EANS-Adhoc: Oxygen Biotherapeutics Receives DSMB Approval to Proceed to the Next Cohort in Its Phase II-B Clinical Trial for Traumatic Brain Injury
Geschrieben am 23-09-2010 |
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Research & Development/Biotechnology
23.09.2010
DURHAM, NC, September 23, 2010 - Oxygen Biotherapeutics, Inc. (NASDAQ
& SIX Swiss Exchange: OXBT) reported today that the Data Safety
Monitoring Board overseeing the company´s ongoing Phase II-b trial
has, based on the results of the first cohort of patients, authorized
the company to move forward with the next cohort of the study. This
trial is a randomized, single-dose, placebo-controlled, double-blind,
dose-escalation study to evaluate the safety and tolerability of our
Oxycyte® emulsion in patients with severe non-penetrating traumatic
brain injury. Due to the double-blind design of the study, specific
results will not be reported to the company until the trial closes.
"The absence of any safety concern on the part of the DSMB and their
unanimous recommendation to proceed with the next cohort represents a
significant milestone for our clinical program. We look forward to
moving into doses where signs of efficacy are expected. Recent
updates in the area of traumatic brain injury and feedback from
experts in the field as well as our clinical investigators has
motivated us to consider expanding our existing protocol´s patient
enrollment parameters beyond severe non-penetrating traumatic brain
injury to include mild-to-moderate TBI patients," said Timothy
Bradshaw, Ph.D., Senior Vice President of Clinical Development at
Oxygen Biotherapeutics. "These changes will take time to implement,
but we believe that in the long run it is the right move since more
patients will be eligible to enroll in our trial and potentially
benefit from treatment with Oxycyte."
end of ad-hoc-announcement ==========================================
====================================== What is Oxycyte® PFC Emulsion?
Oxycyte is an emulsion of a proprietary perfluorocarbon (PFC) based
oxygen carrier and is administered to clinical trial patients via
intravenous infusion. The physical properties of PFC enable our
product to gather oxygen from the lungs and transport the oxygen
through the body releasing it along the way. Over a period of days
following administration, Oxycyte is gradually cleared from the body
through the lungs in the course of respiration. Oxycyte requires no
cross matching, so it is immediately available and compatible with
all patients' blood types. It is provided to our clinical researchers
as a sterile emulsion ready for intravenous administration. Because
it contains no biological components, there is no risk of
transmission of blood-borne viruses from human blood products.
Traumatic Brain Injury
According to the Centers of Disease Control, TBI is a contributing
factor to a third (30.5%) of all injury-related deaths in the United
States. About 75% of TBIs that occur each year are concussions or
other forms of mild TBI. The CDC says an estimated 1.7 million
people sustain a TBI annually. Of them:
52,000 die, 275,000 are hospitalized, and 1.365 million, nearly
80%, are treated and released from an emergency department In the
U.S. alone, the direct and indirect costs of TBI are estimated at $60
billion.
Incidence of TBI in all industrialized countries is comparable to the
United States with estimates ranging from 150 to more than 300 per
100,000. There are approximately 66,000 deaths annually attributed
to TBI in Europe.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is developing medical and cosmetic
products that efficiently deliver oxygen to tissues in the body. The
company has developed a proprietary perfluorocarbon (PFC) therapeutic
oxygen carrier and liquid ventilation product called Oxycyte that is
being formulated for both intravenous and topical delivery. This
year, the company launched its DERMACYTE® line of oxygen-rich skin
care products. In addition, the company is focused on
perfluorocarbon-based oxygen carriers for use in traumatic brain
injury, decompression sickness, personal care, and topical wound
healing. More information is available at www.oxybiomed.com or
www.buydermacyte.com.
Caution Regarding Forward-Looking Statements This news release
contains certain forward-looking statements by the company that
involve risks and uncertainties and reflect the company's judgment as
of the date of this release. These statements include the expansion
of research and development of the Oxycyte product line and the
timing of the introduction of those new products. The
forward-looking statements are subject to a number of risks and
uncertainties including matters beyond the companys control that
could lead to delays in new product introductions and customer
acceptance of these new products, and other risks and uncertainties
as described in our filings with the Securities and Exchange
Commission, including in the current report on Form 10-Q filed on
September 9, 2010. The company 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.
end of announcement euro adhoc
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ots Originaltext: Oxygen Biotherapeutics Inc.
Im Internet recherchierbar: http://www.presseportal.de
Further inquiry note:
Ellen Corliss
Vice President, Corporate Communications
& Investor Relations
Oxygen Biotherapeutics, Inc
2530 Meridian Pkwy, 3rd floor
Durham, NC 27713
Direct Telephone: +1 919 855 2112
Direct Fax: +1 919 806 4417
Email: e.corliss@oxybiomed.com
Branche: Biotechnology
ISIN: US69207P2092
WKN: 10728277
Index: SSIRT
Börsen: New York / Nasdaq
SIX Swiss Exchange / Main Standard
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weitere Artikel:
- EANS-Adhoc: Oxygen Biotherapeutics erhält DSMB Bewilligung für die nächste Kohorte der klinischen Versuche der Phase II-b Studie STOP-TBI
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Forschung/Entwicklung/Biotechnologie
23.09.2010
DURHAM, North Carolina, USA Oxygen Biotherapeutics, Inc. (NASDAQ &
SIX Swiss Exchange: OXBT) gibt heute bekannt, dass das Data Safety
Monitoring Board welches den laufenden mehr...
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announcement.
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