Marietta, Ohio, November 23, 2021 – ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB: PKTX), a clinical-stage biomedical company, today announced that it has selected two formulations of its Anti-Aging Glycopeptide (AAGP®) product to be advanced into preclinical efficacy testing for the topical treatment of dry eye disease and ocular inflammation.
The selection follows a seven-month formulation development program conducted by Catalent, in which the Active Pharmaceutical Ingredient (API) was screened for ideal formulation conditions, with a number of potential excipients, to come up with a drug product that suits ProtoKinetix’s needs. The efficacy testing will be conducted by EyeCRO of Oklahoma City. This study should be completed by mid to late January 2022. The resulting lead formulation will then undergo extensive Good Laboratory Practice (GLP) toxicology examination, to prepare a submission for the U.S. FDA for its approval to conduct clinical trials.
“The relationship with Catalent has been extremely successful, and we believe this relationship will be ongoing for further development,” said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix. “This is a very exciting phase for the Company as it moves toward the commercialization phase in the Dry Eye Disease sector. The Company’s highest priority is to create stockholder value through the development and commercialization of products and delivery technology.”
ProtoKinetix is working on staffing key personnel to achieve our growing deliverables. This work incorporates retention of highly specialized personnel to advance the Company’s product commercialization plan. To secure regulatory approvals, this includes the execution of the required safety toxicology, clinical trials, and engagements. To achieve these goals, the Company is pleased to have expanded the roles of our advisor and consultant teams to add Dana Nohynek (Regulatory Affairs Consultant & Project Manager) and Christopher Santos (CMC Specialist), both specialists that continue to provide expertise, meeting Company needs for product development:
Their expertise will be essential to the management of the production of ProtoKinetix’s AAGP® product and regulatory agency formulation toxicology requirements near term (which will continue to be guided by the Company’s expert Toxicologist Consultant, Evelina Rubinchik, PhD). Along with the Company executives and medical science advisors, these specialists will inform and maintain our commercialization plan and industry partnerships.
Dry Eye Disease 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 compound annual growth rate (CAGR) of 5.8%, during the forecast period (2020-2025). The growth of dry eye related diseases may include several factors, such as a significant increase in the population aged 65 and older, a decrease in the supportive hormones, systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion.