8 April 2020 - - US-based clinical-stage biomedical company ProtoKinetix, Inc. (OTCQB: PKTX) having recently announced filing for patent protection for new applications of its AAGP (PKX-001) molecule, has released preliminary results in efficacy and safety for use in treating Dry Eye Disease, the company said.

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. The study was conducted by EyeCRO LLC (Oklahoma City, US).

Corneal permeability was assessed by Oregon Green Dextran. 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 favourable 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, including reduced levels of anti-inflammatory cytokines, decreased oxidative stress and increased cellular survival and improved functional activity under various stress conditions.

According to market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately 4.5bn in 2018, and the market is expected to reach up to 6.2bn 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 5m 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.

ProtoKinetix is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP) that enhance both engraftment and protection of transplanted cells, tissues and organs used in regenerative medicine.

Due to the results achieved over the last four years of testing, the University of Alberta has begun Phase 1 human clinical trials.