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

Article

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

This article was originally published on the Specialty Pharmacy Times website.

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.

Click here to access the full-text version of this article on the Specialty Pharmacy Times website.

Recent Videos
Matthew Ku, MBBS, FRACP, RACP, FRCPA/RCPA, PhD, an associate professor and the lymphoma stream lead at St Vincent’s Hospital
Saurabh Dahiya, MD, FACP, an associate professor of medicine at Stanford University School of Medicine; as well as clinical director of Cancer Cell Therapy in the Division of Blood and Marrow Transplantation and Cell Therapy at Stanford Medicine
Shahzad Raza, MD, a hematologist/oncologist at the Cleveland Clinic
Manali Kamdar, MD, the associate professor of medicine–hematology and clinical director of lymphoma services at the University of Colorado
Shahzad Raza, MD, a hematologist/oncologist at the Cleveland Clinic
Laura Aguilar MD, PhD, the chief medical officer of Diakonos Oncology
Jamie Jacobs, PhD, the program director of the center for psychiatric oncology & behavioral sciences at Mass General Cancer Center
Laura Aguilar MD, PhD, the chief medical officer of Diakonos Oncology
Sarah Hein, PhD, the chief executive officer and cofounder of March Biosciences
Brian Kim, MBA, the chief executive officer of Mission Bio
Related Content
© 2025 MJH Life Sciences

All rights reserved.