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Press Release

May 20, 2022
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FDA places partial hold on trial for patients with AML, myelodysplastic syndrome

Source:

Press Release

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The FDA placed a partial clinical hold on a phase 1 dose-escalation study of a therapy under investigation for certain patients with blood cancer.

The trial is designed to assess FHD-286 (Foghorn Therapeutics) for patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. The agent is a small-molecule enzymatic inhibitor of BRG1 and BRM, two proteins that promote cancer cell growth.

FDA headquarters
Source: Adobe Stock.

The FDA initiated the partial clinical hold after learning a study participant with potential differentiation syndrome had died.

“Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on target for the proposed mechanism of action for FHD-286,” a Foghorn Therapeutics-issued press release read. “The FDA requested a review of the safety database, risk mitigation strategies and a breakdown of clinical activity across dose levels.”

Study participants who are deriving benefit from FHD-286 may continue to receive treatment; however, no new patients can be enrolled until the partial hold is resolved.

The FDA’s action does not affect a phase 1 dose-escalation study of FHD-286 for patients with metastatic uveal melanoma.

“Patient safety remains our top priority. We appreciate the dialogue with the FDA and will work diligently with the agency to resolve the partial clinical hold in AML/MDS as soon as possible,” Adrian Gottschalk, CEO of Foghorn Therapeutics, said in the release.