The Night Stalker
14 years ago
This Article:
British Researchers Report that TB4 is Essential to Heart Development
Date : 08/02/2010 @ 8:30AM
Source : Business Wire
Stock : RegeneRx Biopharmaceuticals, Inc. (RGN)
Quote : 0.283 0.017 (6.39%) @ 4:15PM
British Researchers Report that TB4 is Essential to Heart Development
Regenerx Biopharm In (AMEX:RGN)
Historical Stock Chart
1 Month : July 2010 to August 2010
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the Company” or “RegeneRx”) today announced that a research team from the Molecular Medicine Unit at UCL-Institute of Child Health in London reported preclinical findings that Thymosin beta 4 (Tß4), is essential to healthy heart development and embryonic survival.
The research was conducted by Drs. Nicola Smart, Karina Dubé and Paul Riley, and was published online in Nature Communications; 2010 Jul 27; DIO 10.1038/ncomms1041. The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and the UCL-Institute.
In the study, mice embryos were genetically modified not to produce Hand1, a key transcription factor that plays a fundamental role in the normal development of the heart and in congenital heart disease. Without Hand1, Tß4 is down-regulated, hearts are malformed and the embryos do not survive. In this study, injection of synthetic Tß4 into pregnant female mice lacking Hand1 resulted in normal development and in the survival of the early embryos. This paper provides the first direct evidence that Tß4 plays a critical role in early embryonic vessel development and identifies a novel Hand-1-Tß4 pathway.
“These findings are important in that they establish the molecular mechanism by which Tß4 stimulates vascular growth of the embryo and opens up the possibility of utilizing Tß4 to potentially correct serious heart defects in utero,” stated Allan Goldstein, Ph.D., Professor of Biochemistry and Molecular Biology at The George Washington University School of Medicine and Founder and Chief Scientific Advisor of RegeneRx.
“We believe this research further supports development of RGN-352, an injectable formulation of Tß4, in acute myocardial infarction,” said J.J. Finkelstein, Chief Executive Officer of RegeneRx. “We plan to begin a Phase 2 study in AMI later this year.”
About Tß4
The Night Stalker
14 years ago
i went ahead and loaded up RGN today, i like the news the other day
Researchers Report in Neuroscience that TB4 Improves Neurological Function after Stroke
Date : 07/19/2010 @ 12:30PM
Source : Business Wire
Stock : RegeneRx Biopharmaceuticals, Inc. (RGN)
Quote : 0.284 0.012 (4.41%) @ 11:05AM
Researchers Report in Neuroscience that TB4 Improves Neurological Function after Stroke
Regenerx Biopharm In (AMEX:RGN)
Historical Stock Chart
1 Month : June 2010 to July 2010
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the Company” or “RegeneRx”) today announced a research team from the Henry Ford Hospital in Detroit, MI, reported that Thymosin beta 4 (Tß4), administered to rats after embolic stroke, improved neurological functional outcome compared to control animals.
The research was conducted by Dr. Daniel Morris and his colleagues at the Department of Emergency Medicine, Henry Ford Health System, Detroit, MI, and published in Neuroscience, 2010 Aug 25 169(2) 674-682, http://www.ncbi.nlm.nih.gov/pubmed/20627173. The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and the Henry Ford Health System.
Improvement in neurological function was measured at various time intervals over a seven week period and was statistically significant. A statistically significant increase in remyelination of axons and vessel density in the ischemic boundary was also observed between rats receiving Tß4 vs. controls, likely due to an increased mobilization of oligodendrocyte progenitor cells (brain stem cells that differentiate into cells that protect nerve fibers). mRNA levels for the epidermal growth factor receptor were determined in both normal and stroke rats treated with Tß4 and were approximately 50% higher in the stroke-treated rats. This receptor has previously been shown to be a key regulator of progenitor cell expansion and tissue regeneration in response to brain injury and further confirms the role of Tß4 in stem cell-mediated tissue repair.
“Some of these data were previously reported at an International Stroke Conference in March; however, the data published today include more specific information on functional remodeling and potential mechanisms of action related to recruitment and differentiation of oligodendrocyte progenitor cells. These data are compelling and elaborate previously reported data in EAE mice (experimental models for multiple sclerosis) and in traumatic brain injury in rats showing that Tß4 can effect regeneration of neuronal cells after injury. In this experiment, after an ischemic stroke, neurological function in the rat models was significantly improved, apparently by remyelination of neurological axons (nerve fibers that conduct electrical signals) induced by Tß4. The fact that Tß4 helps repair and regenerate tissue after a brain injury strongly correlates with other published data showing Tß4’s ability to regenerate neuronal and cardiac tissue after ischemic events,” stated Dr. Hynda Kleinman, former head of cell biology at the National Institute of Dental and Craniofacial Research, NIH, and a consultant to RegeneRx.
