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New ALS drug headed for phase II trial at Methodist

Houston, TX - 10/25/2013

Houston Methodist Neurological Institute researchers will soon begin phase IIa clinical trials of TDI-132, a drug that in animal models has shown promise in reducing the inflammation associated with Amyotrophic Lateral Sclerosis, also known as ALS or Lou Gehrig's Disease.

The purpose of the phase IIa trial is to determine the safety and tolerability of TDI-132 in ALS patients. Individuals in the research group will receive .5 mg of TDI-132 each day for four weeks.

Not all ALS patients are eligible to participate. For eligibility requirements, please visit http://www.als.net/TDI-132.

"Our primary goal in this trial is to determine the safety of fingolimod in a small trial at four centers in the U.S., including our own MDA/ALS Center at Methodist," said Houston Methodist Neurological Institute Director Stanley Appel, M.D. "Prior studies in our animal model as well as in ALS patients indicate the potential therapeutic value of increasing protective T cells, and fingolimod -- an FDA-approved medication with significant benefit for Multiple Sclerosis patients -- may provide similar benefit for our ALS patients, and thus merits initial determination of safety."

ALS Clinical Research Division Director Ericka Simpson, M.D., is the site principal investigator of the study.

TDI-132 is also known as fingolimod, or by its commercial name, Gilenya, a drug originally developed by Novartis International to treat multiple sclerosis. Preclinical studies have shown TDI-132 can decrease the number of immune cells, keeping cells in lymph nodes from entering general circulation. These studies also indicate that decreases in the number of these cells can protect against inflammation and the worsening of symptoms.

The phase IIa trial is being funded by the ALS Therapy Development Institute (ALS TDI), a Cambridge, Mass.-based non-profit biotech.

"Seeing TDI-132 enter into clinical trial for ALS gives me hope that people living with ALS may soon be able to fight back," said Augie Nieto, an ALS patient and chair of the board at ALS TDI.

The principal investigator for the larger trial is James Berry, M.D., at Massachusetts General Hospital, also one of the study sites. The other two study sites are University of California, Irvine Healthcare in Orange, Calif., and Georgia Health Sciences University in Augusta, Ga.

Appel is the Peggy and Gary Edwards Distinguished Endowed Chair in ALS Research, chair of Department of Neurology at Houston Methodist Hospital, and is a Weill Cornell Medical College professor of neurology.

If you are a reporter and would like to speak with Dr. Ericka Simpson or Dr. Stanley Appel, please contact David Bricker, The Methodist Hospital System, at 832-667-5811 or dmbricker@houstonmethodist.org. To speak with Nieto or another representative of ALS TDI, please contact Mari Sullivan at 617-441-7220 or msullivan@als.net.