The FDA has recommended the manufacturer of a cell-based immunotherapy terminate a phase 2 clinical trial assessing its effectiveness in recurrent or progressive glioblastoma early and pursue a phase 3 trial which may lead to an approval.
The Food and Drug Administration (FDA) recently recommended that ERC-USA and the University of California, Irvine terminate an ongoing phase 2 clinical trial investigating ERC1671 in the treatment of patients with recurrent or progressive glioblastoma, according to a news release from ERC-USA.
Moreover, the FDA also recommended that the two seek out a randomized phase 3 registration trial to confirm preliminary results and support a licensing application that could eventually make the cell-based immunotherapy available to the public if approved by the agency.
“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,” said lead study author Dr. Daniela A. Bota, vice dean for clinical research at the Irvine School of Medicine and medical director of the UCI Health Comprehensive Brain Tumor Program, in the release.
Previous preliminary study results have demonstrated that combining ERC1671 with Avastin (bevacizumab) induced a median overall survival of 11 months in patients, which was superior to a median overall survival of 5.3 months with historical controls. The data also showed an activated immune response to the combination therapy that correlated with the overall survival data.
ERC1671 is being developed to treat patients with recurrent glioblastoma, a disease for which, according to the manufacturer, there are no effective treatment options.
“We are thrilled that the FDA now recognizes the potential of ERC1671 to treat this intractable disease and major unmet medical need,” said Dr. Apostolos Stathopoulos, president and CEO of ERC Belgium (a parent company to ERC-USA), said in the 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.”
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