ROCKVILLE, Md., June 14, 2016 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced a publication of a pilot clinical trial demonstrating that Thymosin beta 4 (Tβ4) was effective in the treatment of patients after an acute ST segment elevation myocardial infarction (STEMI), or heart attack
The trial was designed to study whether endothelial progenitor cells (EPCs or immature cells) treated with Tβ4 and transplanted into STEMI patients would improve cardiac and clinical function compared to a control group. Ten patients with STEMI were included; they were randomized to 2 groups: a Tβ4-pre-treated EPC transplantation group (experimental group; n = 5) and an EPC transplantation group (control group; n = 5). EPCs were pre-treated with Tβ4 24 hours before transplantation in experimental group.
Cardiac function was evaluated using echocardiography and emission computed tomography, as well as the 6-min walking test before and 6 months after the intervention. After 6 months, the left ventricular ejection fraction based on two different measurements improved by more than 50% (p<0.05), and the stroke volume, amount of blood ejected by the left ventricle, improved by approximately 50% ((p<0.05) in the Tβ4-pre-treated group. After 6 months of follow-up, the average 6-min walking distance was improved by 14% (p<0.01). There were no severe complications related to the procedure in either group during the follow-up.
"The pilot study, the first human study conducted with Tβ4 in patients following a heart attack, demonstrates the potential clinical benefits of Tβ4 in repairing and regenerating damaged tissue and improving cardiac function. This important advance not only elaborates on data generated in previous animal studies, but also reflects the need to conduct larger clinical trials with Tβ4 in these patients," stated Dr. Alan Wasserman, cardiologist and Eugene Meyer Professor and Chairman, Department of Medicine, the George Washington University Medical School.
The independent study was conducted by Junhui Zhu and his colleagues in Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China and published in International Society for Cellular Therapy, http://dx.doi.org/10.1016/j.jcyt.2016.05.006.
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 in the U.S. and Canada. RGN-259, the Company's Tβ4-based ophthalmic drug candidate is being developed for dry eye syndrome and for the treatment of neurotrophic keratopathy (NK), both of which are being developed in the U.S and Canada through its joint venture, ReGenTree. ReGenTree has reported results of its recently completed Phase 2/3 U.S. trial in patients with dry eye syndrome and is conducting a Phase 3 clinical trial for the treatment of patients with NK, for which it has been granted orphan status by the U.S. FDA. RGN-352, the Company's Tβ4-based injectable drug candidate, 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 injuries. RGN-137, the Company's Tβ4-based dermal gel, is in phase 2 clinical development. For additional information about RegeneRx please visit www.regenerx.com.
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. There can be no assurance that any clinical trial results, including results from this study, will be confirmed in any future clinical trials or will result in approved products or future value. 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, 2015, 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.
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SOURCE RegeneRx Biopharmaceuticals, Inc.