Proteonomix,
Inc. (OTC/BB: PROT), a biotechnology company focused on developing
therapeutics based upon the use of human cells and their derivatives,
today announced that the U.S. Food and Drug Administration (FDA) has
granted permission to the Company to initiate a Phase 1 clinical trial
with its mobilization technology UMK-121. The Proteonomix-sponsored
trial will evaluate UMK-121 in patients with end-stage liver disease
(ESLD).
"Permission by the FDA marks an important milestone in our plans to
initiate a Company-sponsored clinical trial with UMK-121, following
years of research and investment to advance development of this drug
candidate," said Proteonomix Chief Technology Officer Steven Byle. "We
hope and anticipate that this trial will demonstrate the potential of
UMK-121 to mobilize stem cells in order to improve liver function in
patients with ESLD. We consider ourselves fortunate to be involved with
a development-stage therapy that could improve the life expectancy for
this class of terminally ill patients awaiting liver transplants."
Proteonomix CEO Michael Cohen added, "This is a significant step for our
Company as this is the first FDA IND to be held by Proteonomix and
demonstrates the ability of the Company to move basic research projects
into clinical trials."
Study reveals liver-brain communication as key to managing circadian eating patterns and obesity