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Keep an eye on this one over the next few days to few months....below is some company info. I've been watching this one for 3 years. Got in early and stuck to it due to the product they are developing. Web site is http://www.regenerx.com. Should be solid news in the next 1-3 months based on the clinical trials they are working on. Check out November a year ago when news came out. Went from under 2.00 to over 8.00 in one day, before settling in around 5.00
RegeneRx Biopharmaceuticals, Inc.
RegeneRx (www.regenerx.com) is a biopharmaceutical company developing TB4 as a platform technology for the treatment of acute and chronic wounds and for a variety of human diseases involving tissue and organ repair. RegeneRx holds an exclusive, world-wide license from the National Institutes of Health pertaining to wound healing and tissue repair. It also holds over fifty world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, including the treatment and prevention of cardiac and neurological injuries, as well as issued patents related to the treatment of septic shock. RegeneRx recently initiated its first Phase II dermal wound healing clinical trials and has targeted cardiac and ophthalmic wound healing as part of its ongoing clinical development program in 2006.
Thymosin Beta 4
TB4 is a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, keratinocyte migration, collagen deposition, and down-regulates inflammation. A key mechanism of action is TB4's ability to regulate the cell-building protein, actin, a vital component of cell structure. Additionally, TB4 directly influences the production of laminin-5, a protein responsible for proper adhesion and migration of certain types of mammalian cells and an important component of the wound healing process. It has also recently been reported that TB4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and cardiac tissue. Researchers at the National Institutes of Health (NIH), and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that TB4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. A recent article appeared in the scientific journal, Nature, indicating that TB4 prevents and/or repairs cardiac damage in laboratory animals after a myocardial infarction (heart attack).
Posts: 17 | From: Indianapolis | Registered: Nov 2005
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Researchers Report Wound Healing Drug Significantly Reduces Cardiac Damage After Heart Attack Bethesda, MD, November 24, 2004 -- Researchers at the University of Texas Southwestern Medical Center report in the November 25th issue of Nature that Thymosin beta 4 (Tß4), a naturally occurring peptide being developed by RegeneRx Biopharmaceuticals, significantly reduced tissue damage, ventricular scarring and dilation, and markedly improved cardiac function when administered to laboratory animals immediately following induced myocardial infarction (heart attack). Heart attacks occur in over one million people annually in the United States with over thirteen million suffering from coronary artery disease, making it the single largest cause of death in the Western world.
Dr. Deepak Srivastava, the head of the research team and a professor specializing in pediatric cardiology, stated that, “While we do not know exactly how Tß4 is preventing or reducing damage to the heart, the evidence suggests that it may prevent apoptosis (natural cell death) resulting from a cardiac infarction. Tß4 may also be protecting the cardiac cells from dying by causing them to ‘hibernate' and withstand hypoxia (lack of oxygen) caused by a heart attack.”
“The effects appear similar to those reported in dermal and ocular wound healing studies using Tß4, especially at the cellular level, but it is remarkable that it has such an effect on a whole organ,” said Dr. Srivastava. He added that future experiments will be conducted in pigs, whose hearts most resemble humans.
According to Dr. Alan Wasserman, a noted cardiologist and Professor and Chairman of the Department of Medicine at The George Washington University School of Medicine in Washington, D.C., “This paper by Dr. Srivastava and colleagues is one of the most exciting works in the field of acute myocardial infarction I have seen. The ability to repair [cardiac] muscle after an acute infarction makes the use of Tß4, potentially, the most important discovery since the advent of thrombolytic therapy.”
Dr. Srivastava and his colleagues in the departments of pediatrics, molecular biology and cardiothoracic surgery administered Tß4 two ways: by direct injection into the heart muscle and by systemic injection. The effects from both methods were similar and results from both were significantly better than the control group.
The researchers also reported on the results of several in vitro experiments:
Tß4 administered to cardiac cells in vitro caused the cells to beat more rhythmically, more rapidly, more vigorously and twice as long vs. the control group. The addition of Tß4 onto a collagen-coated gel assay caused a large number of spontaneously beating, cardiac muscle cells to migrate in more numbers and further distances than control cells. Tß4 was expressed in specific regions of the developing heart that were undergoing active cell migration. “To my knowledge, there has never been a report of any agent able to affect cardiac cells in these ways. That we have been able to observe such results opens up a potential new approach for treating heart attack victims,” concluded Dr. Srivastava.
