On June 26, 2020 ERC Belgium, a clinical-stage biopharmaceutical company developing immunotherapies for the treatment of cancer, reported that it has submitted to the EMA its Marketing Authorization Application (MAA) for conditional approval of its lead product SITOIGANAP (ERC1671) to treat recurrent glioblastoma (GBM) (Press release, ERC Belgium, JUN 26, 2020, View Source [SID1234561485]).
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The MAA contains observations suggesting safety and efficacy of SITOIGANAP demonstrated from the interim data of a randomized double-blind phase II trial. The data show that administration of SITOIGANAP/GM-CSF/Cyclophosphamide combined with bevacizumab results in a clinically meaningful survival benefit with minimal toxicity.
The SITOIGANAP regimen presents unique advantages in comparison to historical controls and it significantly increased overall survival and median survival compared to controls. Moreover, current clinical data supports the safety of this product, with no severe adverse events observed; related side effects were grade 1 and 2 headache and local skin reactions.
Approximately 10% of the patients that received SITOIGANAP experienced total recovery and survived longer than 3 years when treated following GBM recurrence and after receiving standard of care. In contrast, no spontaneous remissions were observed in the control group, and all patients showed tumor progression.
Apostolos Stathopoulos, MD, PhD, President and CEO of ERC Worldwide commented, "We are excited to see such strong results from SITOIGANAP, especially the high number of patients going into remission. The beneficial advantage that we are bringing to patients suffering from this orphan disease like GBM is groundbreaking, especially being able to help those patients who have advanced to a stage without alternative therapeutic options."
About SITOIGANAP
SITOIGANAP is an advanced immunotherapy based on freshly extracted tumor cells and lysates that stimulates the patient’s immune system to recognize and reject cancer cells. The immunotherapy contains a combination of autologous tumor cells, and allogeneic tumor cells, generated from the glioma tumor tissues of three different donor cancer patients, and the lysates of all of these cells. Upon injection, this mixture stimulates the patient’s immune system to mount an immune response against the tumor cells, which may lead to their destruction.
SITOIGANAP is for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed. The response to SITOIGANAP is the same whether the MGMT promoter is methylated or unmethylated.
SITOIGANAP is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma multiforme and gliosarcoma.