Massachusetts General Hospital

Phase II TDI 132 Trial Announced

14/Feb/2012

The ALS Therapy Development Institute (ALS TDI) and the Northeast ALS Consortium (NEALS) announced that they will launch a Phase II clinical trial investigating TDI 132, also known as Gilenya® or fingolimod, as a potential treatment for ALS.  Gilenya® is currently marketed by Novartis AG as an oral treatment for relapse-remitting multiple sclerosis.  Preclinical testing at ALS TDI showed that TDI 132 significantly alters the trafficking of certain immune cells through the bloodstream, resulting in fewer of them infiltrating into and damaging the nervous system.

This Phase II clinical trial will determine safety and tolerability of TDI 132 in patients with ALS.  It will yield important information on dosing and safety for a subsequent efficacy study.  NEALS is working with ALSTDI to design and conduct the clinical trial trial.
     
“We are thrilled to work with ALS TDI on this important Phase II trial in ALS,” said Merit Cudkowicz, M.D., Director of the Neurology Clinical Trials Unit at Massachusetts General Hospital, one of the principal investigators of the clinical trial.

Drs. James Berry and Steve Perrin will hold a webinar for the ALS community to review the scientific rationale for the Gilenya® trial and to describe the current clinical trial design. The webinar will take place on March 12th at 3pm Eastern Standard Time.

To watch the TDI 132 Informational Webinar, go here.

The announcement was featured in the Wall Street Journal.  Read it here.