Q Therapeutics has a deep pipeline, with significant market potential backed by a strong intellectual property position
Q Therapeutics is actively preparing for a first-in-human clinical trial in amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) as an orphan drug. Trial start-up is expected in 2015.
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
- Market exclusivity.
Existing safety and manufacturing data may also support Investigational New Drug (IND) filings for transverse myelitis, multiple sclerosis and spinal cord injury, providing significant cost and time savings for each additional indication.
Q Therapeutics’ patent estate, which consists of 21 issued patents and additional U.S. and international patents pending, provides a strong intellectual property position for Q-Cells®, as well as other neural lineage cells. Q Therapeutics has exclusive worldwide rights to our Q-Cells® product through an agreement with the University of Utah Research Foundation and through owned, internally-developed intellectual property.
Our patent portfolio encompasses five families of neural lineage progenitor or stem cell technologies. Currently, our patent estate encompasses composition of matter, methods of production and methods of use for multiple cell types of the central nervous system (including Q-Cells®), as well as some cell types of the peripheral nervous system.
ALS Clinical Trial
If you are inquiring about our ALS clinical trial, patient enrollment will not begin for several months. All clinical trial information and updates on trial status will be posted to www.clinicaltrials.gov
as they become available.