ALS Community Tells FDA ‘We Have No Time To Waste’; Urges Changes in Trial Design and Review Process

Because of the relentless effects of ALS, a diverse group of ALS voices — patients, families, organizations and the community — came together to speak about their experiences with ALS and to urge the FDA to work with them to overcome some of the obstacles faced in ALS research, clinical trials and standards of care.

ALS Clinical Trials: New Hope After Phase 3 Setbacks

“Some may look at recent failures and be discouraged,” wrote Richard Bedlack of the Duke ALS Clinic in Durham, North Carolina, in an e-mail to Alzforum. Thanks to advances in genetics and biomarkers, and a list of potential target pathways, “I think this is a time of unprecedented hope and excitement in ALS research”

Dr. Eva Feldman, Principal Investigator, Updates Interim Data On Completed Neuralstem ALS Phase I Trial

“With the transplantation of these neural stem cells, we are exploring a paradigm shift in the treatment of ALS. We have demonstrated that intraspinal transplantation is feasible and well-tolerated…”

ALS Patients Get New Diaphragm Pacer to Keep Lungs Breathing, Extend Life

Studies have shown patients who are “paced” live about 15 months longer than patients who don’t have the pacer, she said. And their lives are about nine months longer than patients who only have noninvasive ventilators.