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Curis Drops; Lower Dose of Leukemia Drug to Reach Phase 2 Study

Curis said it would take a lower dose of its leukemia treatment into Phase 2 studies after higher doses showed toxicities.
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Shares of Curis (CRIS) - Get Report lost a third of their market value on Friday after the drugmaker said it would take a 300mg dose of its CA-4948 leukemia treatment into Phase 2 trials.

The 500 mg and 400 mg versions showed dose-limiting toxicities, the company statement said. 

Shares of the Lexington, Mass., company at last check dropped 37% to $8.

The updated data from the study "further support the growing body of evidence that CA-4948's anti-cancer activity continues to deepen the longer patients remain on drug, which is enabled by its safety and durability profile to date," Chief Executive James Dentzer said in a statement. 

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"Further, after backfilling patient cohorts and evaluating additional data after the April 30, 2021, cutoff date for today's presentation, we have concluded 300mg BID is the optimal dose to take into Phase 2 studies."   

Curis presented at the European Hematology Association 2021 Virtual Congress.

The reported data are from Curis's Phase 1/2 dose-escalation study for orally administered CA-4948, a monotherapy for adult patients with acute myeloid leukemia.

The primary endpoint of the study is to determine the maximum tolerated dose and recommended Phase 2 dose based on safety and tolerability.