of the damage that was done by the attacks has
been reversed. The body will repair itself, as long as the attacks stop. I
am helping myself by doing a lot of exercising and activities that improve
my small motor skills.
I am doing many things that I was no longer able to do. When I started the
vaccine, my parent's were cutting my food and feeding it to me. I am able
to cut my own food, and today, I peeled some shrimp. Realizing that I can
again do something as insignificant as peel a shrimp really makes me feel
good. I used to wonder why people got so excited to see a disabled family
member regain some little ability, now I understand, and I understand why
my family is trilled at even my smallest improvement.
The study I am in will be releasing more interim results in October. These
results should result in FDA approval to start phase IIb/III trials.
Enrollment will start at the end of the year in Texas and at the other
sites (I don't know where) after the first of the year.
Best regards, Tim
-----------------------------
The links below would be sources of other information and possible
contacts at the company.
My websites http://ihavems.com/ and http://www.timswellness.com/
The company is PharmaFrontiers and the company website is
http://www.pharmafrontierscorp.com/ There is a very good animation of how
the vaccine works http://www.pharmafrontierscorp.com/toxavin.php The CEO
is David McWilliams dmcwilliams@xxxxxxxxxxxxxxxxxxxxxxxx I am sure he
would be happy to do an interview. He can be reached at the company
1-281-775-0610. The general number is 1-281-775-0600.
The principal investigator for the current studies is Dr. Brian Loftus
BLoftus@xxxxxxxxxxxxxxxxxxxx The study is posted on his website
http://www.loftusmd.com/Articles/MS/TcellvaccineRRMS.html I am sure he
would be happy to do an interview. His number at the clinic is
1-713-797-9191. His assistant is Maryann Murray
mmurray@xxxxxxxxxxxxxxxxxxxx 713-394-2718 Direct, 713-394-2712 FAX.
The inventor of the T-cell vaccine is Dr. Jingwu Zhang. His webpage at
Baylor School of Medicine is http://bcm-neurology.org/faculty/zhang.html
The company would probably need to arrange an interview with him. The
principal investigator for the phase III trials is Edward J. Fox, M.D.,
Ph. D. He is the director of The MS Clinic of Central Texas (Round Rock).
I don't have any phone number of email for him. The company could provide
that.
Here are some links to recent news articles -
ABC News http://abcnews.go.com/Health/wireStory?id=664033
Interim phase I/II results http://biz.yahoo.com/bw/050603/35063.html?.v=1
National MS Centers Meeting Phase III
http://biz.yahoo.com/bw/050608/85342.html?.v=1
Stem Cell Research http://www.stemnews.com/archives/000761.html
MS Neighborhood
http://www.msneighborhood.com/content/in_the_news/archive_2228.aspx
-----------------------------------------
Comparison of Tysabri and Tovaxin
Tysabri was approved last November for use with people suffering from MS.
It reduces the number of attacks by 2/3 verses 1/3 with the current drugs.
It reduces brain liaisons by 90% and reduces the progression of disability
by 44%. It got fast tracked and was heralded as the next generation of MS
treatments. It was the drug that Tovaxin would have gone head-to-head with
in Phase III clinical trials.
What is Tysabri? It is a Monoclonal Antibody
http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/M/Monoclonals.html
-- an antibody that is mass-produced in the laboratory from a single clone
and that recognizes only one antigen. Monoclonal antibodies are typically
made by fusing a normally short-lived, antibody-producing B cell to a
fast-growing cell. The resulting hybrid cell multiplies rapidly; creating
a clone that produces large quantities of the antibody.
MS is considered to be an autoimmune disease in which the person's immune
system attacks the brain and/or spinal cord. Tysabri appears to work by
binding to these immune system cells, thus preventing them from traveling
to the brain where they can cause damage.
Antibodies are proteins produced by a person's immune system to fight
foreign substances, such as infections. Monoclonal antibodies, such as
natalizumab (Tysabri), can be produced in large quantities in cell culture
in a laboratory setting. They can be designed to bind to proteins on the
body's normal cells. By recognizing and attaching to these proteins,
monoclonal antibodies can interfere with (or alter) normal or abnormal
cellular responses. In this way, monoclonal antibodies may be useful in
the treatment of certain diseases such as MS.
What killed the patient? The reports involved at least three cases of
progressive multifocal leukoencephalopathy (PML)
http://healthlink.mcw.edu/article/921450160.html , a rare but often fatal
disease that affects the nervous system. In two of the cases, the patients
had been taking Tysabri for more than two years in combination with another
MS drug, Avonex. In the third case, the person was taking only Tysabri and
was in a Crohn's Disease study.
It is suspected that Tysabri or the combination of Tysabri and Avonex
allowed this rare viral infection to take hold. 80% of all adults have
been exposed to this virus, but it is rare for someone to be affected by
it. Someone with a compromised immune system, such as AIDS, would be a
candidate to get this. Possibly Tysabri or the combination of the two
drugs altered the patients immune system enough to allow the virus to
attack.
PML is a demyelinating disease and it was first thought that these
patients were having an MS attack. There is no known cure for PML and
diagnosis is usually done by autopsy. It may be possible to diagnose it
with a spinal tap, but currently, an MRI assessment is used when PML is
suspected.
What does Tysabri's withdrawal mean to the approval of Tovaxin, and
whether or not Tovaxin will get fast tracked? Tysabri has no bearing on
whether or not Tovaxin gets approved. Tysabri is a monoclonal antibody and
Tovaxin is an autologous T-cell elimination. Tysabri is a laboratory
created antibody that attaches itself to T-cells thus preventing them from
crossing the blood-brain barrier. It stops almost all T-cell from crossing,
not just the bad ones.
Tovaxin http://www.pharmafrontierscorp.com/toxavin.php is a vaccine,
which uses the patient's own blood. Like a flu shot, it makes the body
form antibodies against a select T-cell, which attacks myelin. It does not
interfere with any other T-cells and has no effect on the blood-brain
barrier. There is virtually no health risk. The typical frequency of
myelin reactive T-cells in the blood of a patient with MS is about 1 to 2
per million. Eliminating this small fraction of T-cells from a person's
immune system has very little effect.
Since Tovaxin is autologous and posses little health risk, if a small
portion of patients show improvement (10%), it will get fast tracked. The
current drug escalation trials have show that it is safe and almost all of
the patients have shown improvement.
.
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