Clinically Isolated Syndrome, Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Tovaxin, Autologous, T-cell vaccine (TCV)
Brief summary
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Detailed description
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.
Interventions
BIOLOGICALTovaxin
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
Sponsors
Opexa Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects who completed the TERMS study and received at least 1 study treatment injection * Signed and dated statement of informed consent
Exclusion criteria
* Pregnancy or breastfeeding * Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study. * Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments. * Non-compliant with TERMS study. * Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study. * Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study. * Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) | Annually | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate Changes in Annualized Relapse Rate | Annually |
| Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression | Annually |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | The OLTERMS study was discontinued by th | 116 |
Baseline characteristics
| Characteristic | Open Label Extension |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 39.98 years |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 38 |
| serious Total, serious adverse events | 1 / 38 |
Outcome results
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.
Time frame: Annually
Population: 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.
Secondary
Evaluate Changes in Annualized Relapse Rate
Time frame: Annually
Secondary
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Time frame: Annually