Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effects of the investigational drug, SB-509 on progression of the disease in subjects with ALS

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sangamo Biosciences; Sangamo Therapeutics

Criteria

Inclusion Criteria:

• Male or female between the ages of 18 and 85 with clinical diagnosis of ALS

• Forced Vital Capacity (FVC) > 60% of predicted

• Less than 3 years of ALS since the onset of the first symptom with clinical evidence of limb muscle atrophy and weakness.

• Subjects taking Riluzole must have been at a stable dose for at least 30 days with no evidence of toxicity

• Female of childbearing potential and male of child-creating potential must agree to use a medically acceptable physical barrier (condom, diaphragm, and cervical cap) through the treatment phase and for at least 30 days after the last study treatment.

Exclusion Criteria:

• Women who are pregnant or currently breast-feeding

• Dependent upon invasive or non-invasive artificial ventilation

• Patients with bulbar onset ALS or with other active neuromuscular/ neurodegenerative diseases.

• Type 1 or Type 2 diabetes.

• Evidence of chronic or active heart, liver, kidney, or lung diseases, or Age-related macular degeneration.

• Current or history of known immune or immunodeficiency disorders

• Patients with cognitive impairment with significant decision making incapacity, or major depression, or schizophrenia, or dementia (e.g. Alzheimer's disease).

• Malignancy or history of malignancy, except it has been in complete remission for at least 5 years

• Pre-cancerous conditions (e.g. Barrett's Esophagus, dysplasias) or benign tumors which have the potential for significant growth due to VEGF stimulation.