ERC-USA announced that the FDA recommended the early termination of a phase 2 clinical trial of ERC1671 to treat patients with recurrent or progressive glioblastoma and pursue a randomized confirmatory phase 3 trial.
The FDA recently recommended the early termination of a phase 2 clinical trial investigating ERC1671 to treat patients with recurrent or progressive glioblastoma, according to an ERC-USA press release.
The FDA recommended that the parties for the phase 2 ERC1671/GM-CSF/Cyclophosphamide clinical trial (NCT01903330) should pursue a randomized phase 3 trial to confirm the results and support a biologics license application (BLA) for ERC1671.
“We are highly reassured that the FDA shares our view that ERC1671 should enter a registration trial and move toward an [new drug application] as soon as possible,” principal investigator Daniela A. Bota, MD, PhD, vice dean for clinical research at the Irvine School of Medicine and medical director of the UCI Health Comprehensive Brain Tumor Program, said in a press release.
Previous preliminary survival data regarding the combination treatment of ERC1671 plus bevacizumab found a median overall survival (OS) rate of 11 months, which compared favorably to historical controls that produced a median OS of 5.3 months. The corresponding data also produced an activated immune response that correlated with the OS data observed.
In the phase 2 trial, 84 patients were randomly assigned to receive either ERC 1671 in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) and cyclophosphamide or placebo, plus bevacizumab (Avastin).
The cell-based immunotherapy, ERC1671, is being developed to treat patients with recurrent glioblastoma, a disease for which there are no effective treatment options currently available.
The therapy is based on freshly extracted tumor cells and lysates that work to stimulate a patient’s immune system to reject cancerous cells. When injected, the immunotherapy tells a patient’s immune system to target and destroy cancer cells.
“We are thrilled that the FDA now recognizes the potential of ERC1671 to treat this intractable disease and major unmet medical need,” Apostolos Stathopoulos, MD, PhD, president and CEO of ERC Belgium, said in a press release. “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.”
ERC-USA is a clinical stage Biopharmaceutical Company that works to develop effective cancer treatment options, with a specific focus on brain cancers. The company is based in Belgium, with subsidiaries located in the United States, the Netherlands, Canada and Australia.
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. News release. ERC-USA. Published April 7, 2021. Accessed April 7, 2021. https://www.globenewswire.com/news-release/2021/04/07/2205843/0/en/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-Gliobl.html