ISNES, Belgium, July 26, 2022 (GLOBE NEWSWIRE) ERC Belgium S.A. (ERC), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sitoiganap (Gliovac or ERC1671)
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ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 .
ERC-USAApril 7, 2021 GMT
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).
ERC-USA
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
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
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).