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Ampio Awarded US and Canadian Patents that will Bolster the Commercialization of Optina™ for the treatment of Diabetic Macular Edema (DME)
Date:4/27/2012

a™ involves the remodeling of the actin cytoskeleton (F-actin) of endothelial cells (cells that line the inside of blood vessels, including the retinal blood vessels) so that the adhesion molecules between these cells are tightly bound to the peripheral actin (cortical) resulting in tighter junctions among these cells, hence preventing vascular leakage from the blood compartment into tissue. The basic mechanism of action of Optina™ is described in a recently published manuscript entitled: "Biphasic effect of danazol on human vascular endothelial cell permeability and f-actin cytoskeleton dynamics" in Biochemical Biophysical Research Communications (BBRC 21 April 2012 http://dx.doi.org/10.1016/j.bbrc.2012.04.066). This is the first in a series of publications describing the biphasic effect of danazol on vascular permeability which is beneficial in reducing permeability (nano molar concentrations) and increasing permeability at the higher concentrations used in other approved indications (micro molar).

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted, "A clinical study of Optina™ for DME conducted in a double masked, placebo controlled manner at Saint Michael Hospital in Toronto, Canada, confirmed the in vitro findings that the ultra-low dose of danazol is beneficial while the high dose is detrimental. Complete analysis of the Optina™ trial is underway by our CRO and results will be published in the proper venues following a pre-IND meeting with the FDA. Ampio is preparing for a pre-IND meeting with the FDA to discuss plans for a pivotal trial(s) in the US under the 505(b)2 registration."

About Diabetic Retinopathy, Diabetic Macular Edema and current treatments
Diabetic retinopathy is damage to the retina of the eyes caused by complications of diabetes mellitus and often resulting in loss of visual acuity and blindness.  Macular edema of th
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SOURCE Ampio Pharmaceuticals, Inc.
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