ERC-USA Initiates Therapy Under Right to Try Law With First Patient In California Using Investigational Compound ERC1671 for Treatment of Glioblastoma
IRVINE, Calif., Jan. 08, 2019 (GLOBE NEWSWIRE) — ERC-USA and the University of California, Irvine have initiated treatment with the company’s investigational compound ERC1671, also known in Europe as Gliovac, which is in Phase 2 clinical trials in the United States, in a patient with aggressive brain cancer who did not qualify for the ongoing trial. This patient will be treated under the Right to Try Law of 2017, which allows patients to undergo treatment with an experimental compound who may not qualify to participate in a registered clinical trial. The law dictates that the compound must have successfully completed basic safety testing and be under the U.S. Food and Drug Administration’s ongoing approval process.
“We are gratified to have the opportunity to offer options for this aggressive cancer, as current treatment modalities have proven unsuccessful,” said Daniela Bota, M.D., Ph.D., medical director, UCI Health Comprehensive Brain Tumor Program and associate professor of neurology, University of California, Irvine School of Medicine. “The Right to Try laws may be the only alternative for many patients who may not qualify for clinical trials based on a variety of factors, including progression of disease, comorbidities, existing medications, physical limitations and others.”
ERC1671, also known as Gliovac in Europe, is an investigational cell-based vaccine currently in is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma multiforme and gliosarcoma. Interim data have demonstrated it as a promising treatment for those who have exhausted other therapies.
The patient was diagnosed with recurrent glioblastoma (GBM), the most aggressive form of brain cancer, but did not qualify for enrollment in the ongoing trial of experimental therapeutic vaccine ERC1671. As a result, the patient requested under the Right to Try laws enacted in California in 2017 to receive treatment with the vaccine. Treatment with ERC1671 was initiated in late November 2018.
“We appreciated the opportunity to provide an option for a patient with such advanced disease under California’s Right to Try act, which we believe is an important step forward in ensuring that all patients who may want to use this option would have access to medications that may prolong or improve their lives,” commented Apostolos Stathopoulos, M.D., Ph.D., president and CEO of ERC Belgium, parent company to ERC-USA.
The ERC1671 (Gliovac™) vaccine 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 vaccine 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.
Gliovac/ERC1671 is for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed. Further studies will target patients with newly diagnosed glioma with predictive marker indicating, unresponsiveness to Temozolomide chemotherapy (MGMT gene promoter unmethylation).
ERC1671 is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma multiforme and gliosarcoma.
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 multiforme (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., Canada, Italy, 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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