Genkyotex Announces Update for Near Term Clinical Development Plan for Setanaxib
(Paris:GKTX) (Brussels:GKTX)
(Euronext Paris Brussels: FR0013399474 GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced clinical and governance updates.
Clinical update
Following the positive results from the Phase 1 study announced in January of 2021, which evaluated higher doses of setanaxib in healthy subjects, Genkyotex is planning to initiate a pivotal Phase 2/3 study in primary biliary cholangitis (PBC), starting in the 2
nd half of 2021, with final design and protocol details subject to feedback from the US Food and Drug Administration (FDA).
In addition, the Company plans to initiate this year a Phase 2 proof-of-concept study in patients with head and neck cancer. The trial will evaluate administration of setanaxib, targeting cancer associated fibroblasts (CAFs), in conjunction with immunotherapy.
CHICAGO A recently released study shows that a multimodal pain regimen (MMPR) designed to minimize opioid exposure and relieve acute pain associated with traumatic injury kept patient self-reported pain scores low while also reducing the daily and total amount of opioid drugs given to trauma patients.
Results from the first study of its kind to evaluate an MMPR in a rigorous, randomized controlled trial were published online as an “article in press” by the
Journal of the American College of Surgeons in advance of print.
“Opioids should not be considered the pillar of treatment for acute pain after injury,” said lead study author John A. Harvin, MD, FACS, associate professor for the department of surgery, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth) and trauma surgeon at the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center.