A study that will deliver CRISPR gene editing technology directly into cancer cells in patients' bodies is preparing to seek regulatory approval from the FDA, STAT reports.
The study, proposed by Newark, Del.-based Christiana Care Health System's gene editing institute, would be the first of its kind in the U.S. Other clinical trials using CRISPR to treat cancer use the technology to modify immune cells that have been removed from the body, then infuse the cells back into the patient.
If approved, Christiana Care is reportedly planning on recruiting six to 10 patients with late-stage, non-small-cell lung cancer. Researchers would target the patients' NRF2 genes by either injecting CRISPR directly into tumors or packaging it within adeno-associated viruses infused into the blood. Previous studies have shown that disabling NRF2 genes can slow down tumor cell proliferation and increase chemotherapy's effectiveness.
Researchers told STAT the study's goals will be "modest": The treatment will hopefully add a few more months to the lives of stage 3 and 4 cancer patients who have been told they only have about six months to live.
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