Written by Ι Stock Market Media Group Staff — October 21, 2014
Nuvilex, Inc. (OTCQB: NVLX) has carefully mapped out its plan to develop a diabetes treatment using the Cell-in-a-Box® platform technology. It started in November 2013 when the company acquired the exclusive worldwide rights to use the cellulose-based live-cell encapsulation technology for the development of treatments for diabetes. This acquisition gave Nuvilex a proven delivery system with which it could firmly plant its flag in the race for a diabetes treatment.
Now, almost one year later, Nuvilex has quite possibly made a game-changing leap forward in that race by securing a line of “live cells” that could potentially be encapsulated in the Cell-in-a-Box technology.
Last week the company announced that it has secured the worldwide rights to use human insulin-producing cells (Melligen cells), developed by professor Ann Simpson and her colleagues at the University of Technology in Sydney, Australia (UTS), for the development of a treatment for insulin-dependent (Type 1 or juvenile-onset) diabetes.
In these two agreements, Nuvilex has the necessary ingredients, a delivery system and human insulin-producing cells, to develop a treatment that can compete commercially in the almost $500 billion global diabetes healthcare market. Currently there is a mad dash to develop such a treatment that can address what is becoming a real epidemic with close to 400 million people worldwide living with diabetes. According to the International Diabetes Federation, that number is expected to balloon to 552 million by 2030.
Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, which is a hormone that enables people to get energy from the foods they eat. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. Currently treating the disease requires a lifetime of daily injections of insulin to control blood glucose levels.
When Dru-Ann Sgarlato, the mother of a 12 year old Type 1 diabetic, read that Nuvilex had secured the worldwide rights to use these human insulin-producing cells, she said, “Amazing! It’s sometimes frustrating that they can do all of this but we still don’t have a cure. Hell, if my son Devin could have 2 years before having to inject these cells again it would be so worth it. I’d cry and fall to my knees.”
The 2 years that Sgarlato is referring to relates to one of many advantages Nuvilex’s delivery system has over the competition. Cell-in-a-Box is a cellulose-based encapsulation technology that has proven through two Phase I/II advanced pancreatic cancer clinical trials that it does not break down even after long periods of time (greater than 2 years) after being implanted inside the body.
Another key advantage that Cell-in-a-Box holds over competing cell encapsulation technologies, which is especially relevant to a diabetes treatment, is that the capsules do not elicit a response from the body’s immune system which would destroy the capsules and the insulin-producing cells inside them.
Dru-Ann Sgarlato of Fredericksburg, Virginia, is a typical parent of a diabetic child who spends every single day dealing with injections and pumps and constantly monitoring blood glucose levels to keep her son safe. “We check Devin’s blood sugar approximately 15 times a day and all through the night, every night. At year’s end, Devin’s fingers have been poked no less than 5,400 times.”
The Melligen cells will have to endure preclinical and clinical testing, but essentially they would replace the insulin-secreting beta cells that have been destroyed by the autoimmune process in Type 1 diabetics.
Professor Ann Simpson and her team developed the Melligen cells which were originally derived from a human liver cancer cell line. Before Nuvilex can use the cells in the development of its treatment, the company will first have to prove that they do not form tumors (tumorigenic) when implanted into animals. If studies successfully prove the Melligen cells are not tumorigenic, Nuvilex plans to have them encapsulated using the Cell-in-a-Box technology as part of its planned treatment for diabetes.
It is believed that animal testing of the encapsulated Melligen cells will prove that they are capable of producing insulin “on demand” in diabetic animals. As blood glucose levels rise in animals implanted with Melligen cells, these cells will produce increasing amounts of insulin in response. When blood glucose levels fall, less insulin will be produced by the Melligen cells.
Nuvilex’s decision to acquire the worldwide rights to use Cell-in-a-Box to develop a diabetes treatment was based, almost exclusively, on the results of a “proof-of-principle” study, much like the Melligen cells will endure, where islet cells (from pigs) that produce insulin were transplanted into diabetic rats. The rats had much higher than normal levels of glucose in their bloodstream and had a difficult time controlling their glucose levels, just as humans with diabetes do.
In those diabetic rats that received Cell-in-a-Box with the encapsulated islet cells, their blood glucose levels normalized and remained stable for the duration of a 6 month study, indicating the encapsulated cells produced insulin in response to their higher than normal blood glucose levels.
According to the company, the cellulose-based Cell-in-a-Box technology seems to have prevented the encapsulated cells inside from being attacked by the diabetic rats’ immune systems, even in the absence of immunosuppressive drugs.
So, in this “proof-of-principle” study, the encapsulated cells appear to have acted as a type of “artificial” or replacement pancreas. Now, the company hopes to duplicate that success, this time with human insulin-producing cells. Ultimately, Nuvilex’s plan is to encapsulate Melligen cells using the Cell-in-a-Box technology and then placing them into patients with Type 1 diabetes where, hopefully, they will serve long term as a form of “bio-artificial pancreas.”