Orgenesis Inc. (OTCBB:ORGS) is developing a new technology for regeneration of functional insulin-producing cells, thus enabling normal glucose regulated insulin secretion, via cell therapy.
By using a therapeutic agent that efficiently converts a sub-population of liver cells into pancreatic islets phenotype and function, this approach allows the diabetic patient to be the donor of his own therapeutic tissue. The company believes that their major competitive advantage is in their proprietary cell transformation technology.
In this interview, Jacob BenArie MBA, B.Sc., President & CEO shares some detailed thoughts about his firm:
Question: Several cutting-edge treatments for diabetes have been proposed over the years. Why is now the right time to develop your approach, involving the use of a patient’s own cells to secrete insulin?
Jacob BenArie: Orgenesis’s approach involves transdifferentiation, which is the conversion of one adult cell type into an alternate type of adult cell with a distinct function. This approach bypasses the hazard of tumor formation upon implantation associated with two alternative approaches, involving the use of embryonic stem cells or induced pluripotent stem cells. Transdifferentiation is currently being analyzed for feasibility and safety in preclinical studies. Given the conceptual breakthrough represented by this process, it is not entirely surprising that it is not yet used in the clinic. By the year 2000, only a little more than a decade ago, common knowledge held that adult tissues in mammals are terminally differentiated. It takes comprehensive studies to change this dogma and demonstrate the clinical feasibility and safety of converting one type of cell into an alternate cell with distinct characteristics and function. The potential of this approach is so great that we are convinced it is well worth pursuing at this time.
Q: Can you talk a bit about the inherent advantages and challenges of autologous and allogeneic cell therapies?
Jacob BenArie: Autologous cell transplantation is a potential cell therapy approach that uses the patient’s own adult cells in order to treat the patient. Autologous transplantation, as opposed allogeneic transplantation, does not require suppression of the immune system in the patient. One of the significant advantages of autologous transplantation is that it could potentially be used to treat young patients.
Q: Are there certain diseases and health conditions that might benefit more from cell-based therapy than others?
Jacob BenArie: Yes. It is currently believed that the chief beneficiaries of cell-based therapy will include patients with degenerative diseases associated with the nervous system, the kidneys, the pancreas and the muscles. There is also a high probability that this form of therapy holds the potential to assist in wound healing.
Q: What prompted your strategy on the development of autologous insulin-producing cells, and why liver cells rather than pancreatic cells?
Jacob BenArie: Type I diabetes is an autoimmune disease, in which the insulin-producing cells in the pancreas are specifically attacked and destroyed (so they will be continuously destroyed by the autoimmune attack), so these cells cannot be used for therapy. On the other hand, liver is developmentally related to the pancreas, and both tissues are sensitive to glucose. In addition, liver has a substantial regenerative capacity and functional redundancy. (It is interesting to note that several members of the animal kingdom, for example eels and worms, do not have any separation between liver and pancreas; they have one organ that is called hepatopancreas.)
Q: What other tissues/medical conditions might be amenable to your technology?
Jacob BenArie: It is possible that skin fibroblasts, keratinocytes and mesenchymal cells could be theoretically converted to liver, pancreas, blood, nerve cells and so forth.
Q: If I understand correctly, you use a retrovirus vehicle to modify cell function and development. How do you answer concerns about potential risks due to retroviral insertion?
Jacob BenArie: No, we use adenoviruses with no insertions.
Q: What are your timelines through the clinical trials process?
Jacob BenArie: We are now in the process of evaluating the regulatory aspects of our preclinical data. Based on our regulatory consultancy opinion, we believe that we have solid and sufficient preclinical data; however, some more data might be requested by the regulatory agencies. We are also working on having a clinical research agreement with prominent clinical centers in Europe for our clinical studies.
Q: What are the biggest challenges facing your firm?
Jacob BenArie: One of the major challenges for a biotechnology company like Orgenesis is to find the right partners and to initiate clinical trials. This requires fundraising, which is not so easy for a company in our stage. However, considering the fact that we have already succeeded in converting human liver cells into autologous insulin-producing cells from more than 70 donors, and are engaged in attracting supportive investors, I believe that we’ll overcome this challenge.
Q: Tell us where your company stands financially.
Jacob BenArie: Orgenesis is a public company in the U.S., with ticker symbol ORGS, and is traded on the OTC Bulletin Board. Our investors strongly believe and support Orgenesis and our technology. The diabetes market is huge, with 200,000 new type 1 patients diagnosed each year. In my estimation, if and when we demonstrate in clinical studies that Orgenesis’s technology is viable, our company’s financial status will grow much stronger.
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