Protalix Gains on "Positive" Phase II Results

Protalix Biotherapeutics Inc (NYSE: PLX) got the trading year off to a flying start, after the company disclosed 'positive' interim data from Phase II clinical trial of OPRX-106 in patients with ulcerative colitis.

The Israeli-based company said the phase II clinical trial is a randomized, open label, two-arm study of OPRX-106 in patients with active mild to moderate ulcerative colitis. A total of 24 patients were enrolled and randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for eight weeks.

The first 14 patients have completed the study, and four patients are currently in treatment and follow-up. The trial evaluated key efficacy endpoints including clinical response and remission utilizing the Mayo score, as well as safety and pharmacokinetics.

Data generated from the first 14 patients who completed the study demonstrates that 57% of the patients achieved clinical response and 36% achieved clinical remission at week eight.

In the rectal bleeding analysis, a sub category of the Mayo score, 79% of those patients show an improvement.

OPRX-106 is the Company’s novel proprietary plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain. When administered orally and while passing through the digestive tract, the plant cells function as a natural delivery capsule, having the unique attribute of a cellulose cell wall, which makes them resistant to degradation compared to proteins produced via mammalian cell expression systems.

Shares in the company gained three cents, or 4.4%, to 69 cents.