ProtoKinetix Announces Selection of AAGP® Candidate Formulations for Treatment of Dry Eye Disease

Rhea-AI Summary

ProtoKinetix, a clinical-stage biomedical company, has selected two formulations of its Anti-Aging Glycopeptide (AAGP®) for preclinical efficacy testing aimed at treating dry eye disease and ocular inflammation. The testing will be conducted by EyeCRO in Oklahoma City, expected to finish by mid-January 2022. Following this, the lead formulation will undergo GLP toxicology assessments for FDA submission. The company emphasizes its commitment to stockholder value creation and is enhancing its team with specialized consultants to support product commercialization and regulatory compliance.

Positive

• Selected two AAGP® formulations for preclinical efficacy testing for dry eye disease.
• Collaboration with Catalent has yielded successful formulation development.
• Potential market growth in dry eye disease sector, projected to reach USD 6.2 billion by 2024.

Negative

• None.

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.

About ProtoKinetix, Incorporated

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211123005532/en/

Clarence E. Smith

President and Chief Executive Officer

Telephone: 740-434-5041

Email: csmith@protokinetix.com

Twitter: @ProtoKinetix

Source: ProtoKinetix, Incorporated

FAQ

What recent development did ProtoKinetix announce regarding its AAGP® product?

ProtoKinetix announced the selection of two AAGP® formulations to advance into preclinical efficacy testing for dry eye disease.

When is the preclinical efficacy testing for AAGP® scheduled to be completed?

The preclinical efficacy testing is expected to be completed by mid to late January 2022.

What is the expected market growth for dry eye disease treatment?

The dry eye disease market is expected to grow from approximately USD 4.5 billion in 2018 to USD 6.2 billion by 2024.

Who is conducting the efficacy testing for ProtoKinetix's AAGP® product?

The efficacy testing will be conducted by EyeCRO, based in Oklahoma City.

What role do the newly appointed consultants play at ProtoKinetix?

The new consultants will aid in regulatory affairs and project management to support product development and compliance.