Christiana Care seeks FDA approval for CRISPR cancer trial

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), the gene-editing tool, has been the subject of countless debates on the ethical use of a technology that can actually alter DNA — with some foreseeing a dystopia of custom-ordered babies and miniature giraffes as pets.

Less dystopian are the potential medical benefits of CRISPR, which is why the Christiana Care Health System’s Gene Editing Institute is in the process of developing its first clinical trial that would use CRISPR on patients, after conducting successful lab trials. (You can read the December 2018 proof of concept paper on Molecular Therapy Oncolytics.)

The institute recently filed a preliminary investigational new drug application (IND) with the U.S. Food and Drug Administration. If approved, the trial, which focuses on treatment of  KRAS-positive non-small cell lung cancer, would have cleared a major hurdle in starting the trial.

“This exciting study represents a trio of firsts,” said Nicholas J. Petrelli, M.D., FACS, medical director of Christiana Care’s Helen F. Graham Cancer Center & Research Institute, in a statement. “It will be the first lung cancer clinical trial carried out by a gene editing program embedded in a community cancer center. While our Gene Editing Institute has a great deal of translational research experience, this will be its first study to move scientific discovery toward an IND application.

“And, it will also be the first time that we will be investigating technology that was grown organically at the Gene Editing Institute.”

You can learn more about CRISPR here: