ERC-USA and the University of California, Irvine (UCI), today announced that the FDA has recommended early termination of the ongoing Phase 2 clinical trial titled ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma in a letter dated April 2, 2021. 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, 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.
UC Irvine Principal Investigator POV
The principal investigator of the ERC1671 clinical trial, Dani...
Note: If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).