NEUROINFLAMMATORY PROCESSES IMPLICATED IN THE INITIATION AND PROGRESSION OF DISEASE
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease, affects as many as 30,000 people in the U.S., with an estimated 5,000 new cases diagnosed each year.
It is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord resulting in loss of motor function and often paralysis and death.
Accumulating evidence suggests that neuroinflammatory processes are implicated in the initiation and progression of ALS. Pre-clinical research has also demonstrated an increase in microgliosis (the shifting of microglia from a neuroprotective to a chronic, pro-inflammatory state) before the onset of ALS symptoms.
In a pre-clinical ALS (SOD1) model, we demonstrated that our proprietary formulation of cromolyn sodium (ALZT-OP1a):
We are currently evaluating the safety and efficacy of ALZT-OP1a in a Phase 2a randomized, open-label, multi-center, multi-dose clinical trial in subjects with mild to moderate-stage ALS. The study is listed at both clinicaltrials.gov and NEALS. (See Pipeline for more on the clinical development of ALZT-OP1a.)
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