ERC Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP
ISNES, Belgium--(BUSINESS WIRE)-- ERC Belgium, a clinical-stage biopharmaceutical company developing immunotherapies for the treatment of cancer, has announced 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).
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.”
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.
About ERC Belgium
ERC-Belgium SA, is a clinical stage emerging Biopharmaceutical Company developing a safe, highly effective approach for the treatment of cancer, particularly cancers of the brain. ERC has built a network of leading neuro-oncologists in several countries in the world, among others in the US and Europe to propel its immunotherapies through clinical development and to market. ERC’s regimen of therapeutic vaccines has shown early promise in patients suffering from recurrent Glioblastoma multiforme (GBM), the deadliest of brain cancers. We are very proud to provide the product for patients that are not eligible for the current clinical trials, under the RIGHT TO TRY law and other new programs established by different medical centers in the United States.
The company’s therapeutic approach is also being applied to a developmental vaccine against COVID-19 and can be potentially applied to many other types of solid cancers. ERC Belgium is based in Isnes, Belgium with subsidiaries in the U.S.A., Netherlands, Canada, Australia and an international presence throughout country-specific agreements within Europe and Latin America. To learn more, please visit http://erc-immunotherapy.com.
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Source: ERC Belgium
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