ARTICLE | Clinical News

CRS-207: Phase IIb hold

October 31, 2016 7:00 AM UTC

Aduro said FDA placed a partial clinical hold on trials evaluating candidates developed through the company’s live-attenuated double-deleted Listeria monocytogenes (LADD) technology. The hold pauses new patient enrollment but allows patients already treated with LADD-based immunotherapy products to continue treatment. Aduro said FDA placed the hold after a blood culture sample from a pancreatic cancer patient in the open-label, North American Phase IIb ECLIPSE trial of CRS-207 plus GVAX Pancreas vaccine tested positive for Listeria several months after treatment. The company said the patient was given antibiotics and that further blood cultures tested negative for Listeria. Aduro is proposing revised study protocols to FDA.

In November 2015, Aduro disclosed that another pancreatic cancer patient treated with CRS-207 and GVAX Pancreas developed listeriosis in a Phase IIa trial. At the time, the company said the infection was likely attributable to a protocol violation and that all of its clinical trials would continue as planned...