Hi ,
I see you have an earlier posting on Tovaxin. I have pasted in a recent press release about Tovaxin. The company has been invited to present at the International MS Meeting in Greece. This at the end of September and the beginning of October.
The vaccine delivery platform for MS is the same as will be used for the rest of the big 6 autoimmune diseases -- Type One Diabetes, Rheumatoid Arthritis, Crohn's Disease, Psoriasis, and Lupus.
I will also paste in a small synopsis of how I have been doing in the FDA trial for Tovaxin.
Best regards, Tim
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Here are a few links to the press release. The first one is Yahoo Health.
biz.yahoo.com/bw/050810/105158.html?.v=1 or
www.rednova.com/news/display/?id=203030&source=r_health August 10, 2005 04:00 AM US Eastern Timezone
PharmaFrontiers to Present Tovaxin(TM) Research at International Multiple Sclerosis Meeting
THE WOODLANDS, Texas--(BUSINESS WIRE)--Aug. 10, 2005--PharmaFrontiers Corp. (OTCBB:PFTR), a company involved in the development and commercialization of cell therapies, announced today that their research of their Phase I/II clinical trials of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis, has been accepted for presentation at the 21st Congress of the European Committee/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis to be held September 28 - October 1, 2005, in Thessaloniki, Greece. The interim trial results have indicated that the treatment appears safe and well tolerated.
Tovaxin(TM) is a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells.
In addition to the safety and tolerance indications, the study concluded that MRTCs in patients with MS can be depleted by Tovaxin(TM) treatment. Multiple Sclerosis Impact Scale (MSIS) and Kurtzke Expanded Disability Status Scale (EDSS) clinical measures are improved.
"Having the opportunity to present such encouraging data from Tovaxin(TM) clinical trials at such a prestigious international MS meeting is a great honor and very exciting for our researchers and all of the PharmaFrontiers staff. The acceptance of our abstract confirms our confidence as we move ahead with the development of Tovaxin(TM) for the treatment of patients who are in the early stages of MS," said David B. McWilliams, chief executive officer of PharmaFrontiers. "With our clinical development partner, INC Research, Raleigh, NC, we plan to initiate this pivotal Phase IIb/III clinical study of early relapsing MS patients by the first quarter of 2006 to advance our understanding of this novel T cell therapeutic vaccine for MS."
The presentation, "Autologous T Cell Therapy in Multiple Sclerosis: An Open Label Safety and Dose Range Study," is authored by Brian D. Loftus, MD, director of Neurology Research and Diagnostic Clinic of Houston (and principal investigator for PharmaFrontiers' two current Phase I/II clinical trials of Tovaxin(TM)), Mitzi Montgomery, DVM, PhD, PharmaFrontiers VP of Discovery and Preclinical Development, and Jim C. Williams, PhD, PharmaFrontiers Chief Operating Officer.
Previous studies of T cell vaccination conducted by Jingwu Zhang, M.D., Ph.D., Director of Research, Baylor Multiple Sclerosis Center at The Methodist Hospital, and colleagues have shown that a monovalent (MBP selected MRTCs) formulation was safe and potentially beneficial in relapsing remitting and secondary progressive patients.
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Hi to all,
I am in the FDA trial for Tovaxin, 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. My Dad and I work on it together.
I have a thread "Tovaxin new MS vaccine" going on Montel's Corner.
www.spotlighthealth.com/common/forum/topics.aspx?m=2&sb=12 In it, I discuss being in an FDA trial for Tovaxin, which is a vaccine that targets and eliminates the myelin reactive T-cell that cause MS.
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. The company has a nice animation of how Tovaxin works at
www.pharmafrontierscorp.com/toxavin.php 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.
After presenting the data at the International Meeting at the end of September
home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20050810005158&newsLang=en, the company hopes to use these results to gain 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.
The company is PharmaFrontiers and the company website is
www.pharmafrontierscorp.com/ The CEO is David McWilliams dmcwilliams@pharmafrontierscorp.com. The principal investigator for the current studies is Dr. Brian Loftus BLoftus@diagnosticclinic.com The study is posted on his website
www.loftusmd.com/Articles/MS/TcellvaccineRRMS.html To get on the list for the next trial of Tovaxin, the best person to email is Shannon Inman sinman@pharmafrontierscorp.com . She works for the company and is keeping a file of interested people. There will be sites throughout the US and some in Canada. There may be some outside of North America.
