Pharmaceutical Company Completes Enrollment for Phase 1B Trial for Mesothelioma
Insulators International Staff — Wed, Aug 26, 2015 @ 14:08 PM
Recently, Aduro Biotech issued a press release announcing the completion of enrollment in the Phase 1b clinical trial of its novel immunotherapy, CRS-207. I took the opportunity to call and congratulate Steve Isaacs, the chairman, president, and CEO of Aduro Biotech, on his initial trial results and his plan to move this drug along quickly and offer it globally in the Phase 3 setting.
It is exciting to see plans to jump from a Phase 1b directly to Phase 3 based on what was agreed to be compelling data by the FDA.
Patients treated on the Phase 1b study received 2 doses of CRS-207, a vaccine that utilizes the listeria virus and mesothelin as a target to gain entry into the cell. Patients then went on to receive standard of care pemetrexed/cisplatin every three weeks for 6 courses. If patients were stable or responded to the aforementioned therapy, they were then placed on a maintenance regimen of vaccinations every 8 weeks until progression.
Interim data was presented at a large scientific conference and demonstrated that in the 32 evaluable patients treated on this clinical trial, disease control was observed in 94%, which included a 60% partial response, and 34% experiencing stable disease.
The study will remain open to chemotherapy naive patients (patients who have never received chemotherapy for their mesothelioma) while the plans for the Phase 3 trial continue.