Statera Biopharma Says FDA Lifts Clinical Hold on Entolimod
By Michael Dabaie
Statera Biopharma Inc. said the U.S. Food and Drug
Administration lifted the clinical hold placed on Entolimod
research and development activity in acute radiation syndrome,
sending shares higher premarket.
Statera said that based on its response, the FDA acknowledged
that the company satisfactorily addressed historical regulatory
Statera shares rose about 6% to $3.11 in premarket trading.
Acute radiation syndrome, sometimes known as radiation toxicity
or radiation sickness, is an acute illness caused by a high dose of
penetrating radiation in a short period of time, according to the
U.S. Centers for Disease Control and Prevention.
"We are pleased that the FDA's clinical hold questions have been
successfully addressed, allowing us to continue our clinical work
in ARS and explore new indications for Entolimod in hematology,
specifically treatment of neutropenia and anemia in cancer
patients," said Statera Chief Executive Michael K. Handley.
Based on the data demonstrating efficacy and safety in acute
radiation syndrome, Statera said it intends to evaluate ongoing
development requirements and medical needs for Entolimod.
In addition, Statera is establishing a development program in
oncology and hematology based on the potential that toll-like
receptor 5 agonists, such as Entolimod, have shown in the treatment
of neutropenia and anemia in cancer patients.
Statera said discussions are underway with a U.S. academic
institution to initiate the first study of Entolimod in this new
area of focus in 2022.
Write to Michael Dabaie at email@example.com
(END) Dow Jones Newswires
December 01, 2021 08:16 ET (13:16 GMT)
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