Oxycyte

Oxycyte is an experimental third-generation perfluorocarbon (PFC) therapeutic oxygen carrier invented by Leland Clark and developed by Oxygen Biotherapeutics, Inc. (OBI; formerly Synthetic Blood International). It is designed to enhance oxygen delivery to damaged tissues.

Product

When used as an intravenous emulsion, Oxycyte can carry as much as five times more oxygen than hemoglobin, making it an effective means of transporting oxygen to tissues and carrying carbon dioxide to the lungs for disposal.[1] Like all PFC-based products, Oxycyte is not a complete blood substitute.

Because Oxycyte is a PFC, and not based on hemoglobin, it does not have the safety issues associated with hemoglobin-based products; there have been no adverse events in company clinical trials that were related to Oxycyte. OBI believes that Oxycyte has a very favorable risk-benefit profile for its potential indications.

OBI has received approval from Swissmedic and the Israeli Ministry of Health to conduct a Phase II, dose escalation, clinical trial in Switzerland and Israel using Oxycyte as an emergency treatment in traumatic brain injury.

The company promotes Oxycyte as having potential for use in multiple indications, including traumatic brain injury, sickle cell crisis, trauma, wound care, decompression sickness, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, diabetic wounds and ulcers and cosmetic applications.

Chemical properties

The active chemical substance in Oxycyte is Perfluoro(tert-butylcyclohexane), a saturated alicyctic PFC (molecular formula C10F20).[2][3]

Treatment of traumatic brain injury

A Phase II-a clinical safety trial with Oxycyte in Traumatic Brain Injury has been completed successfully.[4][5] The company has received approval from Swissmedic and the Israeli Ministry of Health to begin a Phase II, dose escalation, clinical trial in Switzerland and Israel for use of Oxycyte as an emergency treatment for traumatic brain injury (TBI).[6] 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.[7]

Topical and wound care applications

OBI has incorporated Oxycyte into a gel, Dermacyte, for use in topical applications for the over-the-counter cosmetics market. It delivers concentrated oxygen to the skin.[8] It is scheduled for retail sale in 2011[9]

Oxycyte is also the basis of a product to accelerate the healing of wounds by supplying oxygen to injured tissue from the outside in.[10]

The company has conducted safety studies and plans an FDA filing for clinical trials related to this indication in late 2009.

References

  1. ↑ Oxygen Biotherapeutics, Inc. Corporate website.
  2. ↑ Winslow, Robert M. (2006). Blood Substitutes. Academic Press. p. 303. ISBN 978-0127597607.
  3. ↑ US application 12/460,409 M. Ross Bullock et al, filing date July 17, 2009
  4. ↑ Fred Tasker (March 18, 2008). "Miami Herald: Artificial blood goes from science fiction to science fact". Miami Herald (at NoBlood.org). Archived from the original on 2008-03-19.
  5. ↑ Nicole Davis (2006-11-01) Popular Science: "Better than Blood" Popular Science Magazine.
  6. ↑ Oxygen Biotherapeutics, Inc. Adds Oxycyte TBI Clinical Trial Sites In Israel Medical News Today. (from OBI press release) 2009-03-27. Last accessed 2010-03-22.
  7. ↑ "ClinicalTrials.gov". Retrieved 27 October 2014.
  8. ↑ Dermacyte information OBI website.
  9. ↑ SEC Filing Form 10-Q for Oxygen Biotherapeutics, Inc. Quarterly Report March 19, 2010. Last accessed 2010-03-22.
  10. ↑ Oxygen Biotherapeutics develops gel version of oxycyte for treating surface wounds Red Orbit (from OBI press release via Business Wire) 2008-08-12.

External links

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