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Tovaxin, an MS vaccine

TovaxinTM is a novel therapeutic vaccine that parallels the concept of autologous cancer vaccines. Instead of modifying cancerous cells, Tovaxin TM consists of modified autoreactive T cells. Modification of these cells during the vaccine production process causes them to elicit an immune response when injected back into the patient. This immune response is directed against T cells within the patient that are self-reactive with myelin. This immune response, directed against a specific subset of autoreactive T cells, greatly reduces the number of these autoreactive cells in MS patients. TovaxinTM has considerable potential because it attacks the underlying cause of MS rather than just addressing its symptoms.

Read more here.

December 8, 2003 in research, worth following... | Permalink

Comments

I'd like to learn more about this treatment and how I can become apart of the study.

Posted by: Cande Calhoun Richardson at Dec 2, 2005 10:01:20 AM

How can I get into this trial? I have 5 kids aged 4 to 13 and want to be a full-time active mom again. Thanks!

Posted by: Diana Denny at Nov 10, 2005 8:57:02 PM

I HAVE MS & WOULD LOVE TO BE ON THIS TRIAL.

Posted by: DEBORAH WALTER at Oct 26, 2005 2:12:26 PM

HOW CAN I GET INTO THIS TRIAL/STUDY?

Posted by: DEBBIE WALTER at Oct 25, 2005 10:55:25 AM

92% reduction in MS attacks and reduced disability. http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20051003005233&newsLang=en
PharmaFrontiers Presents Positive Tovaxin(TM) Research at International Multiple Sclerosis Meeting
Monday October 3, 5:00 am ET


THE WOODLANDS, Texas--(BUSINESS WIRE)--Oct. 3, 2005--PharmaFrontiers Corp. (OTCBB:PFTR - News), a company involved in the development and commercialization of cell therapies, presented positive interim research findings of its Phase I/II clinical trials of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis on Friday, September 30, 2005, at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) congress held in Thessaloniki, Greece. The trial results not only indicated that the treatment appeared safe and well tolerated with no dose-limiting toxicities, but that Tovaxin depletes the myelin-peptide reactive T cells that may contribute to the Multiple Sclerosis (MS) disease processes.
Tovaxin 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.

The Tovaxin treatment depleted MRTCs in patients with MS. The patients in the trial also had improvements in the Multiple Sclerosis Impact Scale (MSIS), which measures subjective physical and psychological parameters, and the Kurtzke Expanded Disability Status Scale (EDSS), which is an objective measure of the patient's physical disability.

"Seeing safety, tolerance and early effectiveness data at this stage of development is gratifying. More important is seeing the lowering of the MRTCs and the improvement in the clinical measures that reaffirms our belief that Tovaxin may be the key to treating patients who are in the earlier stages of MS," said David B. McWilliams, chief executive officer of PharmaFrontiers. "Based on mounting evidence from our research and others, we believe that autoimmune mechanisms directed at myelin tissue of the central nervous system may play a major role in causing MS.

"With our clinical development partner, INC Research, Raleigh, NC, we plan to initiate a follow-on Phase IIb clinical study of clinically isolated syndrome and early relapsing-remitting MS patients by the first quarter of 2006 to advance our understanding of this novel T cell therapeutic vaccine for MS," said McWilliams.

MRTCs play a critical role in the pathogenesis of MS. Previous T cell therapy pilot studies used a monovalent formulation of attenuated MRTCs to deplete MBP reactive T cells. Because several myelin antigens are described as potential autoantigens for MS, depletion of MRTCs using a trivalent formulation may have enhanced therapeutic effects.

The dose escalation study was designed for patients with relapsing-remitting or secondary-progressive MS, intolerant of, or having failed, current therapy. Blood was obtained from each patient from which T cells reactive to two peptides each of three proteins (MBP, PLP, and MOG) were expanded ex vivo and prepared as a trivalent formulation of MRTCs. The MRTCs were attenuated by Cesium137 irradiation prior to patients receiving subcutaneous injections of either 6-9 million cells (Dose 1) or 30-45 million cells (Dose 2) at weeks 0, 4, 12 and 20. MRTC frequencies were performed at baseline and weeks 5, 13, 21, 28 and 52. Patients were evaluated for changes in EDSS, MSIS and exacerbations.

"Tovaxin is a patient-specific therapeutic vaccination strategy for MS patients. To formulate Tovaxin T cell vaccine, the patient's own myelin peptide-specific activated T cell lines are harvested and attenuated on the day of vaccine administration," said Jim C. Williams, Ph.D., PharmaFrontiers chief operating officer and co-author of the study who presented at the meeting. "The shelf-life of the final product is approximately three days."

