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***PKTX...ProtoKinetix AAGP® Exhibits Efficacy and Safety in Model of Dry Eye Disease
Marietta, Ohio, April 6, 2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX), a clinical-stage biomedical company, having recently announced filing for patent protection for new applications of its AAGP® (PKX-001) molecule, announces preliminary results in efficacy and safety for use in treating Dry Eye Disease (DED).
PKX-001 demonstrates a protective effect in the murine model of dry eye disease. The effect of 5% PKX-001, delivered QID via bilateral topical administration, was evaluated in an acute murine model of desiccating stress (DS). The study was conducted by EyeCRO LLC (Oklahoma City, US). Corneal permeability was assessed by Oregon Green Dextran (OGD). CsA-MiDROPS™ significantly reduced DS-induced corneal permeability. PKX-001 reduced the DS-induced corneal permeability to the same level as the positive control CsA-MiDROPS. Additional tests are currently ongoing.
PKX-001 has a favorable in vitro and in vivo safety profile. PKX-001 safety upon ocular administration was evaluated in two animal models. The first study was conducted by ITR Laboratories (Montreal, Canada). PKX-001 formulated in BSS at a concentration up to 10% was not considered an eye irritant.
The second study was performed by EyeCRO LLC (Oklahoma City, US). Treated eyes were scored for chemosis, hyperemia and discharge on a daily basis. PKX-001 was well tolerated and not considered an eye irritant.
Furthermore, PKX-001 was negative in the bacterial reverse mutation assay and did not induce chromosomal damage in the micronucleus test in animal model ovary cells (ITR laboratories, Montreal, Canada).
PKX-001 demonstrated anti-inflammatory and cytoprotective properties: Reduced levels of anti-inflammatory cytokines Decreased oxidative stress Increased cellular survival and improved functional activity under various stress conditions
“These positive results in efficacy and safety in the recent testing of our AAGP® for dry eye disease is extremely promising for the future of using our molecule to treat this disease.” - said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix. “We are currently planning to move forward with the next stages of development ourselves.”
Market Overview According to market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately USD 4.5 billion in 2018, and the market is expected to reach up to USD 6.2 billion by 2024, with an anticipated CAGR of 5.23%, during the forecast period (2019-2024). The growth of dry eye related diseases may include several factors, such as aging, a decrease in the supportive hormones, systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion.
Dry Eye Disease is one of the most common ocular problems with an estimated prevalence of almost five million people over the age of 50 in the United States alone. Cyclosporine A is the first prescription product for dry eye therapy, which increases tear production in patients whose tear production is suppressed. However, Cyclosporine A treatment presents disadvantages over the long term which could potentially be mitigated by AAGP®.
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