ISNES, Belgium, June 30, 2022 (GLOBE NEWSWIRE) -- ERC Belgium S.A. (ERC), announced publication of its most recent efficacy data in the May 2022 edition of Frontiers in Oncology. 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/SITOIGANAP) more than doubles median overall survival to 19.6 months. This is an unprecedented level of effectiveness for a disease for which new therapies have shown no improvement in the past twenty years.
Compared to historical controls, where the majority of patients succumb to rGBM within less than a year and 2-year survival is exceedingly rare, the current study reported 1-year survival of 61% of the Sitoiganap-treated patients, and 2-year survival was 45%. As important was the observation that courses of Sitoiganap treatment were well tolerated with minimal toxicity over current therapy.
Corresponding author, Daniela Bota, MD, PhD, commented, “These results for Sitoiganap in rGBM represent the most promising responses yet seen. We are excited to accelerate the clinical development of Sitoiganap.” Dr. Bota is Vice Dean for Clinical Research UCI School of Medicine and the Team Director, UCI Health Comprehensive Brain Tumor Program.
Apostolos Stathopoulos, M.D., Ph.D., President and CEO of ERC Belgium, commented, “We are thrilled that patients with rGBM finally have access to a therapy that can achieve prolonged survival. Equally exciting is that we observe improvements in functionality and quality of life in many of the patients who responded to the treatment. We are now in a position to move ahead with confidence with the company’s clinical trial plans for the United States, as well as with other approaches to treatment that include right-to-try and compassionate use pathways, expanded access options and more, which will take place in many countries throughout the world.”
About Sitoiganap / Gliovac / ERC 1671/SITOIGANAP
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.
Epitopoietic Research Corporation (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. The company headquarters are based in Belgium, with subsidiaries in the United States, the Netherlands, Canada and Australia, along with an international presence throughout the world and country-specific agreements within Europe and Latin America. ERC has assembled a network of leading neuro-oncologists in many countries, in order to propel its immunotherapies through clinical development and to market. While the company’s vaccine has shown great promise in patients suffering from recurrent glioblastoma, this therapeutic approach may be considered a platform application, as it potentially could be applicable to many other types of difficult-to-treat cancers. As such, it has the potential to bring new hope to patients with otherwise dismal prognosis.