The study's results demonstrated that MRTCs in the peripheral blood were depleted in a dose dependent manner and analyses showed reductions in all three types of MRTCs at all follow-up visits. All patients in the Dose 2 group had a 100% reduction in MRTC counts at the week five follow-up visit. Percentage reductions were greater in the Dose 2 group than in the Dose 1 group at every follow-up visit. Correlation between the reduction in overall MRTC frequencies and the physical component of the MSIS (p=0.0086) was strong. There was a trend to improved EDSS (p=0.0561). The annual relapse rate (ARR) for the patients prior two years before therapy was 1.28 and following therapy the ARR was 0.10 (92 percent reduction) adjusted for the number of months in the study. The treatment appears to be safe and well tolerated with minimal adverse events and no dose-limiting toxicities.

"If myelin autoreactive T cells are the basis for MS, then we now appear to have a precision guided treatment to seek out and selectively suppress these T cells," said Brian D. Loftus, M.D., director of Neurology Research at the Diagnostic Clinic of Houston, principal investigator for PharmaFrontiers' two current Phase I/II clinical trials of Tovaxin, and co-author of the study who also presented at the meeting.

The presentation, "Autologous T Cell Therapy in Multiple Sclerosis: An Open Label Safety and Dose Range Study," is authored by Dr. Loftus, Mitzi Montgomery, DVM, Ph.D., PharmaFrontiers vice president of Preclinical Development, and Dr. Williams.

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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21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis
10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis
http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=12064&XNSPRACHE_ID=2&XNKONGRESS_ID=22&XNMASKEN_ID=900
Therapy - immunomodulation - Part II
Friday, September 30, 2005, 15:30 - 17:00
Autologous T cell therapy in multiple sclerosis: an open-label safety and dose-range study
B. Loftus, M. Montgomery, J. Williams (The Woodlands, USA)

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Objective: To evaluate the safety of a trivalent autologous T cell therapy (TCT) (Tovaxin™) and the effective dose to deplete myelin peptide-reactive T cells (MRTCs) in Multiple Sclerosis. Background: MRTCs play a critical role in the pathogenesis of MS. Previous TCT pilot studies used a monovalent formulation of attenuated MRTCs to deplete myelin basic protein (MBP) reactive T cells. Because several myelin antigens are described as potential autoantigens for MS, depletion of MRTCs using a trivalent formulation (TF) may have enhanced therapeutic effects.
Design/Methods: Patients with relapsing remitting- or secondary progressive-MS intolerant of or having failed current therapy donated blood from which T cells reactive to two peptides each of three proteins [MBP, proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG)] were expanded ex vivo and prepared as a TF of CD4+ and CD8+ MRTCs. The MRTCs were attenuated by Cesium137 irradiation prior to patients receiving subcutaneous injections of either 6-9 million cells (dose 1) or 30-45 million cells (dose 2) at weeks 0, 4, 12 and 20. MRTC frequencies were performed at baseline and weeks 5, 13, 21, 28 and 52. Patients were evaluated for changes in Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS) and exacerbations.
Results: MRTCs in the peripheral blood were depleted in a dose dependent manner and analyses showed reductions in all 3 types of MRTCs at all follow-up visits. All patients in the dose 2 group had a 100% reduction in MRTC counts at the week 5 follow-up visit. Percentage reductions were greater in the dose 2 group than in the dose 1 group at every follow-up visit. Correlation between the reduction in overall MRTC frequencies and the physical component of the MSIS (p=0.0086) was strong. There was a trend to improved EDSS (p=0.0561). One exacerbation was observed in the dose 1 group. The treatment appears to be safe and well tolerated with minimal adverse events and no dose-limiting toxicities.
Conclusion: MRTCs in patients with MS can be depleted by Tovaxin treatment. MSIS and EDSS clinical measures are improved and the treatment appears safe and well tolerated. A Phase IIb double-blind placebo-controlled trial to study the effects of Tovaxin in treatment of early relapsing MS patients is being planned.

Posted by: Tim at Oct 21, 2005 7:18:21 PM

how does one find out about taking the vaccine? my son has MS

Posted by: any longoria at Oct 11, 2005 9:37:39 PM

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.
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20050810005158&newsLang=en

Posted by: Tim at Aug 15, 2005 5:39:58 AM

If you would like to learn more about Tovaxin, please visit http://www.timswellness.com I am in the current FDA clinical trial, and this is how I am doing. Tim

Posted by: Tim at Aug 13, 2005 8:46:09 PM

If you would like to learn more about Tovaxin, please visit http://www.ihavems.com I am in the current FDA clinical trial, and this is how I am doing. Tim

Posted by: Tim at Jun 12, 2005 9:03:49 AM