Opexa Reports Positive Safety Results From Phase I/II Multiple Sclerosis Study
Posted on: Friday, 13 June 2008, 09:00 CDT
Opexa Therapeutics has announced favorable safety and efficacy data for Tovaxin, the company's investigational T-cell vaccination therapy for multiple sclerosis, in the second year of open-label clinical retreatment studies in patients with multiple sclerosis.
The 'intent to treat' population of 22 patients included 13 with relapsing remitting multiple sclerosis (RRMS) and nine with secondary progressive multiple sclerosis (SPMS). An analysis of disease progression of disability over a two year period, as measured by a 1.0 or greater change in expanded disability scoring scale (EDSS), showed that 27.3% of patients demonstrated sustained improvement, 59.1% had no disease progression and 13.6% experienced sustained worsening of disability. The improvement in the EDSS scores ranged from 1.0 to 4.5 (average 2.41). During the two-year study period 72.7% of patients remained relapse-free.
The annualized relapse rate analysis of 17 patients (which excludes five patients with no prior relapses in their two-year pre-study baseline) showed Tovaxin therapy achieved an 82% reduction in annualized relapse rate (ARR) in patients over a two-year period (p<0.0001) to 0.21 relapses per year, compared with 1.38 relapses per year in the patients's prior two-year baseline.
For RRMS patients (n=12) the ARR over a two-year period was 0.26 relapses per year, compared with 1.63 relapses per year in the patients's prior two-year baseline; for SPMS patients (n=5) the ARR over a two-year period was 0.10 relapses per year, compared with 0.80 relapses per year in the patients's prior two-year baseline.
The combined analysis included patients participating in second-year extension protocols from the Phase I/II dose-escalation study and the Phase I/II re-treatment study, and 19 of 22 patients were re-treated with Tovaxin during the study period. Patients did not receive any other disease modifying therapies during the two-year study period.
Tovaxin was well-tolerated throughout the two-year study period. The safety profile revealed only mild-to-moderate injection site reactions and no serious adverse reactions related to T-cell vaccination.
Source: Datamonitor
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