This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Oxygen Biotherapeutics Engages PPD To Execute Remainder Of Phase IIb Clinical Trial To Evaluate The Safety And Tolerability Of Oxycyte® In Severe Traumatic Brain Injury

Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT), announced today that it is partnering with Pharmaceutical Product Development, LLC (PPD), a global contract research organization, to resume and complete OBI’s STOP-TBI ( S afety and T olerability of O xycyte in P atients with Severe non-Penetrating T raumatic B rain I njury) Phase II-b clinical trial.

“The development of Oxycyte® as a potential breakthrough therapy for severe traumatic brain injury remains the top priority of this company, and for the past 12 months we have remained committed to resuming enrollment in our clinical trials. Engaging a qualified CRO is a critical step in getting trial sites back up and running and open for enrollment by year-end,” said Michael Jebsen, President and Chief Financial Officer of OBI.

OBI completed the first cohort of a planned three cohort dose escalation study. Based on unblinded review of safety data from the 11 enrolled patients, the Data Safety Monitoring Board (DSMB) unanimously approved initiating Cohort 2. Cohorts 2 and 3 will enroll 18 subjects each with the DSMB reviewing safety data at the end of each cohort. An additional 50 patients with severe TBI will be treated at the highest dose approved by the DSMB. The company expects the trial to be completed in late 2015.

The primary objective of the trial is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury. The secondary objective is to assess the potential of Oxycyte in ameliorating the severity of TBI and represents an opportunity for the collection of placebo-controlled efficacy data, specifically, clinical and functional improvement. Functional status will be measured by the Glasgow Outcome Scale (GOS-E), a validated tool that helps to assess progress in patient recovery from their injury.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.79 0.10%
FB $101.98 0.07%
GOOG $682.32 -0.12%
TSLA $150.99 0.35%
YHOO $27.04 1.00%


Chart of I:DJI
DOW 15,973.84 +313.66 2.00%
S&P 500 1,864.78 +35.70 1.95%
NASDAQ 4,337.5120 +70.6750 1.66%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs