Here is some good info taken from company literature available to all shareholders and potential shareholders/investors
The Company was formed in 1986 to develop diagnostic products and services. During the 1990’s, we developed, manufactured and marketed a line of specialty biological products targeting a niche market in diagnostic testing. FDA approval was not required and the Company was able to rapidly market products and establish revenues. The Company generated high margin sales that supported all operations including R&D. In 2000, the Company sold its diagnostic operations to AspenBio Pharma, Inc. (OTC Bulletin Board, APNB.OB)
Since 2000 the Company has commercialized products derived from its human cell technology and achieved landmark breakthroughs in human stem cell research. Our products are primarily sold through a distribution agreement with a third party. The Company is presently focused on expansion of this product line to include stem cell-derived endocrine cells of the human pancreas gland for use in research and drug discovery, which represent a larger market opportunity than the presently marketed products.
Products & Technology Platform
STEM CELL TECHNOLOGY: Products for Research, New Drug Development and Therapy of Degenerative Diseases. The Company’s current stem cell technology consists of methods for the generation of human adult stem cells. We have used these methods to generate numerous stem cell lines and also developed methods for differentiation into functional human pancreatic beta cells that synthesize and release insulin. Type I diabetes or juvenile onset diabetes results from loss of beta cells of the pancreas gland due to autoimmune reactions that destroy beta cells. This disease is usually treated by a combination of insulin injections, monitoring and control of blood glucose levels. However, insulin therapy is not a cure and diabetics are at high risk for developing cardiovascular disease, blindness, diminished wound
healing, kidney disease and numerous other complications that shorten life expectancy. It has been recently shown that beta islets may be derived from donated pancreas organs, processed and transplanted into Type I diabetics resulting in long-term insulin independence and reduction in other complications of diabetes through a procedure known as the Edmonton Protocol.
A key goal of our pancreatic stem cell research is to cure Type I diabetes through the generation of an infinite amount of fully functional human beta islets that are suitable for transplantation into diabetic patients. Since these implanted cells are identical to the beta cells destroyed in diabetes, the implants will restore full endocrine functionality and maintain glucose homeostasis. It follows that the numerous complications of diabetes such as heart disease will be eliminated by this new, state-of-the art cellular therapy. The Company’s current business development strategy includes the near-term commercialization of related products targeting other markets in research, drug development and animal therapeutics. Management believes that the advanced state of its technology and long-term commitment to cell line generation as most recently reflected in its breakthrough technique for the differentiation of intact human beta islets from stem cells places the Company at a significant competitive advantage in the commercialization of its stem cell technology.
The Company’s patent-pending technology for generation of adult stem cell lines has application to other organs besides the pancreas gland. Development of these new stem cell lines is expected to yield other products with application in the treatment of other diseases, especially degenerative disorders characterized by death or functional impairment of specific cells. These degenerative conditions include but are not limited to heart attack, congestive heart failure, muscular dystrophy, stroke, spinal cord injury, Alzheimer’s disease, Parkinson’s disease, age-related hearing loss and macular degeneration.
2. Research & Drug Development Products: We presently sell products to the medical research industry. These include various human cell lines of pituitary and pancreatic origin and a cell culture growth medium, called VitroPlus II, as well. Medical laboratories use cell lines for various experimental purposes including the testing and discovery of new drugs, which requires growth of cells by a process called cell culture. This is a specialized area of medical research involving skilled personnel, specialized equipment and optimized growth media. VitroPlus II is a proprietary formulation that has been optimized by the Company for growth of its human pancreatic stem cell lines. It may also have broader application in the growth and maintenance of other cell lines.
3. Current Status of Stem Cell Research: We have demonstrated self-renewal of our stem cell lines through several lines of independent evidence and shown that our stem cell lines utilize the same pathway as do other stem cell lines to drive self-renewal. We have also demonstrated multipotent differentiation capacity of our stem cell lines. Biological markers of both human alpha and beta cells that synthesize and release glucagon and insulin have been detected within islet cells differentiated from our stem cell lines. Glucose-stimulated insulin secretion has been demonstrated indicating differentiation into functional beta cells. The Company has recently developed a refined differentiation method that enables the commercial production of stem cell-derived beta islets from its stem cell lines. We are presently engaged in pilot production runs to support initial commercial distribution of this product. Product sales will not require FDA approval prior to marketing since their use will be limited to in-vitro research and manufacturing applications only. These products will be classified as Type I Medical Devices and will require listing with the FDA but will otherwise be exempt from FDA regulation.
Markets, Business Model & Competitive Advantages
Products for Research, Drug Development and Treatment of Animal Diabetes. While the market potential for a new human cell therapy of diabetes is enormous, the pathway to this market is long and costly. However, our plan also includes commercialization of derivative products targeting research, drug development/manufacturing and animal therapeutic markets prior to regulatory approval of a cell therapeutic product for treatment of human diabetes. A current target is the expansion of our present product line to include stem cell-derived human beta islets and related products. Human beta islet cells have substantial application to the development of new drugs both in safety and toxicology testing of all new drugs and also in the development of new drugs for treatment of diabetes. We intend to commercialize our stem cell-derived beta islets for such applications through sales of products, services and select non-exclusive licenses with those pharmaceutical firms engaged in such development, e.g., Merck, GlaxoSmithKline, Roche, Lilly, Takeda, etc. Another application of stem cell-derived beta islet cells is in the treatment of animal diabetes, which is also a significant health issue. Our initial target is cell therapy for diabetes in dogs and cats, but this may be expanded to include other species.
Cell Therapy of Human Diabetes. Diabetes is a serious worldwide public health problem, with 156 million people globally afflicted in 2000. The prevalence of diabetes is increasing at an alarming rate due especially to risk factors associated with life style. Most patients suffer from Type II diabetes (resistance to insulin) while about 10% suffer from Type I diabetes and require insulin therapy. In the USA and elsewhere, diabetes continues to place a substantial financial impact on healthcare. Diabetics incur healthcare costs approximately two and one half times higher than people without diabetes primarily because of cardiovascular complications such as heart disease or stroke. We plan to target Type I diabetes mellitus as the primary initial therapeutic indication.
The pathway to commercialization of a cell therapy product for use in diabetes treatment is estimated to require 5 to 10 years product development and cost $0.5 to $1 billion. Hence the Company’s strategy to develop this product depends on early establishment of key strategic alliances with suitable partners and focus on primary elements of a pre-clinical research program leading to an IND (Investigational New Drug) award from the FDA. Given achievement of our product development goals, a primary competitive advantage is that our product will be a cell therapy of Type I diabetes. The stem cell-derived beta cell implant is anticipated to maintain physiological regulation of blood glucose levels while avoiding immune rejection for the duration of implant functionality. Hence, this treatment will replace the function of beta cells that are lost in Type I diabetes while restoring full endocrine function of the pancreas gland eliminating the serious complications of diabetes including cardiovascular and kidney disease.