ProtoKinetix AAGP Exhibits Efficacy and Safety in Model of Dry Eye Disease
ProtoKinetix, which recently announced filing for patent protection for new applications of its AAGP (PKX-001) molecule, announced preliminary results in efficacy and safety for use in treating dry eye disease (DED).
PKX-001 demonstrated a protective effect in the murine model of dry eye disease, according to a company news release. 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). 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.” Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix, said in a company news release. “We are currently planning to move forward with the next stages of development ourselves.”