Opexa completes patient enrolment for Phase IIb trial of Tcelna

14th May 2014 (Last Updated May 14th, 2014 18:30)

US-based biotechnology firm Opexa Therapeutics has completed patient enrolment in its Phase IIb clinical trial of Tcelna (imilecleucel-T), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS).

Relapsing Multiple Sclerosis

US-based biotechnology firm Opexa Therapeutics has completed patient enrolment in its Phase IIb clinical trial of Tcelna (imilecleucel-T), a novel T-cell immunotherapy for treatment of multiple sclerosis (MS).

A total of 180 patients with Secondary Progressive MS have been randomised in the Phase IIb 'Abili-T' trial.

The company said that it will also allow patients who are currently in the screening process at the time of full enrolment and who meet the trial's entry criteria to also be enrolled in the trial.

Opexa president and chief executive officer Neil Warma said interest from physicians and patients to participate in the trial was high, underscoring the need for innovative treatments for secondary progressive MS, an area of high unmet medical need.

"This is an important milestone for Opexa as we continue to work towards developing patient-specific immunotherapies for the treatment of multiple sclerosis," Warma said.

The completion of patient enrolment is supported by the clinical trial sites across the US and Canada.

Even though it has reached the full patient enrolment it required for the Abili-T trial, the company will continue to support those patients currently in the screening process.

"Achieving this significant milestone provides hope for all individuals with MS."

Abili-T trial one of the enrolling neurologists Edward Fox said that there are few treatment options for patients with secondary progressive MS.

"Achieving this significant milestone provides hope for this group and all individuals with MS," Fox said.

In the Phase IIb Abili-T trial, each patient is receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year.

Primary efficacy outcome of the trial is the percentage of brain volume change (atrophy) at 24 months, while its top line data is expected to be reported in mid-2016.

The company has received fast-track status from the US Food and Drug Administration (FDA) for Tcelna in secondary progressive multiple sclerosis.

In February 2013, the company had entered into an option and license agreement for Tcelna with Merck Serono, which is focused on the treatment of MS.


Image: Photomicrograph of a demyelinating multiple sclerosis-Lesion. Photo: courtesy of Marvin 101.