About Tß4
Tß4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-functional molecule that has been shown in pre-clinical studies to promote endothelial cell differentiation and migration in the heart and central nervous system, promote angiogenesis in dermal and cardiac tissues, increase keratinocyte migration and collagen deposition, and decrease inflammation by down-regulating inflammatory cytokines. RegeneRx has identified several molecular variations of Tß4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health and various academic researchers throughout the world have published numerous scientific articles in high impact journals indicating Tß4’s in vitro and in vivo efficacy in accelerating wound healing and tissue protection and regeneration under a variety of conditions. Abstracts of scientific papers related to Tß4’s mechanisms
surf1944
15 years ago
New T4 Eye Data to be Presented at ARVO Meeting
Press Release Source: RegeneRx Biopharmaceuticals, Inc. On Thursday April 8, 2010, 8:30 am EDT
ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.regenerx.com&esheet=6242329&lan=en_US&anchor=www.regenerx.com&index=1&md5=37474c0a84dd2105c087e77f59ba9832) announced today that Tß4, a synthetic version of a naturally occurring peptide that is the basis for the company’s product candidates, will be the subject of three poster presentations at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) to be held in Fort Lauderdale, Florida from May 2-6, 2010. The presentations will review results of research performed using Tß4 in the field of ophthalmology and will describe potential uses of Tß4, including for the first time, as a drug embedded in a bandage contact lens.
In the first presentation, “Developing a Bandage Contact Lens Delivery System for Controlled Release of Thymosin Beta 4 to the Corneal Epithelium,” Dr. Gabriel Sosne and his research team at Wayne State University School of Medicine in Detroit, Michigan will describe research performed to evaluate the potential for extended release of Tß4 for more than 100 hours. The researchers concluded that a bandage contact lens delivery system would be a novel, feasible and potentially useful way to promote direct application and extended release of Tß4 to the surface of the eye. Dr. Sosne is Associate Professor of Ophthalmology at Wayne State University School of Medicine, Department of Ophthalmology and Anatomy/Cell Biology in Detroit, Michigan. He is also a member of RegeneRx's scientific advisory board.
The second presentation, “Antioxidative Effect of Thymosin Beta 4 for Porcine Trabecular Meshwork,” will discuss results of research that was designed to evaluate the antioxidative effect of administering Tß4 to trabecular meshwork cells in a pig model. These cells make up tissue inside the anterior (front) part of the eye that is responsible for draining most of the fluid from the eye. The degree of fluid drainage and oxidative stress may be associated with increased intraocular pressure and glaucoma, which can injure the optic nerve. The researchers in this study determined that extracellular Tß4 has an antioxidative effect for hydrogen peroxide in the porcine trabecular meshwork cells. These findings may be relevant to reducing oxidative stress in these cells, which could potentially reduce the damage to the eye from glaucoma. The research was conducted at the departments of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine in Kyoto, Japan and Kumamoto University Graduate School of Medicine in Kumamoto, Japan.
A third presentation, “A Randomized, Double-Mask, Placebo-Controlled, Dose-Response, Phase 2 Study of the Safety and Efficacy of Thymosin beta 4 in the Treatment of Diabetic Patients’ Corneal Wounds Resulting from Epithelial Debridement During Vitrectomy,” will report on the clinical results from the company’s Phase 2 clinical trial of its product candidate RGN-259 in patients with corneal wounds. The particular patients for whom results will be reviewed were those patients who received either the lowest dose of Tß4 or placebo in the trial. The study was closed by RegeneRx after enrollment of the low-dose cohort due to slow patient accrual, in addition to emerging proof-of-concept data generated in compassionate-use clinical trials in patients with non-healing eye ulcers. As previously reported, the research team observed no serious adverse events following administration of RGN-259 and no statistical differences in the time to wound healing when comparing Tß4 to placebo. The researchers did note that there appeared to be increased thickening of the corneal epithelium and reduced inflammation (cell and flare) seen in Tß4-treated patients. These observations would be indicative of corneal re-epithelialization and wound healing and are consistent with known cell migratory and anti-inflammatory properties of Tß4. The principal investigator of the study was Dr. Benni H. Jeng, Chief, Department of Ophthalmology at the San Francisco General Hospital and Associate Professor and Co-Director, Cornea Service, University of California San Francisco Department of Ophthalmology and Francis I. Proctor Foundation.
