Re: FDA trial for a new MS vaccine Tovaxin
- From: "Tee" <tnospam@xxxxxxxxxx>
- Date: Sun, 7 Aug 2005 12:04:09 -0500
Tim,
What a great sites. I found them very interesting. I hope this is the
"it's just around the corner" cure that we've all been waiting for.
Thanks for sharing your sites with us!
Tee :)
"IHaveMS-com" <tim@xxxxxxxxxxx> wrote in message
news:06c03f3c5e74f5d1198bb22f5f9404a3@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
| 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.
|
.
- References:
- FDA trial for a new MS vaccine Tovaxin
- From: IHaveMS-com
- FDA trial for a new MS vaccine Tovaxin
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