The U.S. Food and Drug Administration lifted its hold on CRISPR Therapeutics and Vertex Pharmaceuticals’ highly anticipated gene-editing trial Wednesday, allowing the first company-backed trial using the CRISPR/Cas9 technology to start in the U.S.
CRISPR and Vertex were preparing to test the the ability of a new gene-editing technology, CRISPR/Cas9, in cutting out and replacing disease-causing snippets of DNA when the FDA placed the hold in May. The trial is scheduled to start by the end of 2018, according to a joint statement from the companies.
The experimental technology has not yet been tested in humans and has raised safety concerns in the industry. However, European regulators allowed the companies to launch a clinical trial August.
Memphis-based St. Jude Children’s Research Hospital includes a Center for Advanced Genome Engineering, which “provides expertise and infrastructure for St. Jude investigators to educate, assist, expedite and perform established and emerging genome engineering technologies, including the CRISPR-Cas9 technology,” St. Jude says on its website.
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CRISPR’s stock jumped when trading re-opened after the announcement, with the shares up nearly 6 percent as of 11 a.m. Friday. Shares of Vertex, which already has multiple FDA-approved drugs for cystic fibrosis, dipped slightly.
CRISPR is one of three publicly traded startups based in Cambridge, Massachusetts, that is focused on CRISPR/Cas9. The others are Editas Medicine and Intellia Therapeutics.
Date: October 23, 2018
Source: Bizjournal