Register for free to listen to this article
Listen with Speechify
0:00
2:00
MORRISVILLE, N.C.—OxygenBiotherapeutics Inc. recently announced that it has tapped PharmaceuticalProduct Development LLC (PPD), a global contract research organization, toresume and complete OBI's STOP-TBI (Safety and Tolerability of Oxycyte inPatients with Severe non-Penetrating Traumatic Brain Injury) Phase II-bclinical trial.
 
 
"The development of Oxycyte as a potential breakthroughtherapy for severe traumatic brain injury remains the top priority of thiscompany, and for the past 12 months, we have remained committed to resumingenrollment in our clinical trials. Engaging a qualified CRO is a critical stepin getting trial sites back up and running and open for enrollment byyear-end," said Michael Jebsen, president and chief financial officer of OBI.
 
 
OBI completed the first cohort of a planned three-cohortdose-escalation study. Based on unblinded review of safety data from the 11enrolled patients, the Data Safety Monitoring Board (DSMB) unanimously approvedinitiating Cohort 2. Cohorts 2 and 3 will enroll 18 subjects each with the DSMBreviewing safety data at the end of each cohort. An additional 50 patients withsevere TBI will be treated at the highest dose approved by the DSMB. Thecompany expects the trial to be completed in late 2015.
 
The primary objective of the trial is to evaluate the safetyand tolerability of a single administration of Oxycyte in patients with severenon-penetrating traumatic brain injury. The secondary objective is to assessthe potential of Oxycyte in ameliorating the severity of TBI and represents anopportunity for the collection of placebo-controlled efficacy data,specifically, clinical and functional improvement. Functional status will bemeasured by the Glasgow Outcome Scale (GOS-E), a validated tool that helps toassess progress in patient recovery from their injury.
 
"We are pleased to be working with PPD as our CRO to overseethe completion of this critical trial," said Dr. Timothy Bradshaw, executivevice president of drug development at OBI. "We selected PPD for their globalreach and expertise conducting trials in which critically injured subjects areidentified and managed in an emergency or trauma setting. They have presented agreat operational plan for ensuring the successful completion of the study. Inaddition, PPD has medical staff with therapeutic expertise in neurotrauma. Ourfocus now is getting sites ready to enroll patients."

Related Topics

Published In

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

A doctor wearing blue gloves and a white lab coat with a stethoscope around their neck holds a rendering of a digestive system on a glass pane with a swirled blue background.

Connecting the gut and liver to enhance drug development

Explore how a dual-organ microphysiological system connects human gut and liver tissue to bridge gaps in predicting how drugs behave in the body.
A syringe draws liquid from a glass vial, with several glass ampoules reflected on a glossy surface in the background

Turning up the heat: thermal analysis for biotherapeutics

Explore essential thermal stability techniques to ensure the safety, quality, and efficacy of biologic drugs.
A 3D-rendered image of a pink and white twisted RNA strand floating against a green, blurred cellular background.

Cutting the time and cost out of plasmid generation

Discover a hassle-free path to obtaining long, complex plasmid DNA.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue