Aduro Announces Completion of Enrollment in Phase 2 Clinical Trial
Aduro BioTech, Inc.Steven Bodovitz, Ph.D., +415-336-2700
Aduro BioTech, Inc. announces completion of enrollment in the Phase 2 clinical trial of the sequential administration of two cancer vaccines, Aduro’s CRS-207 and GVAX Pancreas Cancer Vaccine, in patients with metastatic pancreatic cancer (ClinicalTrials.gov Identifier: NCT01417000). Enrollment was completed eight months ahead of schedule.
“We believe the rate of enrollment demonstrates significant interest in this vaccine treatment from our clinical investigators and their patients and reflects the high-quality work and dedication of our clinical trial sites,” said Dr. Dirk Brockstedt, Senior Vice President of Research and Development at Aduro.
The vaccine regimen has been administered in an outpatient setting and has been well-tolerated thus far with no serious or unexpected adverse events related to the study vaccines. A formal interim analysis of the safety and efficacy of the randomized, controlled trial is expected in the first quarter of next year.
“Metastatic pancreatic cancer is a devastating disease,” said Stephen Isaacs, Chairman and Chief Executive Officer of Aduro. “We are optimistic that the results of this trial will reveal a promising new therapeutic option that can extend life and increase quality of life.”
Aduro is advancing multiple therapeutic and prophylactic vaccines for cancer and infectious diseases based on its proprietary attenuated vaccine platforms. The company is also advancing a new program towards clinical evaluation that utilizes targeted small molecule immune modulators that have broad application for vaccine design. The company's platform has been validated by 26 publications that illustrate the platform's unique combination of safety and potency, and the platform has received more than $24 million in federal and private grant and contract funding. In addition, the company has multiple patents issued in the U.S., Europe and throughout the world that broadly protect its proprietary and clinical applications. The company’s lead therapeutic, CRS-207, is currently being evaluated in a randomized, controlled Phase 2 trial in patients with metastatic pancreatic cancer, in which enrollment has completed, and a Phase 1B clinical trial in patients with malignant pleural mesothelioma, in which enrollment is ongoing.