Oxygen Biotherapeutics, Inc. announced today enrollment of its first patient in Phase II-b clinical trials for a new drug. The trial, which is to take place in Switzerland, will utilize OXBT’s perfluorocarbon (PFC) therapeutic oxygen carrier, Oxycyte(TM), in emulsion form for the treatment of traumatic brain injury (TBI).
Chairman and CEO of OXBT Chris Stern noted the “invaluable importance” of the drug for enhancing TBI sufferer’s recovery, touting Oxycyte as long awaited proof of a “safe and effective treatment for this devastating injury.”
Stern restored shareholder morale lost over the extended period preceding initial patient dosing, explaining that the on-site “logistical” concerns and personnel readiness operations required to ensure success were necessary because, as he put it “our main criterion in the trial is safety”.
Stern reminded everyone of the failures of OXBT’s early competitors in rushing to market, and confirmed his commitment to avoid such pitfalls, saying that is why the Company “did not rush enrollment in the early stage”.
Stern assured investors that such logistical considerations were being resolved in a “site-by-site” fashion and that “enrollment should now start progressing.”
Citing his blog as an access point for people who want to dig deeper, he encouraged people to check in over the weekend for status updates. Due to the nature of TBI and out of respect to the privacy of the patient, OXBT will maintain a policy of non-disclosure on identifying information of patients involved in this study.
Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury (STOP TBI) is the formal name of the study for which OXBT has thus far enrolled 128 patients. Due to the nature of TBI, participants in the study will be emergency cases, complicating when and how patients come into the study, a process to be overseen by PFC Pharma Focus AG (PFC).
The PFC investigation will be organized by University Hospital of Berne neurosurgeon Dr. Michael Reinert. This is a dose escalation study and will, as the title suggests, attempt to determine the minimum threshold for Oxycyte dosage which provides clinical benefit for TBI patients.
With dosage escalation regulated by independent safety review, the dosage will start at 1.0 ml/kg (milligrams per kilogram) body weight and rise incrementally by the same amount for subsequent groups of patients.