Technology Listings


Progesterone to Treat Traumatic Brain Injury

Application

The use of progesterone to treat patients with traumatic brain injury (TBI) via a tapered administration protocol.

Key Benefits
  • Early administration of progesterone reduces cerebral edema and neural loss, and improves behavioral recovery from traumatic brain injury (TBI) in pre-clinical animal models.
  • Tapered progesterone withdrawal enhances recovery after TBI compared to acute withdrawal.
  • Progesterone reduces mortality by 50% and improves functional outcomes in patients with TBI in phase II clinical trials.
  • Tested in phase II and phase III clinical trials and has an acceptable safety profile.
Market Summary

More than 2.5 million emergency room visits, hospitalizations, or deaths are associated with traumatic brain injury (TBI) each year in the United States alone. TBI in children under 18 results in 7400 deaths and more than 60,000 hospitalizations. The majority of these hospitalized children are discharged with a permanent disability from a TBI. Currently only maintenance therapy is done for these patients, including monitoring and maintaining blood pressure, oxygenation and intracranial pressure, infection prophylaxis, and deep vein thrombosis prophylaxis. More than 30 clinical trials have investigated various compounds for the treatment of acute TBI, but no treatment has shown efficacy in these trials. There is still no effective pharmacotherapy for TBI.

Technical Summary

Progesterone has been shown to have various functions in neuroprotection, including inhibition of inflammatory cytokines, apoptosis reduction, excitotoxicity prevention, and control of vasogenic edema, in multiple animal models. Emory researchers have found that the use of progesterone to treat traumatic brain injury could improve outcomes for patients suffering from TBI. The inventors designed a method of progesterone administration via IV infusion with an initial high dose, several days of a lower dose, and then a tapered withdrawal. This method can allow quick drug delivery and achieve a constant and therapeutically effective serum concentration of progesterone. Administration of progesterone decreased mortality and improved functional outcomes in patients with TBI in two single-center clinical trials.

Development Stage

Failed to show efficacy in two randomized, double-blind, placebo-controlled phase III clinical trials, but may be effective in more homogeneous patient population following dose-optimization and duration of treatment in a more focused Phase 2B trial using more quantitative primary measures of functional outcomes.

Patent Information
App Type Country Serial No. Patent No. File Date Issued Date Expire Date
Nationalized PCT - Foreign EP 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
Nationalized PCT - Foreign Japan 2008-503262 5394059 3/24/2006 10/25/2013 3/24/2026
Nationalized PCT - Foreign Australia 2006226774 2006226774 3/24/2006 3/27/2011 3/24/2026
Nationalized PCT - Foreign Canada 2,602,950 2,602,950 3/24/2006 10/30/2012 3/24/2026
Nationalized - Based on Foreign IP Hong Kong 08107230.7 HK 1112581 3/24/2006 11/25/2011 3/24/2026
Divisional EP 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
EP Registered Country France 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
EP Registered Country Germany 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
EP Registered Country Italy 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
EP Registered Country Spain 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
EP Registered Country Switzerland 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
EP Registered Country United Kingdom 06739662.2 1871382 3/24/2006 8/17/2011 3/24/2026
Continuation United States 13/550,148 8,614,203 3/24/2006 12/24/2013 3/24/2026
EP Registered Country France 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
EP Registered Country Germany 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
EP Registered Country Italy 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
EP Registered Country Spain 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
EP Registered Country Switzerland 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
EP Registered Country United Kingdom 11177154.9 2431042 3/24/2006 6/26/2013 3/24/2026
Tech ID: NCS.15
Published: 6/1/2015
Category
Therapeutics

Contact
Justin Burns
Licensing Associate
Emory University
justin.burns@emory.edu

Inventor(s)
Donald Stein
Stuart Hoffman
Arthur Kellermann
David Wright
Douglas Lowery
Sarah Cutler

Keywords
Accident and Trauma
Neuroscience/Pain