Trial Initiated to Measure Efficacy of T-Cell Therapy in Secondary Progressive MS

Opexa Therapeutics is initiating a phase IIb trial of a novel therapy that targets T-cells in patients with secondary progressive multiple sclerosis.

On May 13, 2014, biotechnology company Opexa Therapeutics announced initiation of the Abili-T phase IIb trial evaluating the efficacy of a T-cell immunotherapy option Tcelna (imilecleucel-T) for treatment of patients with secondary progressive multiple sclerosis.

According to ClinicalTrials.gov, the double-blind, placebo-controlled, 180-patient trial will evaluate imilecleucel-T over a period of 2 years. During that time, investigators will evaluate the primary outcome of brain atrophy as measured by MRI measures and the secondary outcome of disease progression status.

In a press release, Chief Executive Officer of Opexa Neil K. Warma stated, “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.”

Although many treatments are available for patients with relapsing forms of MS, treatment of progressive forms of MS are currently limited to symptom management.

The 2-year study will be conducted at 35 clinical centers across the United States and Canada. Patients will receive 5 subcutaneous injections of imilecleucel-T over a 24-week period at a dose of 30 to 45 million cells per 2-mL injection.

Each 24-week course of therapy will be administered twice yearly. Results are expected in December 2015, although data collection and processing may delay publication of results until 2016.