ERC-USA and the University of California, Irvine (UCI), today announce that the FDA has recommended early termination of the onging Phase 2 clinical trial titled ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma in a letter dated April 2, 2021 (https://clinicaltrials.gov/ct2/show/NCT01903330?term=Bota&draw=2&rank=3
). The FDA further recommended that the parties pursue a randomized confirmatory Phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA).
This advice from the FDA is a major advance for the clinical development of ERC1671/SITOIGANAP, a cell-based immunotherapy currently under development for the treatment of recurrent glioblastoma for which there are no effective available treatments. The company previously presented preliminary survival data, which demonstrated that active treatment combined with bevacizumab maintained median overall survival of 11 months, compared to historical controls demonstrating median overall survival of 5.3 months. Further, these data demonstrated an activated immune response (CD3/CD4 count) that correlated with overall survival.
The principal investigator of the ERC1671 clinical trial, Daniela A. Bota, M.D., Ph.D., Vice Dean for Clinical Research, University of California, Irvine School of Medicine, and Medical Director, UCI Health Comprehensive Brain Tumor Program, said, “We are highly reassured that the FDA shares our view that ERC1671 should enter a registration trial and move toward an NDA as soon as possible.”
Apostolos Stathopoulos, M.D., Ph.D., President and CEO of ERC Belgium, parent company to ERC-USA, added, “We are thrilled that the FDA now recognizes the potential of ERC1671 to treat this intractable disease and major unmet medical need. We believe ERC1671 provides significant hope to patients with recurrent glioblastoma and we are grateful to the FDA’s encouragement to aggressively enter into a registration trial.”