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Press release: King Pharmaceuticals Initiates Phase II Clinical Trial Evaluating MRE0094 as a Treatment for Diabetic Foot Ulcers
Quote:
BRISTOL, Tenn., Jan. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that it has initiated the Company's Phase II
clinical trial program evaluating the safety and efficacy of its topical
investigational drug MRE094 in patients with chronic, neuropathic, diabetic
foot ulcers.
"We are very excited about the potential of MRE0094 as a safe and
effective treatment for chronic, neuropathic, diabetic foot ulcers. During
the course of our Phase I study in patients with this condition, we observed
no safety issues related to MRE0094 and noted positive effects on the rate of
wound closure," stated Michael K. Jolly, Pharm.D., Executive Vice President,
Research and Development, of King. "MRE0094 is a novel, adenosine A2A
receptor agonist that favorably affects the inflammation associated with these
ulcers by regulating the response of inflammatory cells and mediators, and by
enhancing the tissue proliferation phase of wound healing. By virtue of these
various mechanisms including endothelial cell proliferation and migration,
MRE0094 promotes tissue remodeling."
Dr. Jolly noted, "Diabetes is a major U.S. health concern affecting over
6% of the population. The incidence of diabetes is increasing at a rate of
approximately 1.3 million new cases diagnosed per year. With the increasing
prevalence of diabetes, the neuropathic, diabetic foot ulcer has become a
major physical, emotional, and economic burden affecting patients, families,
caregivers, and health systems. Approximately 15% of diabetic patients will
develop foot ulceration during the course of their disease." Dr. Jolly added,
"Hospital admissions of diabetic patients with neuropathic foot ulcers are
often prolonged by infection, gangrene, and lower extremity amputation."
Chronic, neuropathic, diabetic foot ulcers are a part of the wound healing
market which is estimated at greater than $3 billion in the United States.
The U.S. Food and Drug Administration has not yet evaluated the safety or
efficacy of MRE0094.
Adenosine A2A receptor agonist for diabetic foot ulcers
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