Posts: 17 | From: Indianapolis | Registered: Nov 2005
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RGN - Company is currently conducting 3 phase II trials. Results of at least one of those trials is supposed to be out the first quarter of 2006. Based on the studies, it does everything from grow hair to repair damaged heart tissue after a heart attack.
RegeneRx Cleared to Initiate Phase II Clinical Trial With Tß4 for Epidermolysis Bullosa BETHESDA, MD, February 28, 2005 - RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced it is clear to begin its third Phase II clinical trial to test its drug, Thymosin beta 4 (Tß4), for the treatment of patients with epidermolysis bullosa (EB). “We are pleased we are able to proceed according to our clinical development plan,” said David Crockford, Head of Clinical and Regulatory Affairs for RegeneRx. “EB represents a unique opportunity for RegeneRx, both from a scientific and business perspective. The ability of Tß4 to up-regulate the expression of laminin-5, among other things, may be very important for these patients since many are unable to effectively produce this adhesive protein. Further, as an orphan drug, we hope to be able to take advantage of a number of opportunities otherwise unavailable for large-market drugs, including funding of clinical trials by the FDA's Office of Orphan Products Development.”
The Phase II trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of Tß4 in a limited number of patients with dystrophic and junctional EB at a number of medical centers in the U.S. The drug will be topically administered to each patient every day over a period of several weeks.
Epidermolysis Bullosa EB is a rare genetic disease characterized by the presence of extremely fragile skin and recurrent blister formation, resulting from minor mechanical friction or trauma. Often these blisters can develop on the skin, eye, mouth, as well as other organs and tissues. There is estimated to be less than 50,000 patients with some form of EB in the U.S. The disorder occurs in every racial and ethnic group throughout the world and affects both sexes equally. Patients with the most severe form of EB either produce defective or little to no laminin-5, a protein that induces both adhesion and migration in a wide variety of cell types, including epithelial cells, fibroblasts, neurons and leukocytes. Laminin-5 plays a key role in maintaining the structural integrity of the skin.
Thymosin Beta 4 Tß4 is a naturally occurring peptide present in virtually all human cells. It represents a new class of wound healing drug and is different from other wound repair factors in that it promotes endothelial cell differentiation keratinocyte migration, and down-regulates a number of inflammatory cells. A key mechanism of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of cell structure. Additionally, it has recently been published that Tß4 directly influences the production of laminin-5, a protein necessary for proper adhesion of certain types of mammalian cells and an important component of the wound healing process. It has also recently been reported that Tß4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and, possibly, cardiac tissue. Researchers at the National Institutes of Health (NIH), and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that Tß4 is effective in accelerating dermal and corneal wounds in several animal models, under a variety of conditions. Recently, Tß4 was the subject of a publication in the scientific journal, Nature, indicating its ability to prevent and/or repair cardiac damage in laboratory animals after a myocardial infarction (heart attack).
Posts: 17 | From: Indianapolis | Registered: Nov 2005
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As RGN has developed TB4, the company is continuing to find applications within the healthcare industry. The company is beginning to get recognized within the industry.
RegeneRx's TB4 Receives Frost & Sullivan 2005 Technology Innovation Award BETHESDA, Md.--(BUSINESS WIRE)--Oct. 26, 2005--RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN) (www.regenerx.com) has been selected as the recipient of Frost & Sullivan's 2005 Technology Innovation Award for its novel wound repair technology platform. The platform, based upon a naturally-occurring molecule, thymosin beta 4 (TB4), is currently in Phase II clinical trials to evaluate its ability to accelerate dermal wound healing.
According to Frost & Sullivan research analyst A. N. Aditya. "The compound (TB4) has several more advantages than growth factors and can be produced at a low cost. The innovative technology represents a significant step forward in wound management, particularly for elderly patients, diabetics, immunosuppressed, and immobilized individuals."
The Award is presented to a company that has carried out new research and development resulting in an innovation that has or expects to bring significant contributions to industry in terms of adoption, change, and competition. The Award also recognizes the quality of the company's R&D program as well as the vision and risk-taking that has produced the results. After thorough evaluation of primary research, RegeneRx was selected because of the impact its innovations may have on the healthcare industry.
Posts: 17 | From: Indianapolis | Registered: Nov 2005
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RGN was up 18% this week. Trading was up also. History on this stock says there will be some type of news soon due to timing of Phase II trials ending and it being up 18%. Keep an eye on it over the next 30 days. If it continues to creep up, better get in before the news.
Posts: 17 | From: Indianapolis | Registered: Nov 2005
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