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ALS TDI gets US FDA nod to conduct trial of TDI-132 in amyotrophic lateral sclerosis patients
Cambridge, Massachusetts | Wednesday, February 13, 2013, 10:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has granted approval to The ALS Therapy Development Institute (ALS TDI) to conduct a clinical trial of TDI-132 (fingolimod, Gilenya) in amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease). This clinical trial is being launched as a phase IIA with the primary purpose of determining the safety and tolerability of TDI-132/Gilenya in people with ALS.

Fingolimod is currently being marketed by Novartis AG as Gilenya as a treatment for some forms of multiple sclerosis.

“It was exciting to see how expeditious the FDA reviewed our application to test Gilenya in ALS patients,” comments Steve Perrin, PhD., CEO and CSO of ALS TDI. “We are eager to start enrolling patients in the clinical trial of TDI-132 and take this important step toward understanding whether or not Gilenya is a potential treatment for ALS.”

“Seeing TDI-132 enter into clinical trial for ALS gives me hope that people living with ALS may soon be able to fight back,” says Augie Nieto, an ALS patient and chairman of the board at ALS TDI. Nieto, through his involvement as head of the Muscular Dystrophy Association’s “Augie’s Quest,” has contributed greatly in funding the research leading to the advancement of this clinical trial.

ALS TDI researchers first began preclinical testing of TDI-132 in 2011 for its ability to block certain immune cells from entering the brain and spinal cord where they can cause activities that result in damage to motor neurons. The Institute has confirmed that TDI-132 significantly reduces the circulation of these immune cells through the bloodstream, resulting in fewer of them infiltrating into the central nervous system. Further experiments at ALS TDI showed treatment with TDI-132 resulted in positive outcome based on several disease measures in preclinical studies. In February 2012, the Institute officially announced TDI-132 as a clinical candidate.

ALS TDI worked with the Northeast ALS Consortium (NEALS) on the clinical trial design. NEALS will oversee the execution of the clinical trial.

Amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease) is a progressive neurodegenerative disease that leads to paralysis, due to the death of motor neurons in the spinal cord and brain. There is no known cure for the disease.

The mission of the ALS Therapy Development Institute (ALS TDI) is to develop effective therapeutics that slow or stop ALS or Lou Gehrig’s disease as soon as possible for patients today. Focused on meeting this urgent unmet medical need, ALS TDI executes a robust target discovery program, while simultaneously operating the world’s largest efforts to preclinically validate potential therapeutics; including a pipeline of dozens of small molecules, protein biologics, gene therapies and cell-based constructs.

Comments

darlene eck Feb 14, 2013 11:24 PM
It's time the FDA start loosening up on getting the USA in the frontline on disease. ALS is fast and has no mercy, they can't wait for the FDA to sit around and play God. Get over it FDA and let research begin. Don't you know all the other countries are saying that the USA is behind because of YOU. What if your loved one had ALS< I guess you would think again or would you not???
and Peggy Sue Cline Farni get out there and get something done, I need you really bad. :(
Giselle Buchanan Feb 14, 2013 7:08 PM
Will Canadian patients be able to participate?
jerry fouts Feb 14, 2013 7:31 AM
how many and where just finished rasgiline drug trial and waiting for another at ku med cntr drug trial clinic
Ron Schaffer Feb 14, 2013 4:24 AM
What's the cut off from diagnoses date?
darlene eck Feb 14, 2013 4:10 AM
get my sister in thie program, she has ALS. sign her up, her name is peggy sue cline farni, canute, ok
580-2433536

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