Curis Says FDA Places Partial Hold on Lymphoma Study
11 April 2022 - 10:56PM
Dow Jones News
By Michael Dabaie
Curis Inc. said Monday the U.S. Food and Drug Administration
placed a partial clinical hold on the company's TakeAim Lymphoma
study, a Phase 1/2 trial of emavusertib in patients with B-cell
malignancies.
The cancer-focused biotechnology company said this FDA
notification from the FDA Division of Hematologic Malignancies 2,
which regulates clinical studies in lymphoma, is separate from the
notification previously received from the FDA Division of
Hematologic Malignancies 1, which regulates clinical studies in
leukemia.
Curis in early April said the FDA placed a partial clinical hold
on the TakeAim Leukemia study.
Monday's notification extends the partial hold across both
studies. "This is not unexpected, as both studies treat patients
with emavusertib," the company said.
Shares fell 2%, to $1.41, premarket.
The company said it had already voluntarily paused enrollment in
the TakeAim Lymphoma study in connection with the partial clinical
hold on the Leukemia study.
"We reiterate our previous comments: we are committed to
ensuring the safety of patients in our studies and to working
collaboratively with the FDA to develop therapies that meaningfully
improve and extend patients' lives," said Chief Executive James
Dentzer. "Given the clinical profile of emavusertib observed to
date, we are hopeful that the study can be resumed soon, after
appropriate review. We continue to be confident in the potential of
emavusertib to address the high unmet need of patients with B-cell
cancers, AML, or MDS."
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
April 11, 2022 08:41 ET (12:41 GMT)
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