공고 • 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. 공고 • 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. 공고 • 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. 공고 • 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. 공고 • 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. 공고 • Dec 19
RegeneRx Biopharmaceuticals, Inc. Announces U.S. FDA Accepts Request for Pre-BLA meeting Pursuant to RGN-259 RegeneRx Biopharmaceuticals, Inc. announced that the U.S. FDA has accepted its request for a pre-BLA meeting pursuant to RGN-259, its novel product candidate for dry eye syndrome. The meeting is scheduled for February 28, 2022. A BLA (Biologics License Application) is FDA's standard full approval mechanism for biological products, including therapeutics and vaccines. The purpose of the pre-BLA meeting is to discuss with FDA the format, content, and acceptability of the anticipated BLA application. The Sponsor (ReGenTree LLC) will provide the briefing document to the agency prior to the meeting that will include a review of clinical studies, non-clinical studies, CMC (manufacturing) requirements, and previous meeting minutes between RegeneRx, ReGenTree and FDA. 공고 • Mar 19
RegeneRx Biopharmaceuticals, Inc. Reports Topline Results of ARISE-3 Dry Eye Trial RegeneRx Biopharmaceuticals, Inc. announced that the ARISE-3 Phase 3 clinical trial evaluating RGN-259 eyedrops for the treatment of dry eye syndrome did not meet its primary outcome measures. However, efficacy was seen in the improvement of ocular grittiness, one of the pre-specified secondary symptom endpoints in the trial. The statistically significant improvement was seen at one and two weeks after treatment, and post-exposure in a controlled adverse environment after two weeks of treatment with RGN-259 compared to placebo (p=0.0104, 0.0307, and 0.0046, respectively). RGN-259 continued to demonstrate safety in treatment of dry eye syndrome consistent with previous clinical trials. In the ARISE-3 trial, there were no serious adverse events with only mild to moderate adverse events in both the active and placebo arms. The most common ophthalmic adverse event was mild ocular pain upon instillation (RGN-259 6.6% vs. placebo 4.6%). Based on preliminary post-hoc analyses by GtreeBNT using all of the patients in the three phase 3 trials, the population compromised by a corneal sum fluorescein staining score showed significant improvement in sign efficacy parameters such as fluorescein staining scores in the central, corneal sum, conjunctival sum, and total sum after two weeks of treatment. Additional analyses are being conducted to define efficacies in various sign and symptom parameters using the pooled data of the three phase 3 trials. Comprehensive results will be released when all the data analyses are completed. Data analysis is expected to be focused on the fast on-set and multifunctional effects of RGN-259 that were shown in all three clinical trials. Based on these results, GtreeBNT and RegeneRx will explore the prospects of a pre-BLA meeting with the FDA using the pooled data or discuss a detailed plan for additional clinical studies, if needed. 공고 • Feb 25
RegeneRx JV Locks Clinical Trial Database for Phase 3 Dry Eye Trial RegeneRx Biopharmaceuticals, Inc. announced that the ARISE-3 Phase 3 clinical trial database evaluating RGN-259 eyedrops for the treatment of dry eye syndrome has been locked after collecting and verifying patient data from 20 U.S. clinical sites participating in the study. Database lock is a specific time point prior to unmasking the trial and after which no patient information may be modified.
ReGenTree LLC, the U.S. joint venture company owned by RegeneRx Biopharmaceuticals, Inc. and GtreeBNT, a Korean biopharmaceutical company, is sponsoring the clinical trial and will unmask the study and begin the biostatistical analysis that will include not only primary endpoints, but also other pre-specified endpoints identified in the clinical protocol. GtreeBNT has previously stated that it has secured major intellectual property rights, including patents related to composition, formulation, and manufacturing process for RGN-259 eye drops. Last year RGN-259, a 43 amino acid peptide, was reclassified from a new chemical entity to a biologic by the FDA. Thus, it will require a Biologics License Application (BLA), rather than a New Drug Application (NDA) for marketing approval and receive 12 years of market exclusivity in the U.S. if the product is approved by the FDA. GlobalData, a well-known market research publisher worldwide, estimated that the dry eye market will reach $11.1 billion in 2028 in 9 major countries including the U.S. according to its market research report published in May 2020. Also, GlobalData expects that due to RGN-259's unique mechanism of action (MOA), it would garner significant market share during the forecast period after its market launch. 공고 • Nov 10
RegeneRx Biopharmaceuticals, Inc. Announces Last Patient, Last Visit Completed in RegeneRx Phase 3 Dry Eye Clinical Trial RegeneRx Biopharmaceuticals, Inc. announced that the final patient in its 700 subject, ARISE-3 phase 3 clinical trial for dry eye syndrome has completed treatment and follow-up. The ARISE-3 trial is being sponsored by ReGenTree, LLC, a U.S. joint venture company owned by RegeneRx and G-treeBNT, a Korean biopharmaceutical company. ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome. RGN-259 is a proprietary eye drop that, to date, has demonstrated fast onset efficacy in two previous phase 3 clinical trials, "ARISE-1" and "ARISE-2", is safe and well-tolerated, and has not shown any adverse side effects such as eye irritation, stinging, visual disturbance, etc., unlike currently approved products. 공고 • Oct 15
RegeneRx Biopharmaceuticals, Inc. Announces ARISE-3 Phase 3 Trial Completion Expected by End of 2020 RegeneRx Biopharmaceuticals, Inc. announced that enrollment in the 700-patient, phase 3 clinical trial for dry eye syndrome (ARISE-3) is expected to be completed in November, 2020, and that the estimated study completion date and collection of data for the primary and secondary outcome measures will be in December, 2020.