Current Clinical Trials
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 (TBI). 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 was enrolled in December 2009. Since study participants will all be emergency cases, it is not possible to predict the precise timing of the flow of patients into the study.

The principal investigator is Dr. Michael Reinert of the Department of Neurosurgery at the University Hospital of Berne. The Insel Hospital in Berne will be the first of the planned seven trial centers in Switzerland and four in Israel to begin enrolling patients. The other trial centers planned for the Swiss study are in Zurich, Aarau, St. Gallen, Basel, Geneva and Lausanne.

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

The company is not currently enrolling patients in any other trials.

The company expects to initiate clinical trials in 2010 using OXYCYTE in the treatment of skin wounds. When details of those trials have been finalized, they will be announced via a company news release.

For information on other clinical trials that are currently enrolling patients, please visit the following site: http://www.clinicaltrials.gov/