Traumatic Brain Injury
The company estimates that there are approximately 1.4 million incidences of Traumatic Brain Injury (TBI) in the United States each year. Of those, approximately 300,000 cases would be classified as severe. TBI is the #1 cause of disability among those under age 35.
TBI leads to 99,000 cases of lasting disability annually. Fifty percent of survivors suffer major impairment.
We believe that OXYCYTE could help in 200,000 of the severe cases and significantly reduce the lasting disability cases.
Another important cause of TBI is Military Blast Injury. There were an estimated 360,000 such incidences among American military personnel from 2002-2008.
-TBI is the largest killer in the war on terror, due to roadside bombs.
-50% of the survivors of severe TBI have major impairments.
-No effective medical treatments are available.
Based on the promise of OXYCYTE in treating TBI, we have an obligation to evaluate a potentially beneficial therapeutic intervention.
On August 13, 2009, the company received approval from Swissmedic to conduct a Phase II, dose escalation, clinical trial in Switzerland using OXYCYTE in traumatic brain injury. It is a randomized, controlled, double-blind, dose escalation Phase II study to assess Safety and Tolerability. The company has named the study “Safety and Tolerability of OXYCYTE in Patients with Traumatic Brain Injury” or “STOP TBI”.
The first patient is expected to be enrolled in November 2009. Since study participants will all be emergency cases, it is not possible to pinpoint a date for the actual first patient.
Patients in the test arm will receive a single infusion of one of three incremental doses of OXYCYTE to be given within 12 hours of injury along with 50% Oxygen and standard care.
The trial protocol includes:
- Up to 128 patients
- Results will be evaluated after every cohort
- Duration is expected to be between 12 and 18 months
The objectives include:
- Optimal dose for OXYCYTE for patients based on Extended Glasgow Outcome Scale
- Optimal dose level that will reduce thrombocytopenia and provide clinical benefit in TBI
- In-depth research to find the correlation between thrombocytopenia and platelets