ReGen Factor Announces Planned Submission of Pre-IND Meeting Package for Innovative Diabetic Ulcer Healing Treatment
Sydney, Australia – July 3, 2024 – ReGen Factor, a leader in advanced R&D skin biology, proudly announces the planned submission of a comprehensive Pre-Investigational New Drug (Pre-IND) meeting package to the U.S. Food and Drug Administration (FDA) within the next 30 to 60 days for its pioneering treatment for diabetic ulcers. This innovative therapy, which utilizes recombinant human basic fibroblast growth factor (rh-bFGF) suspended in Aqueous cream, aims to revolutionize the management of diabetic foot ulcers.
Summary of the Planned Pre-IND Package
The planned Pre-IND meeting package includes a thorough presentation of the treatment’s clinical background, pharmacology, toxicology, chemistry, manufacturing, controls, and development plans. Key highlights of the package include:
- Clinical Background and Rationale:
- Comprehensive data on the efficacy of rh-bFGF in promoting wound healing, supported by numerous studies and clinical trials.
- A comparison of rh-bFGF with other FDA-approved wound healing agents such as Integra Omnigraft, Dermagraft, and Apligraf, showcasing the superior healing potential of rh-bFGF.
- Pharmacology and Pharmacokinetics:
- Detailed in vitro and in vivo pharmacology data, including graphical representations of pharmacokinetics and pharmacodynamics.
- Specific numerical values for pharmacokinetic parameters, such as half-life, Cmax, and AUC.
- Clinical Development Plan:
- A meticulously detailed clinical plan, including study endpoints, statistical analysis plans, and descriptions of study centres and principal investigators.
- Specific primary and secondary endpoints and statistical methods to ensure robust data analysis.
- Toxicology Studies:
- Comprehensive summaries of animal toxicology studies, including methodologies, key findings, and statistical significance.
- Detailed summaries of single-exposure ocular and skin irritation studies, acute oral and dermal toxicity tests, and skin sensitization studies.
- Chemistry, Manufacturing, and Controls:
- Detailed fermentation protocol, purification process, and quality control measures, ensuring the highest purity and potency of rh-bFGF.
- Stability testing and shelf-life data, demonstrating the product’s reliability under various conditions.
- Development Plans:
- Detailed timelines and milestones, illustrated with a Gantt chart to visualize the progression from preclinical stages to commercial production.
Objectives of the Planned Pre-IND Meeting
The planned Pre-IND meeting aims to achieve the following objectives:
- Confirm the acceptability of the proposed clinical trial design and endpoints.
- Obtain FDA feedback on the overall development plan and regulatory strategy.
- Discuss the proposed manufacturing process and controls to ensure compliance with FDA requirements.
- Address any potential safety concerns and clarify the toxicology study results.
ReGen Factor is an Australia-based progressive R&D skin biology company dedicated to developing first-to-market technology for bio-identical and cost-effective fibroblast growth factors (FGFs). Our products aim to make a global impact in the cosmetic, cosmeceutical, and pharmaceutical industries by leveraging our expertise in skin biology and commitment to innovation.
For further information, please contact:
Media Contact
Claire Ironside – Media Consultant ReGen Factor
Phone: +61 2 8916 6220
Email: info@pepfactor.org
Website: www.regenfactor.org
