Navigation Links
Oxygen Biotherapeutics, Inc. Receives Phase II Trial Approval in Israel

DURHAM, N.C., Sept. 23 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received approval from Israel's Ministry of Health to begin a Phase II-b, dose escalation, clinical trial in that country for use of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

"This approval from the Israeli Ministry of Health means that we can begin enrolling patients in a second country with a first class health care system," said Chris Stern, company chairman and CEO. "We hope this trial can provide data to show that Oxycyte is of invaluable importance in improving the outcome of patients, both civilian and military, with severe TBI. It is our goal to finally prove that there is a safe and effective treatment for this devastating injury."

The clinical trial with four centers in Israel is part of a larger study that also includes seven trial centers in Switzerland. The company has named the 128 patient study "Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury" or "STOP TBI."

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 would 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 under development a perfluorocarbon (PFC) therapeutic oxygen carrier and liquid ventilation product (Oxycyte(R)) 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. More information is available at

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by Oxygen Biotherapeutics, Inc. that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include those referring to the start of a Phase II for Oxycyte in TBI. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that a sufficient number of patients will be enrolled in the trial nor any assurance of the outcomes. Additional information concerning these and other risk factors affecting Oxygen Biotherapeutics, Inc.'s business can be found in the company's public periodic filings with the Securities and Exchange Commission, which are available via Oxygen Biotherapeutics, Inc. disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Oxygen Biotherapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Oxygen Biotherapeutics, Inc. Submits Milestone Achievement Notice to Vatea Fund
2. New NIH-Funded Study Shows Masimo Rainbow SET(R) May Help Clinicians Assess Oxygenation in Children With Sickle Cell Disease
3. Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.
4. Battelle Scientists Named on Patent for Making Oxygen From Light and Water
5. Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers
6. Oxygen Relieves IBS and Constipation Symptoms in New Clinical Studies
7. Alliance Pharmaceutical Corp. Updates Oxygent(TM) Clinical Development Plan
8. Childrens Hospital Receives Six-Year Federal Contract to Study Antibiotic Use in Children With Urinary Tract Infections
9. ISTA Pharmaceuticals Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
10. Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
11. Cytopias CYT387 Receives FDA Clearance to Start US Clinical Trials
Post Your Comments:
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 /PRNewswire/ ... Diabetes Tomorrow,s Leaders Scholarship is any indication, the future ... today online at by the Diabetes ... stand in the way of academic and community service ... scholarship program since 2012, and continues to advocate for ...
(Date:6/23/2016)... June 23, 2016 The vast majority of ... dialysis facility.  Treatments are usually 3 times a week, ... visit, including travel time, equipment preparation and wait time. ... especially grueling for patients who are elderly and frail.  ... nursing and rehabilitation centers for some duration of time. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... Beach, CA (PRWEB) , ... June 25, 2016 , ... ... UCLA with Magna Cum Laude and his M.D from the David Geffen School of ... Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at the ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
Breaking Medicine News(10 mins):