Oxygen Biotherapeutics, Inc. Enrolls First Patient in Traumatic Brain Injury Clinical Trial in Switzerland
04 Dezember 2009 - 5:08PM
PR Newswire (US)
DURHAM, N.C., Dec. 4 /PRNewswire-FirstCall/ -- Oxygen
Biotherapeutics, Inc. (OTC:OXBT) (BULLETIN BOARD: OXBT) today
announced that the first patient has been enrolled in the company's
Phase II-b, dose escalation, clinical trial in Switzerland for use
of Oxycyte(TM) emulsion in traumatic brain injury (TBI). Oxycyte is
the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
"This trial is of invaluable importance in improving the outcome of
patients with severe TBI. We hope to finally prove that there is a
safe and effective treatment for this devastating injury," said
Chris Stern, company chairman and CEO. "I know that our
shareholders have been wondering why it has taken so long to dose
the first patient. It has taken longer than expected due to
important training and logistical considerations at the trial
sites. Those are being resolved on a site-by-site basis and
enrollment should now start progressing. I'll go into more detail
on that in my blog over the weekend. But I have to emphasize that
our main criterion in the trial is safety. We therefore
intentionally did not rush enrollment in the early stage. Our early
competitors showed us how dangerous it is to rush a trial. We will
not do that." Out of respect for the privacy of the patients and
their families, the company will not be disclosing any identifying
information about patients in the study or the type of accident
that caused the TBI. The company has named the 128 patient study
"Safety and Tolerability of Oxycyte in Patients with Traumatic
Brain Injury" or "STOP TBI". 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, which is being supervised
by a contract research organization, PFC Pharma Focus AG. The
principal investigator is Dr. Michael Reinert of the Department of
Neurosurgery at the University Hospital of Berne. The dose
escalation studies will focus on finding the lowest dose of Oxycyte
that provides clinical benefit in traumatic brain injury while
minimizing adverse effects. Dose levels of Oxycyte will start at
1.0 ml/kg body weight and escalate in steps to 2.0 ml/kg, and 3.0
ml/kg for subsequent patient cohorts. Escalation of dose will only
occur after a favorable review of safety data by an independent
Data Safety Monitoring Board. About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing
innovative pharmaceuticals and medical devices in the field of
oxygen therapeutics and Defense Medicine(TM). The company has
developed a perfluorocarbon (PFC) therapeutic oxygen carrier and
liquid ventilation product (Oxycyte(TM)) and has out-licensed an
implantable glucose sensor. These products are based upon core
technologies that include biomedical applications for PFCs as well
as medical and industrial applications for biosensors. Each of the
product candidates is designed with advantages over currently
marketed products in major markets including traumatic brain
injury, sickle cell crisis, trauma, wound care, decompression
sickness, acute respiratory distress syndrome, stroke, myocardial
infarction, surgery, diabetes wounds and ulcers, and cosmetic
applications which are being marketed under the Dermacyte name.
More information is available at http://www.oxybiomed.com/.
DATASOURCE: Oxygen Biotherapeutics, Inc. CONTACT: Abe Wischnia of
Abe Wischnia & Associates, +1-619-795-2345; or European Media,
Markus Stadler of Prime Communications AG, +41 44 287 36 30, both
for Oxygen Biotherapeutics, Inc. Web Site:
http://www.oxybiomed.com/
Copyright