ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 (Gliovac or Sitoiganap) and Application for Registration Trial for Treatment of Glioblastoma

Published Apr 07 2021 at 12:12 PM GMT
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  • IRVINE, Calif., April 07, 2021 (GLOBE NEWSWIRE) -- 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, 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 53 months.
  • Further, these data demonstrated an activated immune response (CD3/CD4 count) that correlated with overall survival.




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  • Published Apr 7, 2021 12:12 PM GMT