ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 (Gliovac or Sitoiganap) and Application for Registration Trial for Treatment of Glioblastoma
IRVINE, Calif., April 07, 2021 (GLOBE NEWSWIRE) — ERC-USA and the University of California, Irvine (UCI), today announce that the FDA has recommended early termination of the onging Phase 2 clinical trial titled ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma in a letter dated April 2, 2021 (https://clinicaltrials.gov/ct2/show/NCT01903330?term=Bota&draw=2&rank=3). The FDA further recommended that the parties pursue a randomized confirmatory Phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA).
This advice from the FDA is a major advance for the clinical development of ERC1671, a cell-based immunotherapy currently under development for the treatment of recurrent glioblastoma for which there are no effective available treatments. The company previously presented preliminary survival data, which demonstrated that active treatment combined with bevacizumab maintained median overall survival of 11 months, compared to historical controls demonstrating median overall survival of 5.3 months. Further, these data demonstrated an activated immune response (CD3/CD4 count) that correlated with overall survival.
The principal investigator of the ERC1671 clinical trial, Daniela A. Bota, M.D., Ph.D., Vice Dean for Clinical Research, University of California, Irvine School of Medicine, and Medical Director, UCI Health Comprehensive Brain Tumor Program, said, “We are highly reassured that the FDA shares our view that ERC1671 should enter a registration trial and move toward an NDA as soon as possible.”
Apostolos Stathopoulos, M.D., Ph.D., President and CEO of ERC Belgium, parent company to ERC-USA, added, “We are thrilled that the FDA now recognizes the potential of ERC1671 to treat this intractable disease and major unmet medical need. We believe ERC1671 provides significant hope to patients with recurrent glioblastoma and we are grateful to the FDA’s encouragement to aggressively enter into a registration trial.”
About ERC 1671/ Sitoiganap / Gliovac
ERC1671 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 and gliosarcoma) when all other traditional treatments have failed. The response to SITOIGANAP is the same whether the MGMT promoter is methylated or unmethylated. ERC1671 is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma and gliosarcoma.
About ERC
ERC-USA is a subsidiary of Epitopoietic Research Corporation (ERC-Belgium SA), 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 (GBM), the deadliest of brain cancers.
The company’s therapeutic approach can be potentially applied to many other types of solid cancers. Based in Belgium with subsidiaries in the U.S.A., the Netherlands, Canada and Australia as well as an international presence throughout the world with country specific agreements within Europe, and Latin America. To learn more, please visit http://erc-immunotherapy.com.
About UCI
University of California, Irvine (UCI) was founded in 1965 with a mission to catalyze the community and enhance lives through rigorous academics, cutting-edge research, and dedicated public service. The UCI Health Comprehensive Brain Tumor Program offers access to expertise, leading-edge treatments and promising clinical trials, providing patients with the best outcomes possible.
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