Duke University leads the way among schools with on-campus CROs, and now Oxygen Biotherapeutics ($OXBT) has entrusted the institution with handling late-stage studies of its promising heart drug.
Oxygen is developing levosimendan to help heart surgery patients steer clear of low cardiac output syndrome (LCOS), a disorder that leads to 10- to 15-fold increase in post-surgery mortality, the company said. The FDA has granted its fast-track designation to the drug, and, with the Duke Clinical Research Institute (DCRI) on board to helm Phase III trials, Oxygen is confident it can win approval based on one successful study.
"We are extremely pleased to have an organization with the skill and expertise in conducting clinical trials that DCRI possesses as our partner," Oxygen CEO John Kelley said in a statement. "They have been responsible for managing a number of major cardiac surgery trials in the last decade, so their knowledge of this area of medicine is invaluable to us."
The partners plan to study levosimendan on 760 patients undergoing coronary artery bypass, testing whether the drug can slash rates of LCOS once enrollment kicks off next year.
For Duke, the latest deal is its third biotech tie-up of the year, coming on the heels of an August agreement to handle early-stage Parkinson's work for the International Stem Cell Corporation ($ISCO) and a March handshake with Benitec Biopharma to run Phase I/II trials for an RNAi hepatitis C drug.
The school's CRO has more than 150 studies under its belt, and Duke bills DCRI as the only university-based contractor that can provide all the services of a large CRO backed up with the academic credibility of a top-tier research institute.
- read the announcement