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Financial Constraints
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The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tovaxin, open-label | Experimental | Tovaxin; 30-45 million autologous myelin reactive T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tovaxin | Biological | 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) | This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data. | Annually |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression | Annually | |
| Evaluate Changes in Annualized Relapse Rate | Annually |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward J Fox, MD, PhD | Central Texas Neurology Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates, PC | Cullman | Alabama | 35058 | United States | ||
| Xenoscience - 21st Century Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11642613 | Background | Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55. | |
| 11985389 | Background | Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Extension | 30-45 million autologous myelin reactive T cells Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| 85013 |
| United States |
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States |
| Alta Bates Summit Medical Center - East Bay Physicians Medical Group | Berkeley | California | 94705 | United States |
| Patricia A Fodor, PC | Colorado Springs | Colorado | 80919 | United States |
| Bradenton Neurology | Bradenton | Florida | 34205 | United States |
| Neurological Associates | Pompano Beach | Florida | 33060 | United States |
| Medical College of Georgia - Department of Neurology | Augusta | Georgia | 30912 | United States |
| Consultants in Neurology, Ltd. | Northbrook | Illinois | 60062 | United States |
| Allied Physicians Inc | Fort Wayne | Indiana | 46805 | United States |
| MidAmerica Neuroscience Institute | Lenexa | Kansas | 66214 | United States |
| Associates in Neurology | Lexington | Kentucky | 40503 | United States |
| St Mary's of Michigan - Field Neuroscience Institute | Saginaw | Michigan | 48604 | United States |
| Ayres & Associates Clinical Trials | Lebanon | New Hampshire | 03766 | United States |
| Upstate Clinical Research, LLC | Albany | New York | 12205 | United States |
| Winthrop University Hospital - Clinical Trials Unit | Mineola | New York | 11501 | United States |
| Neurology Consultants of the Carolinas, PA | Charlotte | North Carolina | 28204 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Neurology & Neuroscience Associates, Inc. | Akron | Ohio | 44302 | United States |
| Neurological Research Institute | Columbus | Ohio | 43221 | United States |
| Neurology Specialists, Inc | Dayton | Ohio | 45408 | United States |
| Providence St. Vincent Medical Center - Northwest MS Center | Portland | Oregon | 97225 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The Maxine Mesinger MS Clinic/Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Central Texas Neurology | Round Rock | Texas | 78681 | United States |
| Integra Clinical Research, LLC | San Antonio | Texas | 78229 | United States |
| MS Center at Evergreen | Kirkland | Washington | 98101 | United States |
| 12901569 | Background | Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285. |
| Patients Dosed |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Randomized and received at least one dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Extension | 30-45 million autologous myelin reactive T cells Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) | This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data. | This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up. | Posted | Annually |
|
| |||||||||||||||||||
| Secondary | Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression | Not Posted | Annually | |||||||||||||||||||||||
| Secondary | Evaluate Changes in Annualized Relapse Rate | Not Posted | Annually |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Extension | 30-45 million autologous myelin reactive T cells Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required. | 1 | 38 | 25 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Sclerosis Relapse | Immune system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction-Bruising | General disorders | Systematic Assessment |
| ||
| Injection site reaction-Disomfort | General disorders | Systematic Assessment |
| ||
| Injection site reaction-Induration | General disorders | Systematic Assessment |
| ||
| Injection site reaction-Redness | General disorders | Systematic Assessment |
| ||
| Injection site reaction-Swelling | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenny Frazier, VP of Clinical Development and Regulatory Affairs | Opexa Therapeutics, Inc. | 281-775-0660 | kfrazier@opexatherapeutics.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C540587 | tovaxin |
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| >=65 years |
|