October 24, 2008
Opexa Reports Additional Positive Data From Phase IIb Multiple Sclerosis Study
Opexa Therapeutics, a biopharmaceutical company, has announced additional positive data from the company's Phase IIb clinical trial for the treatment of multiple sclerosis.
The latest analysis focused on a prospective group of patients (n=50) with an annualized relapse rate (ARR) of greater than one at study entry which is comparable to ARR baselines of patients in previous Tovaxin studies. These findings demonstrate a statistically significant improvement in disability as measured by the expanded disability status scale (EDSS) (p=0.045) for patients treated with Tovaxin as compared to those receiving placebo. In this group, 28.1% of patients treated with Tovaxin showed an improvement in EDSS as compared to only 5.6% in the placebo group.
Additionally, there was an 88% reduction in the level of brain atrophy and a more than 20% reduction in the number of gadolinium lesions progressing to black holes in the Tovaxin group, which may suggest a beneficial neuroprotective effect.
Overall, the analysis showed that patients treated with Tovaxin demonstrated a benefit across all clinical and magnetic resonance imaging endpoints in this patient population. Immunology data also appears to support Tovaxin's mechanism of action, indicating that patients with less myelin T-cell reactivity have a lower risk of relapse. Additional quality of life measurements, such as the timed 25 foot walk, also showed a benefit for Tovaxin over placebo (0.14 versus -0.02, as measured by respective Z scores).
The data showed that these patients when treated with Tovaxin demonstrate an ARR of 0.28 which represents a 55% reduction compared to those patients on placebo. This relapse rate is on par with the lowest relapse rates observed with currently available multiple sclerosis treatments which range from 0.2 to 0.9, said Opexa. Study findings also showed that Tovaxin possesses an impressive safety and tolerability profile.
Opexa expects to conduct a Phase II close-out meeting with the FDA during the first half of 2009 to discuss next steps for the further clinical development of Tovaxin. Opexa said that it is actively engaged in discussions with potential strategic partners for the Tovaxin program.
Neil Warma, president and CEO of Opexa, said: "This landmark first-in-class study has yielded impressive results for Tovaxin in multiple sclerosis patients with high disease burden, including a marked reduction in disability, relapse risk and levels of T-cell reactivity. These findings are very encouraging and we are eager to continue the clinical development of this novel therapeutic."