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By Catherine Hollingsworth
Staff Writer
Shares of Opexa Therapeutics Inc. soared 270 percent Tuesday on news of a positive complete analysis of its Phase IIb drug for multiple sclerosis, Tovaxin.
It was a big turnaround from a year ago, when the first Phase IIb study of Tovaxin missed its primary goal of reducing the number of brain lesions in early relapsing MS, causing Opexa shares to lose 90 percent of their value at the time.
Woodlands, Texas-based Opexa saw much better results in its extended analysis of the exploratory Phase IIb trial, known as TERMS (Tovaxin for Early Relapsing Multiple Sclerosis).
The complete analysis of TERMS showed that more than 83 percent of the Tovaxin-treated group remained relapse-free at one year.
Opexa CEO Neil Warma called the findings "quite encouraging," and noted that the relapse rates analyzed in the trial were at the lowest range seen with marketed products.
The annualized relapse rate after treatment decreased to 0.20, a 42 percent reduction compared to placebo, according to the analysis.
The analysis evaluated patients with an annualized relapse rate of one or greater at study entry, a more traditional patient population, Warma explained. Patients in the analysis represent 86 percent of the total patient population in the Phase IIb TERMS study.
Along with a marked reduction in relapses, 16.5 percent of Tovaxin-treated patients showed a sustained improvement in disability.
On magnetic resonance imaging, the Tovaxin-treated group also demonstrated a reduction in brain atrophy and fewer inflammatory brain lesions that progressed to "black holes," as compared to the placebo-treated group.
In addition, treatment with Tovaxin was well tolerated, with no serious adverse events reported in any Tovaxin-treated patient.
"The expanded analysis represents the MS patient population with active relapsing-remitting disease planned for recruitment into the next Phase IIb trial of Tovaxin," Dawn McGuire, a board-certified neurologist and a member of Opexa's clinical advisory board, said in a statement. She added that the results "raise the possibility that Tovaxin-treatment may have neuroprotective as well as disease-modifying effects."
Data from an earlier analysis of the TERMS trials also were positive.
In March, Opexa found that in the complete modified intent-to-treat population (142 patients), multiple sclerosis patients treated with Tovaxin demonstrated a statistically significant improvement in scores for the impact of visual impairment compared to those on placebo. That improvement was observed within six months of completing the full course of treatment.
The company hopes to start a second, confirmatory Phase IIb trial in the first half of 2010.
While Opexa is considering a possible financing to raise additional funds for that trial, "the preferred path is to secure an experienced partner," Warma told BioWorld Today. Potential partner discussions are "progressing well," he said.
The company's current cash resources will be supplemented by the $4 million it received from Swiss drugmaker Novartis AG under a recently announced stem cell agreement, Donna Rill, senior vice president of operations, told BioWorld Today.
Under the stem cell deal, Novartis will acquire the stem cell technology and take full responsibility for funding and carrying out all research, development and commercialization activities.
In exchange, Opexa will receive an up-front cash payment of $3 million, plus an additional $1 million as a technology transfer fee to be paid over a six-month period.
Total payments to Opexa, including the up-front payment, the technology transfer fee and milestone payments, could exceed $50 million, not including royalties. (See BioWorld Today, Aug. 10, 2009.)
Shares in Opexa (NASDAQ:OPEX) were up $4.13 Tuesday, closing at $5.66. | 
