Maryland-based biopharmaceutical company Seneca Biopharma (NASDAQ: SNCA) has provided an update on the planning of a phase 3 clinical trial of its cell therapy candidate NSI-566 for the treatment of Amyotrophic Lateral Sclerosis (ALS), Asia Impairment Score (AIS) Scale A complete chronic spinal cord injury (cSCI), and ischemic stroke.
After meeting with the United States Food and Drug Administration Office of Tissues and Advanced Therapies on March 10th, 2020, to “discuss future clinical development plans for NSI-566” for the treatment of ALS, Seneca Biopharma “believes that the existing phase 1 and 2 trial results support moving into a phase 3 clinical study for ALS.”
Seneca Biopharma’s Chief Medical Officer David Recker, MD, stated, “This represents a major step forward in getting our potentially beneficial therapy to patients who suffer from this devastating disease. We received significant guidance from FDA regarding an acceptable trial design and are in the process of developing the protocol for further review.”
Executive Chairman of Seneca Dr. Ken Carter commented, “We are very pleased with the outcome of the discussions. We look forward to working closely with the Agency on finalizing the design of a Phase 3 trial for this devastating disease.”
NSI-566, a neural stem cell line derived from the spinal cord, is currently designated as an orphan drug for the treatment of ALS, a rare progressive paralytic disorder and motor neuron disease that results in mortality from respiratory failure.
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Approximately 6,000 new cases of ALS are diagnosed in the United States every year, and as of 2018, the Centers for Disease Control and Prevention reported between 16,000 and 17,000 affected individuals.
The press release follows Seneca’s April 3rd announcement of the completion of a stem cell manufacturing facility in Suzhou, China, which will be used to produce NSI-566 for clinical trials in China.
“Completion of our new facility in Suzhou is a key milestone in Seneca’s product development strategy. This facility will allow us to manufacture cells to support our current and future clinical trials in China.” Further, Dr. Carter commented “I’d like to personally thank the staff who have been able to move forward on this plan while maintaining their safety during these uncertain times,” stated Dr. Carter.