FDA-requested Oxycyte tests successful
The manufacturer is pleased with results of investigation into Oxycyte's effects on immunocompetence.
The US Food and Drug Administration (FDA) requested further investigation into the safety of Oxycyte, and manufacturer Oxygen Biotherapeutics Inc says studies have been completed successfully.
Four pre-clinical investigations were launched in order to verify the safety of the artificial oxygen carrier, since concerns were raised about its impact on immunocompetence.
Experiments showed that patients administered the medicine exhibited only minor reductions in influenza antibody production, meaning that the immune response to the infection was not seriously compromised.
Other investigations suggest that a prescription should only have a limited and relatively insignificant impact on the fight against bacteria, although patients' ability to fend of a Listeria was seriously affected.
Vice president of drug development at the manufacturer Dr Timothy Bradshaw said: "Overall we [...] are pleased with the immunocompetency data collected over the last several months."
Further scientific investigation must verify whether the potential side-effects of the drug in patients being treated for oxygen-starved tissues, potentially a consequence of traumatic brain injury, are outweighed by the benefits.
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