Trial Outcomes & Findings for Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis (NCT NCT00595920)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

Annually

Results posted on

2016-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	116
Overall Study Patients Dosed	38
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	116

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study The OLTERMS study was discontinued by th	116

Baseline Characteristics

Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Extension n=38 Participants 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.
Age, Continuous	39.98 years n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	26 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	38 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Annually

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Annually

Outcome measures

Outcome data not reported

Adverse Events

Open Label Extension

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open Label Extension n=38 participants at risk 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.
Immune system disorders Multiple Sclerosis Relapse	2.6% 1/38 • Number of events 1

Other adverse events

Other adverse events
Measure	Open Label Extension n=38 participants at risk 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.
General disorders Injection site reaction-Bruising	28.9% 11/38 • Number of events 11
General disorders Injection site reaction-Disomfort	18.4% 7/38 • Number of events 7
General disorders Injection site reaction-Induration	13.2% 5/38 • Number of events 5
General disorders Injection site reaction-Redness	63.2% 24/38 • Number of events 24
Gastrointestinal disorders Injection site reaction-Swelling	21.1% 8/38 • Number of events 8

Additional Information

Kenny Frazier, VP of Clinical Development and Regulatory Affairs

Opexa Therapeutics, Inc.

Phone: 281-775-0660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60