MARIETTA, Ohio--(BUSINESS WIRE)--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.
Cautionary Note Regarding Forward-Looking Statements
The information discussed in this press release includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included herein concerning, among other things, planned capital expenditures, future cash flows and borrowings, pursuit of potential acquisition opportunities, our financial position, business strategy and other plans and objectives for future operations, are forward looking statements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, they do involve certain assumptions, risks and uncertainties and are not (and should not be considered to be) guarantees of future performance. Refer to our risk factors set forth in our reports filed on Edgar. ProtoKinetix disclaims any obligation to update any forward-looking statement made here.
This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States.