June 18 (Reuters) - The U.S. health regulator has placed
three studies of Zentalis Pharmaceuticals' ( ZNTL ) cancer drug
on partial clinical hold following the death of two trial
participants, the company said on Tuesday.
Shares of the drug developer slumped about 26% to $6.22 in
early trading.
The drug candidate, azenosertib, was being tested against
solid tumors in an early-stage study and in patients with a type
of ovarian and uterine cancer in two mid-stage studies.
"We don't think this is the end for azenosertib,"
Oppenheimer analyst Matthew Biegler said, adding that the hold
is resolvable with enhanced patient monitoring and
preventatives.
While dosing for participants already enrolled will
continue, further enrollments in the mid-stage studies have been
paused, the company said.
The resolution of the partial clinical hold is necessary to
continue the development of azenosertib as a monotherapy, CEO
Kimberly Blackwell said on a conference call, adding that other
studies testing the drug in combination can continue.
The regulator's decision comes after two patients in the
ovarian cancer study died due to presumed blood-related
infection associated with the treatment, the company said.
Azenosertib belongs to a class of drugs that inhibit a
protein called WEE1, which may be found in higher-than-normal
amounts in some types of cancer cells.
Zentalis said it plans to share additional efficacy and
safety data for azenosertib from the ovarian cancer trial later
this year, adding that it is working with the Food and Drug
Administration to resolve the clinical hold.