Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna
, a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today announced that the Company has been featured in
. The article, titled "
Regulation May Be Impaired in Patients With Secondary Progressive MS,”
was written by Erik Greb, the publication's senior associate editor, and presents data from Opexa’s Immune Monitoring program that is part of its ongoing Phase IIb Abili-T trial in Secondary Progressive MS (SPMS).
The article presents baseline data on Opexa’s Immune Monitoring Program that was previously presented at the 2013 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) meeting. The immune monitoring data will be used to assess the impact of Tcelna in SPMS patients compared to patients receiving placebo. Opexa’s data supports the finding that immune regulation appears to be impaired in individuals with SPMS. Opexa characterized the status of patients with SPMS entering the Phase IIb trial at baseline and compared the data sets to those of healthy donors. The results showed a marked difference between key biomarkers of inflammation, specifically TR1 and Treg cells, in patients suffering from SPMS versus healthy donors. The results corroborated findings in the literature and provide support for the assays being utilized by Opexa for the immune monitoring program.
“As part of our Phase IIb Abili-T trial, we are undertaking a comprehensive immune monitoring program for all patients enrolled in the study,” commented Donald Healey, PhD, Chief Scientific Officer at Opexa. “The goals of this program are to further understand the biology behind the mechanism of action for Tcelna and to possibly identify novel biomarkers that are dominant in the pathophysiology of SPMS patients. The program encompasses an analysis of various pro-inflammatory and anti-inflammatory biomarkers. We believe that the blinded data, which will be analyzed during the course of the trial, may potentially signal responders and non-responders when correlated with clinical data on completion of the Abili-T study.”