Epitopoietic Research Corporation

ERC Granted FDA Fast Track Designation for Sitoiganap in Patients with Recurrent Glioblastoma

Retrieved on: 
Tuesday, July 26, 2022
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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) ERCs cell-based immunotherapy for the treatment of glioblastoma, the most aggressive form of brain cancer.

Key Points: 
  • 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) ERCs cell-based immunotherapy for the treatment of glioblastoma, the most aggressive form of brain cancer.
  • The FDA stated, That Sitoiganap, combined with GM-CSF and cyclophosphamide and bevacizumab, for the treatment of recurrent glioblastoma to improve overall survival meets the criteria for Fast Track designation.
  • Apostolos Stathopoulos, M.D., Ph.D., ERC Belgium President and CEO commented, Receiving Fast Track designation from the FDA reinforces ERCs belief that our cell-based immunotherapy for the treatment of serious cancers represent a major breakthrough.
  • Sitoiganap is for patients suffering from a grade IV glioma (glioblastoma and gliosarcoma) when all other traditional treatments have failed.

ERC Announces Publication of Positive Efficacy Data with Sitoiganap in Patients with Recurrent Glioblastoma

Retrieved on: 
Thursday, June 30, 2022
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The authors reported striking efficacy and safety of a therapeutic vaccine SITOIGANAP administered to 21 patients with recurrent glioblastoma (rGBM).

Key Points: 
  • The authors reported striking efficacy and safety of a therapeutic vaccine SITOIGANAP administered to 21 patients with recurrent glioblastoma (rGBM).
  • Glioblastoma has a dismal prognosis with half of rGBM patients dying within 8 months of recurrence of the disease.
  • Data presented by the authors show that treatment with Sitoiganap (also called Gliovac or ERC1671) more than doubles median overall survival to 19.6 months.
  • Sitoiganap is for patients suffering from a grade IV glioma (glioblastoma and gliosarcoma) when all other traditional treatments have failed.