ProtoKinetix Announces Selection of AAGP庐 Candidate Formulations for Treatment of Dry Eye Disease
The selection follows a seven-month formulation development program conducted by 探花合集, 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鈥檚 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.
鈥淭he relationship with 探花合集 has been extremely successful, and we believe this relationship will be ongoing for further development,鈥 said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix. 鈥淭his is a very exciting phase for the Company as it moves toward the commercialization phase in the Dry Eye Disease sector. The Company鈥檚 highest priority is to create stockholder value through the development and commercialization of products and delivery technology.鈥
ProtoKinetix is working on staffing key personnel to achieve our growing deliverables. This work incorporates retention of聽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鈥檚 AAGP庐 product and regulatory agency formulation toxicology requirements near term (which will continue to be guided by the Company鈥檚 expert Toxicologist Consultant, Evelina聽Rubinchik, PhD). Along with the聽Company聽executives and medical science advisors,聽these specialists will inform and maintain our commercialization plan and industry partnerships.
To find out more information about ProtoKinetix, visit
ABOUT CATALENT
探花合集 is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.
With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, 探花合集 is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. 探花合集 helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually.
探花合集鈥檚 expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit .