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) ERC’s cell-based immunotherapy for the treatment of glioblastoma, the most aggressive form of brain cancer. Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical needs. The purpose is to get important new drugs to the patient earlier. 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.” Fast Track addresses a broad range of serious conditions.

Apostolos Stathopoulos, M.D., Ph.D., ERC Belgium President and CEO commented, “Receiving Fast Track designation from the FDA reinforces ERC’s belief that our cell-based immunotherapy for the treatment of serious cancers represent a major breakthrough. We are pleased that the FDA’s decision reinforces the observation of improved median overall survival (mOS) in these patients as well as continued improvements in functionality and quality of life in the patients who responded to Sitoiganap^® treatment. Furthermore, Fast Track makes Sitoiganap^® eligible for the FDA’s Accelerated Approval process and Priority Review.”

About Sitoiganap/Gliovac/ERC 1671

Sitoiganap is an advanced immunotherapy derived from brain tumor tissue that is surgically removed from patients with rGBM. Such tumor tissue is then processed to obtain inactivated intact cells and disrupted lysed cells from different patients. For treatment, each patient receives repeated intradermal injections of this material (autologous component), along with the same material derived from three different other cancer patients (allogeneic component). This complex mixture of own and foreign material serves as a strong stimulant of the patient’s immune system and mounts a reactive immune response against the residual tumor cells, leading to their destruction.

Sitoiganap is for patients suffering from a grade IV glioma (glioblastoma and gliosarcoma) when all other traditional treatments have failed. The indication for Sitoiganap is independent of the tumor’s genomic profile; because of the vaccine’s complex composition, the immune response it triggers is targeted at a great variety of tumor epitopes and minimizes the development of treatment resistance. In the United States, the vaccine is currently undergoing a randomized, placebo-controlled Phase 2 clinical trial as part of combination treatment for recurrent glioblastoma and gliosarcoma.