ROCKVILLE -
Completion of treatment and follow-up for the last subject is anticipated to be by the end of
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 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.
This year, GtreeBNT announced that it has secured additional major intellectual property rights, including patents related to composition, formulation, and manufacturing of RGN-259 eye drops, and that RGN-259 has recently been reclassified as a biologic requiring a Biologics License Application (BLA), rather than an New Drug Application (NDA), conferring 12 years of market exclusivity when the product is approved by FDA.
About
ReGenTree is a
About
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (T4) and its constituent fragments for tissue and organ protection, wound repair, and tissue regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/TBI and dermal indications, four active strategic licensing agreements in the
Forward Looking Statements
Any statements in this shareholder letter that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Forward-looking statements in this press release include, but are not limited to, competitive products, statements from us or our joint venture partner regarding strategic and research partnerships, status of clinical trials, regulatory applications and approvals, the development and value of our drug candidates, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any clinical trial will be successful or confirm previous clinical results. Please view these and other risks described in the Company's filings with the
Contact:
Tel: 301.208.9191
Email: las@regenerx.com
(C) 2020 Electronic News Publishing, source