공시 • Feb 01
Thymosin Beta 4 Research Leads Toward Potential Future Anti-Aging Therapy RegeneRx Biopharmaceuticals, Inc. is reporting a new scientific publication describing Thymosin beta 4's (T<BETA>4) potential as an anti-aging therapy. Using the heart as a model experimental system, a research team from Hungary and the United States summarized and expanded upon their previous results regarding Thymosin beta 4 (T<BETA>4) to support their anti-aging hypothesis. They investigated the developmental expression of T<BETA>4 in mouse embryos and determined the impact of the molecule in adult animals by systemically injecting the peptide following acute cardiac infarction (heart attack) compared to no myocardial injury. Their research proved that T<BETA>4 is expressed in the developing heart and promotes cardiac cell migration and survival. In adult animals, the peptide enhanced myocyte survival and improved cardiac function after coronary artery ligation (surgically blocking the artery to induce injury). Intravenous injections of T<BETA>4 altered the structure of the adult epicardium (heart), and the changes resemble the characteristics of the embryo by increasing number of cardiac vessels and by the alteration of the gene expression profile typical of the embryonic state. Finally, the researchers discovered T<BETA>4 is capable of epicardial progenitor activation, and revealed the effect is independent of hypoxic injury. 공시 • Jan 04
Regenerx Biopharmaceuticals, Inc. Reports New Scientific Publication of RGN-259 Phase 3 Clinical Trial Results in Patients with Neurotrophic Keratopathy RegeneRx Biopharmaceuticals, Inc. reported a new scientific publication describing the safety and efficacy of RGN-259 eyedrops in a phase 3 clinical trial in patients with Neurotrophic Keratopathy (NK). The product candidate is being developed by ReGenTree, LLC, a U.S. joint venture between RegeneRx Biopharmaceuticals and HLB Therapeutics. The study determined the efficacy and safety of RGN-259 in promoting the healing of persistent epithelial defects in patients with Stage 2 and Stage 3 NK. Complete healing occurred after 4 weeks in 6 of 10 RGN-259-treated subjects and 1 of 8 placebo-treated subjects, indicating a strong efficacy trend. Additional statistically significant healing was observed at day 43, two weeks after cessation of treatment, with no recurrent defects. RGN-259-treated subjects had significant improvements at multiple time points in ocular discomfort, foreign body sensation, and dryness, which were not seen in the placebo group. No significant adverse effects were observed. About RGN-259: RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy. To date, over 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK. RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications. Thymosin beta 4, is the active pharmaceutical ingredient of RGN-259 that has demonstrated various mechanisms of action, including promotion of cell migration, cytoprotection, wound healing, and anti-inflammatory properties. 공시 • Oct 25
Regenerx Licensee Submits Special Protocol Assessment to Fda for 4Th Phase 3 Clinical Trial for Dry Eye Disease RegeneRx Biopharmaceuticals, Inc. reported that its U.S. joint venture (JV) partner and licensee, HLB Therapeutics (HLBT), has announced that it submitted a request for the Special Protocol Assessment (SPA) to the U.S. FDA for an in-depth discussion and assessment of the clinical protocol for a fourth phase 3 clinical trial (ARISE-4) for the treatment of dry eye disease. RGN-259 is a developed by ReGenTree, a U.S. joint venture company between RegeneRx Biopharmaceuticals and HLB Therapeutics. In accordance with SPA request have submitted to the FDA a briefing document summarizing ARISE-1, -2, and -3 clinical data, including efficacy parameters and questions related to the clinical development of RGN-259 dry eye, along with the ARISE-4 protocol and statistical analysis plan. It is expected that the detailed direction and agreement given by FDA in advance by using the SPA process will help the company's development strategy for the approval of RGN- 259. Considering the initiation of this process, expect that the ARISE-4 trial will begin around the second quarter of 2023, according to HLB Therapeutics. SPA is a process by which sponsors may request to meet with FDA to reach agreement on the design and size of certain trials, clinical studies, or animal studies to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. 공시 • May 05
RegeneRx Biopharmaceuticals, Inc. Reports that Researchers Demonstrate the Therapeutic Efficacy of Thymosin Beta 4 RegeneRx Biopharmaceuticals, Inc. reported that researchers have demonstrated the therapeutic efficacy of Thymosin Beta 4 (Tß4) as a combination treatment against hyperglycemia (diabetic)-induced changes in human corneal epithelial cells. The research was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022 meeting, held May 1-4, 2022, in Denver, Colorado. The research team included scientists and physicians from Wayne State University School of Medicine in Detroit, MI; the University of Central Florida College of Health Professors and Sciences in Orlando, FL; and Mansoura University in Mansoura, Egypt. The research was funded by the National Institutes of Health, the Eversight Center for Vision and Eye Banking Research, and Research to Prevent Blindness. 공시 • Jan 26
Researchers Confirm Thymosin Beta 4's Ability to Protect Eyes From Ethanol Injury RegeneRx Biopharmaceuticals, Inc. announced that Chinese researchers confirmed the ability of Thymosin beta 4 (Tß4) to protect corneal stromal cells from damage due to ethanol exposure and significantly promote wound healing. Ethanol is used in ophthalmic surgeries to sterilize the eye for surgeries such as LASEK and PRK and can cause damage such as apoptosis (cell death), inflammation, and extend healing time. The corneal stroma plays a significant role in maintaining corneal shape and curvature, and corneal transparency. Corneal stroma wound healing is a complex process and an efficient repair process is vital. The research team demonstrated the protective effects of using Tß4 in both in vivo and in vitro animal models. The research was published by Liu et al., in BMC Ophthalmology (2022) 22:33, https://doi.org/10.1186/s12886-022-02255-8. RGN-259 is a sterile, preservative-free eye drop with Tß4 as the active ingredient, that in controlled clinical trials has been shown to quickly reduce certain signs and symptoms of dry eye syndrome and neurotrophic keratitis and having no significant side effects that are commonly associated with other products. The product candidate has completed three phase 3 clinical trials in patients with dry eye syndrome and is moving through the FDA regulatory process through the Company's ReGenTree LLC U.S. joint venture. 
