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Thursday, August 22, 2013

MS Trial Alert: Abili-T Study of Tcelna Immunotherapy Recruiting 180 People with Secondary-Progressive MS in U.S. and Canada

Aug 12, 2013

Summary: Investigators in the United States and Canada are recruiting 180 people with secondary-progressive MS for a phase 2 clinical trial of Tcelna® (Imilecleucel-T, Opexa Therapeutics, Inc.), a personalized T-cell therapy using an individual’s own immune cells.  The placebo-controlled study, also called the Abili-T study, is sponsored by Opexa Therapeutics, Inc., of The Woodlands, Texas.
Rationale: Tcelna is a personalized T-cell immunotherapy that aims to restore function to the immune system, which attacks nerve-insulating myelin in the brain and spinal cord in MS. Tcelna is tailored to each person’s immune response to myelin, and has been shown to reduce the number and/or functional activity of subsets of myelin-reactive T cells.(Clinical Immunology 2009;131:202-15)
Previously, a one-year, multi-center trial of Tcelna (formerly called “Tovaxin”) was conducted in 140 people with relapsing-remitting MS and 10 people who had experienced a neurological episode that put them at possible risk for being diagnosed with MS. The TERMS study found Tcelna to be safe (Multiple Sclerosis, 2012;18:843).   
Tcelna has been designated by the U.S. Food and Drug Administration as a “Fast Track Product” for the treatment of secondary-progressive MS. The Fast Track designation may expedite its future review by the FDA after the company submits results of future phase III trials.
Eligibility and Details: Participants should be aged 18 to 60, diagnosed with secondary-progressive MS (defined as relapsing-remitting MS with recent progression in neurologic deficits independent of relapses in the previous two years). A blood test that confirms the presence of myelin reactive T-cells must be performed at the first screening visit. Further details on inclusion and exclusion criteria are available from the contacts below.
Cells are taken via a blood sample, a process similar to donating blood. Then participants are being randomly assigned to receive five injections given under the skin each year for two years, of either Tcelna or placebo. Neurologic and cognitive evaluations are being performed every 3 months, and imaging scans are being performed once each year. The primary objective of the study is to determine the effectiveness of this experimental treatment at reducing brain tissue volume loss. Other outcomes being assessed include relapse rate, disease activity on MRI scans, cognitive function, and quality of life.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you. Contact information is included in the study’s listing on clinicaltrials.gov. Or, contact Maryann Murray, (281) 719-3405, mmurray@opexatherapeutics.com, for further information.
Sites are enrolling in the following cities:
Phoenix, Arizona
Tucson, Arizona
Berkeley, California
Naples, Florida
Orlando, Florida
Vero Beach, Florida
Atlanta, Georgia
Indianapolis, Indiana
Kansas City, Kansas
Lexington, Kentucky
Boston, Massachusetts
Plainview, New York
Stony Brook, New York
Charlotte, North Carolina
Dayton, Ohio
Medford, Oregon
Portland, Oregon
Philadelphia, Pennsylvania
Houston, Texas
Round Rock, Texas
San Antonio, Texas
Burlington, Vermont
Newport News, Virginia
Issaquah, Washington
Seattle, Washington
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
 
Tcelna is a trademark of Opexa Therapeutics, Inc.

Source for this article: http://nationalmssociety.org/news/news-detail/index.aspx?nid=8098

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