“Taken together, the rapidly progressing research advancements in the eye with Tß4 are bringing the goal of making Tß4 a novel therapy for a number of ocular disorders closer to reality,” commented Dr. Sosne.
surf1944
15 years ago
9:00AM Regenerex Biopharam announces researchers report novel biological properties of fragments of Thymosin Beta 4 (RGN) 0.60 : Co announced that a university research team has published an article ahead of print in FASEB Journal, a high-impact scientific journal, describing novel biological properties of several Thymosin beta 4 (Tb4) peptide fragments. The researchers summarize related published studies and report on their work showing that Tb4 and these smaller peptides were able to block inflammation, reduce fibrosis, promote cell survival and block apoptosis, stimulate stem/progenitor cell differentiation, induce angiogenesis, and promote cell migration. Other activities include the induction of various genes encoded for important proteins involved in cell development (such as laminin-5, MMPs, TGF beta, zyxin, terminal deoxynucleotidyl transferase, and angiogenesis-related proteins) and activate signaling pathways that influence cell and tissue survival (such as ILK/PINCH/Akt).
pj McMulligan
15 years ago
September 29, 2009 - 11:42 AM EDT
RegeneRx's Tβ4 Significantly Improves Functional Recovery in Multiple Sclerosis Animal Model
Sep. 29, 2009 (Business Wire) -- REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers at the Henry Ford Health System in Detroit, Michigan, demonstrated for the first time that Tβ4 treatment of EAE (experimental autoimmune encephalomyelitis – an animal model for multiple sclerosis) significantly improves neurological functional recovery. In addition to this neurological benefit, the researchers reported a significant reduction of inflammation and induction of oligodendrogenesis (maturation of central nervous system cells associated with the formation of the nerve sheath), the control of which are important therapeutic goals.
The study entitled, “Neurological Functional Recovery after Thymosin Beta 4 Treatment in Mice with Experimental Auto Encephalomyelitis,” was published online ahead of print in Neuroscience, 2009 September 24. The publication highlights the statistically significant effects of Tβ4 treatment in EAE mice, including improvement of neurological functional recovery, reduction of inflammatory infiltrates in the brain, and increase of oligodendrocyte progenitor cells (a type of stem cell) and mature oligodendrocytes in the brain.
The research team was led by Jing Zhang, MD, PhD; Zheng Gang Zhang, MD, PhD; Dan Morris, MD; Yi Li, MD; Cynthia Roberts, Stanton B. Elias, MD, and Michael Chopp, PhD of the Departments of Neurology and Emergency Medicine at the Henry Ford Health System in Detroit, Michigan and the Department of Physics at Oakland University in Rochester, Michigan.
Multiple Sclerosis (MS)
There is no cure for MS. While considerable progress has been made in the recent years with the development of anti-inflammatory and immunomodulatory therapies, there are currently no effective repair therapies routinely used in multiple sclerosis patients. Clinical trials have clearly demonstrated that an anti-inflammation treatment approach alone is insufficient in preventing or ameliorating permanent and accumulating MS deficits. Moreover, many medications have serious side effects and some carry significant risks. Oligodendrogenesis/remyelination is an important therapeutic goal and the subject of the research described in the journal article.
Tβ4 and RGN-352
Tβ4 peptide is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of Tβ4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions in the U.S., have published scientific articles indicating Tβ4’s in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
RGN-352 is an injectable formulation of Tβ4 that has just completed Phase I clinical trials and has been shown to be safe and well-tolerated. The product candidate has been developed to address medical indications where systemic administration is warranted. RegeneRx is currently planning a Phase II clinical trial to evaluate RGN-352 in post-acute myocardial infarction (heart attack) patients, although other indications such as stroke, ischemic renal disease, and certain ulcerative and autoimmune conditions have been identified as potential targets.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. RegeneRx is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides.
Forward-Looking Statements
This press release contains certain forward-looking statements that 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. Examples of such forward-looking statements include statements concerning any future development efforts for RGN-352 as a treatment for stroke, multiple sclerosis, or other neurological indications, the results of future trials involving Tβ4, and the therapeutic potential of Tβ4 for neurological indications, or its use in other pharmaceutical or consumer products. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that RegeneRx’s product candidates may not demonstrate safety and/or efficacy in its ongoing or future clinical trials and other development efforts, including its trials and/or other development efforts related to RGN-137, RGN-259, RGN-352 and RGN-457, the risk that RegeneRx or its collaborators will not obtain approval to market RegeneRx’s product candidates in the U.S. or abroad, the risks associated with RegeneRx’s need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to RegeneRx’s product candidates, the risks associated with protecting RegeneRx’s intellectual property, or that RegeneRx will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in RegeneRx’s annual report on Form 10-K for the year ended December 31, 2008 and quarterly report on Form 10-Q for the period ended March 31, 2009, and other filings RegeneRx makes with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. RegeneRx undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Business Wire (September 29, 2009 - 11:42 AM EDT)
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