HUMAN TRIALS IN PREPARATION
Q Therapeutics has a deep pipeline, with significant market potential backed by a strong intellectual property position.
Q Therapeutics is actively preparing for first-in-human clinical trials in transverse myelitis and amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) as an orphan drug. Trial start-up is expected in 2019.
Orphan drug designation has significant regulatory, financial and competitive advantages, including:
High rates of regulatory approval
Shorter development timelines including FDA Fast Track designation, and
Existing safety and manufacturing data may also support Investigational New Drug (IND) filings for spinal cord injury and multiple sclerosis and , providing significant cost and time savings for each additional indication.