Covalon Achieves Another Important Preclinical Milestone in its EPAS-1 Research Project for Treating Congestive Heart Failure and Tissue Regeneration
May 28, 2008
Mississauga, Ontario – May 28, 2008: Covalon Technologies Ltd. (TSX Venture: COV) is pleased to announce that it has successfully achieved another important preclinical milestone in its most significant research project, code-named EPAS-1.
The objective of the EPAS-1 research project is to identify a medical breakthrough for stimulating new blood vessel growth and tissue regeneration in tissues damaged by loss of, or restricted blood flow due to congestive heart failure, diabetes, chronic wounds, peripheral vascular disease and other conditions.
Dr. Frank DiCosmo, Covalon’s CEO and co-founder explained, “The EPAS-1 research project is expected to allow Covalon to produce “universal donor” mesenchymal stem cells that can be used by all individuals for use in myocardial preservation by therapeutic cell transplantation following loss of blood flow due to coronary vessel occlusion. The use of a “universal donor” will allow for simplification and standardization of procedures related to stem cell therapy including cardiovascular disease and generally in regenerative medicine. Covalon’s cell therapy program is designed to generate mesenchymal stem cells (EPAS1-cells) that express genes that control the production of growth factors at the site of cell transplantation that may be useful for new blood vessel formation, maturation and tissue regeneration.”
“The market opportunity for EPAS-1 is huge”, said William Jackson, Covalon’s Chief Business Officer and co-founder. “Cardiovascular disease is a world-wide problem. In industrialized countries, the prevalence of cardiovascular disease is related to an increasingly unhealthy lifestyle, with risk factors such as lack of exercise, a fatty diet, obesity and smoking. These risk factors are also linked to diabetes that is associated with an increased risk of developing heart disease – it has been estimated that there are approximately 20 million diabetics in the United States alone.”
In recently completed preclinical studies, swine stem cells derived from the marrow of a single donor animal with blood group “O” could be readily isolated, genetically manipulated with EPAS1, frozen and thawed for use. Various dosages of mesenchymal stem cells, greater than 90% viability, prior to injection, could be introduced into the myocardium of eight recipient swines 7 days post-myocardial infarction; surviving cells could be readily identified two weeks post-implantation. Mesenchymal stem cells altered with the EPAS1 gene showed significantly enhanced production and secretion in vitro of several important protein factors that are essential to new blood vessel growth (angiogenic) and further maturation. Direct introduction of genetically engineered EPAS1 cells by intra-cardiac injection into the hearts of swines showed no significant, adverse side-effects. In vivo, mesenchymal stem cells altered with the EPAS1 gene initiated an enhanced host-derived angiogenic response over that of non-EPAS1 modified mesenchymal stem cells. EPAS1 over-expression and the various proteins under control of the EPAS1 gene, enhances the cellular regenerative properties of mesenchymal stem cells by inducing secretion of certain protein factors that are essential to robust angiogenesis and functional maturation. EPAS1 is mainly expressed in vascular endothelial cells, that are essential to new blood vessel growth and appears to drive a superior angiogeneic response with enhanced stability of the resultant vessels. The overall significance is that mesenchymal stem cells can be readily isolated, grown to useful dosages and manipulated genetically to express EPAS1 for therapeutic application in damaged heart tissue. Covalon’s approach is intended to improve the function of damaged tissue, rather than merely address the symptoms of the disease. EPAS1 cell therapy is intended to enhance the beating of the damaged heart tissue with a cell therapy that delivers mesenchymal stem cells loaded with the EPAS1 gene that controls the production of many essential blood vessel growth factors. The system is expected to improve blood flow and oxygen delivery to the damaged heart by stimulating the growth of new blood vessels, by a process of therapeutic angiogenesis.
Porcine myocardial studies were performed off-site by an independent research organization under contract to Covalon, and mesenchymal stem cells preparation, gene enhancement and characterization were conducted by Dr. Jacques Galipeau, MD, FRCP(C), Associate Professor of Medicine and Oncology at the Sir Mortimer B. Davis Jewish General Hospital (McGill University).
The need for improved methods to repair and regenerate tissue has fueled the development of many innovative technologies in the wound care market. The convergence of pharmaceutical, medical device, and biotechnology companies have both altered and shaped the market in the hard-to-heal wound industry. Advanced-technology bio-engineered products that actively stimulate and/or integrate with wound milieu and tissues to promote faster wound healing are increasingly being sought after. Active wound care products show an added advantage over the traditional dressings in terms of healing rate by providing and promoting an environment conducive to rapid wound healing. These technologies will address unmet clinical needs of an aging population, as well as improve patient outcome in a wide range of medical fields.
Covalon develops interactive wound care products that are intended to actively support the healing of wounds and regeneration of tissues through processes that interact either directly or indirectly with the damaged area. The current products in distribution and the processes under development are far more advanced than traditional wound care treatments, and consist of collagen-based materials and platforms, as well as bioactive, molecular coatings for implantable medical devices. Interactive wound care products can serve as temporary coverage for a wound designed to stimulate improved tissue repair. The components of these products may include growth factors and enzyme inhibitors to cellular “allogenic” or universal donor mesenchymal stem cells, engineered to carry the EPAS1 gene and induce angiogenesis at the site of cellular deposition, or such cells can be adhered to and delivered via a collagen-based scaffold. The target markets for such products include chronic and acute wounds, burn wounds and regenerative medicine.
About Covalon:
Covalon Technologies Ltd. is a company with advanced medical platforms that has developed and patented advanced therapeutic biomaterials for wound care and surgical applications and anti-infection coatings. Polymer chemistry and surface coating technology have been combined to create a range of time-release drug delivery platforms that are applied to many medical devices to treat many critical conditions. A variety of applications for these technologies have been identified and specific products have been developed. The products offer features and benefits providing solutions to many of the problems caused by current devices and their material properties which are used by most medical device manufacturers and suppliers. The problems include infection, poor biocompatibility, and microbial attachment. The company has an active program devoted to developing a cell therapy technology. The company’s EPAS1 platform is intended to deliver precursor cells loaded with the EPAS1 gene that is expected to induce therapeutic angiogenesis and blood flow to ischemic tissues.
Additional information can be found at www.covalon.com or by contacting:
Frank DiCosmo, Ph.D.
President & CEO
- or -
Francis K. Lindayen, C.A.
CFO
Covalon Technologies Ltd.
T: (905) 568-8400
F: (905) 568-5200
www.covalon.com
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