ROCKVILLE, Md., Oct. 23, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or the "Company"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today is providing an update on the status of its ophthalmic clinical program in China and Korea.
Lee's Pharmaceutical Ltd., RegeneRx's licensee in China, Hong Kong, Macau and Taiwan, received notice from China's FDA (CFDA) declining its investigational new drug (IND) application for a Phase 2b dry eye clinical trial because the API (active pharmaceutical ingredient or TB4) was manufactured outside of China. The API was manufactured in the U.S. and provided to Lee's by RegeneRx pursuant to a license agreement to develop RGN-259 ophthalmic eye drops in the licensed territory.
Due to this unexpected regulatory hurdle, Lee's plans to modify its clinical program to conduct the Phase 2b dry eye trial in Hong Kong and Taiwan using the TB4 supplied by RegeneRx while awaiting the manufacturing of TB4 in China for a subsequent Phase 3 registration trial. Start of the Hong Kong/Taiwan trial is expected in the first half of 2016. Under this revised strategy, Lee's believes it should be able to begin a Phase 3 registration trial in China sooner rather than waiting on the production of TB4 in China for the Phase 2b trial.
G-treeBNT, RegeneRx's licensee in Korea, Australia, Japan and a number of other countries in Asia, recently received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase 2b/3 clinical trial for dry eye syndrome in Korea. Given its immediate focus on the two U.S. trials, G-treeBNT is considering the best timing for the Korean trial.
"Both U.S. ophthalmic trials are moving forward as expected, and we are pleased Lee's is quickly moving their Phase 2b trial to Hong Kong and Taiwan using the U.S.-produced TB4 while they separately manufacture it in China to satisfy the CFDA. We agree with their clinical strategy and support them. Similarly, we support G-tree's timing considerations in Korea while they utilize their resources to ensure the U.S. clinical trials continue to progress according to plan," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.
RegeneRx recently announced that its U.S. Phase 2b/3 dry eye clinical trial, conducted by Ora Inc., has enrolled over 125 of 350 patients in the first month and its U.S. Phase 3 neurotrophic keratopathy trial, a smaller study in an orphan population, has enrolled several patients to date. Both trials are expected to be completed in early 2016 and report data shortly thereafter.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the U.S., and has worldwide patents and patent applications covering its products. RGN-259, the Company's TB4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK). RegeneRx has Phase 3 clinical trials with RGN-259 for the treatment of patients with NK. The drug candidate is also being tested in patients with dry eye syndrome in the U.S. and Asia. RGN-352, the Company's TB4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar traumatic injuries. For additional information about RegeneRx please visit www.regenerx.com.
RGN-259 (designated GBT-201 in Korea) is a sterile, preservative-free eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4). Based on U.S. Phase 2 clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. The data from these trials, as well as a recently completed clinical trial of RGN-259 in patients with neurotrophic keratopathy, reflect RGN-259's mechanisms of action, support the "protective" effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials. Dry eye syndrome is a multifactorial disease and it is well known that TB4 promotes cell migration and proliferation, modulates cytokines and/or chemokines related to inflammation, matures stem cells, and stimulates cell survival, all of which are believed to be important for effective treatment of DES.
Any statements in this press release 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 used in this press release relate to, among other things, the expected procedure, timing and results of clinical trials in the United States, Korea, China, Hong Kong, and Taiwan, and the potential benefits to RegeneRx of such trials. There can be no assurance that any clinical trial will start or complete within the estimated timeframe or that positive results from any clinical trial or research by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2014, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
SOURCE RegeneRx Biopharmaceuticals, Inc.