Woodlands-based Opexa Therapeutics recently announced that the company has completed enrollment for its clinical trial for Tcelna, a novel, personalized T-cell immunotherapy for treating Secondary Progressive Multiple Sclerosis.
180 patients have been enrolled in the Phase Ilb “Abili-T” clinical study for Tcelna, and will be randomly chosen to receive either the treatment or a placebo. For patients who are still currently in the screening process for the trial, they will also have an opportunity to enroll as well, provided they meet the trial’s entry criteria.
“Interest from physicians and patients to participate in the study was high, underscoring the need for innovative treatments for Secondary Progressive MS, an area of high unmet medical need,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “This is an important milestone for Opexa as we continue to work towards developing patient-specific immunotherapies for the treatment of Multiple Sclerosis.”
Edward Fox, Ph.D, is one of the neurologists that is working in the Abili-T trial, and believes the clinical study could be a step towards marked improvements for treating Secondary Progressive MS, since there are few treatment options for patients. “Achieving this significant milestone provides hope for this group and all individuals with MS,” he said.
The Abili-T trial is a Ilb phase of Tcelna that will study patients with secondary progressive multiple sclerosis in 35 clinical sites across the U.S. and Canada. Patients will receive two annual courses of Tcelna treatment with five subcutaneous injections per year.
Abili-T will be conducted as a randomized, double-blind, placebo-controlled clinical trial. Investigators will also measure several variables commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale, annualized relapse rate, and changes in disability as measured by EDSS and the MS Functional Composite.
The first results in previous studies revealed that the percentage of brain volume atrophy changed at 24 months. The results of the second phase of the research are expected in mid-2016.
At the beginning of last year, Opexa partnered with Merck Serono, a multinational company focused on treatment of MS, to discuss options and licenses for Tcelna. The agreement between the companies stated that Opexa could receive up to $220 million in goal payments and 8 to 15 percent in royalties.
Tcelna is excepted to be a personalized therapy customized to each patient’s disease profile. Opexa is conducting ongoing research in order to improve the production of patients’ specific T-cell immunotherapy, which encompasses specific blood features from patients.
Multiple Sclerosis is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide.