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news.Synthetic Blood International is to initiate phase II trials with its proprietary perfluorocarbon blood substitute and therapeutic oxygen carrier, Oxycyte, in patients with traumatic brain injury and with sickle cell anemia.
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The company also said that in an effort to advance Oxycyte through the clinical development process and secure phase II data rapidly, it has temporarily suspended patient enrollment in its phase II clinical trial in patients with hip revision surgery to allocate resources to the smaller, faster phase II studies.
“Our objective to move Oxycyte toward market approval quickly and cost effectively is best served by actively moving forward with these smaller trials,” said Robert Nicora, Synthetic Blood President and CEO. “While five highly reputable clinical sites are participating in our hip revision surgery trial, and patient recruitment has been proceeding, enrollment has been slower than we had anticipated.”
Synthetic Blood believes that recruitment in the eight-patient traumatic brain injury trial and the 20-patient sickle cell trial will be rapid, as both indications represent unmet medical needs with no available alternative therapies. Both trials are to be conducted at Virginia Commonwealth University Hospital.