Best regards, Tim
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My websites
ihavems.com/ and
www.timswellness.com/ The company is PharmaFrontiers and the company website is
www.pharmafrontierscorp.com/ There is a very good animation of how the vaccine works
www.pharmafrontierscorp.com/toxavin.php The principal investigator for the current studies is Dr. Brian Loftus BLoftus@diagnosticclinic.com The study is posted on his website
www.loftusmd.com/Articles/MS/TcellvaccineRRMS.html Here are some links to recent news articles -
ABC News
abcnews.go.com/Health/wireStory?id=664033 Interim phase I/II results
biz.yahoo.com/bw/050603/35063.html?.v=1 National MS Centers Meeting Phase III
biz.yahoo.com/bw/050608/85342.html?.v=1 Stem Cell Research
www.stemnews.com/archives/000761.html MS Neighborhood
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
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)
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
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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Comparison of Tovaxin and Campath-1H
Multiple Sclerosis is both an autoimmune disease and a neurodegenerative disease. It is generally considered to be an autoimmune disease which results in neurodegeneration.
A neurodegenerative disease is a disorder caused by the deterioration of certain nerve cells. Changes in these cells cause them to function abnormally, eventually bringing about their death. The diseases, Alzheimer's, Parkinson's, Creutzfeldt-Jakob, Amyotrophic Lateral Sclerosis (Lou Gehrig's Disease), Huntington's Disease, Frontotemporal Dementia (Pick's Disease), Prion Diseases as well as Multiple Sclerosis, are due to neuronal degeneration in the central nervous system.
An autoimmune disease is when your immune system attacks itself by mistake. Autoimmune diseases can affect many parts of the body, like nerves, muscles, endocrine system, connective tissue, and digestive system. Some of the more common autoimmune diseases are Multiple Sclerosis, Type One Diabetes, Rheumatoid Arthritis, Psoriasis, Graves’ Disease, Lupus, and Crohn's Disease. In each of these diseases the body own T-cells misidentify myelin, islet cells, etc., and attack those cells as if they were an unwanted invader.
The two treatments both target the T-cells that are considered responsible for the attack on myelin. The difference is that Campath-1H is a monoclonal antibody (Tysabri is a monoclonal antibody) and Tovaxin is a targeted T-cell elimination.
A targeted T-cell elimination is where a vaccine is made from the person's own myelin-reactive T-cells. A sample of blood is taken from the patient and the white blood cells are removed. The white blood cells are then introduced to human myelin, and those that react to it are culled out. This small amount of cells, usually 1 or 2 per 1 million are grown in the lab. Once the number of cells has reached 100 million, a dose (30 to 45 million cells) is removed and attenuated (radiated enough to break the DNA chain so that they cannot replicate, but still alive). A vaccine from live cells is like the difference between the Salk and Sabin Polio vaccines. This causes a much greater immune response. It is this immune response that forms antibodies that specifically target the patient's myelin-reactive T-cells. Once the patient has a sufficient number of these antibodies, the number of myelin-reactive T-cells approaches zero and no more myelin destruction occurs.
The improvement in EDSS from both treatments is probably due to the fact that the disease progression has been halted. If the disease is arrested, the body can begin rebuilding. and your EDSS should go down. Both of these treatment go to the root of the problem and eliminate the T-cells that cause the myelin destruction. Tovaxin eliminates 1 or 2 per 1 million T-cells. From what I have read about Campath-1H, it appears that the treatment eliminates all of the patents T-cells, not just the bad one. I will paste in a portion of an interview from July 21, 2003 in which Dr. Jacobs in which he describes the history of Campath-1H and how it works.
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Reported July 21, 2003
New Hope for MS -- Full-Length Doctor's Interview
In this full-length doctor's interview, Daniel Jacobs, M.D., explains how a new drug targets destructive white blood cells in MS patients and could stop the disease in its tracks. Ivanhoe Broadcast News Transcript with
Daniel Jacobs, M.D., Neurologist,
TOPIC: New Hope for MS
Tell me about the history of this new treatment for MS.
Dr. Jacobs: Campath-1H is a monoclonal antibody that attacks T-cells, which are the cells that attack the myelin in multiple sclerosis. This drug is given as an infusion. Patients don’t have to get daily shots. They can get an intravenous infusion of drug for five days a year without shots, and it will reduce their relapses and improve the MRI signs of multiple sclerosis. We have not studied it in a huge number of patients yet, so we cannot make any claims about efficacy. But the pilot studies suggest that it’s very effective and maybe more effective than the existing treatments for multiple sclerosis.
Explain to me how Campath-1H works.
Dr. Jacobs: The drug is a new type of drug called a monoclonal antibody that attacks certain types of white cells that attack the brain and spinal cord and cause multiple sclerosis. It helps prevent the attacks of multiple sclerosis. The drug is a new class of drug called monoclonal antibodies, which attack certain white blood cells that attack the brain and spinal cord and turn these white blood cells off. As a result, multiple sclerosis relapses can be eliminated.
