Written by ι Stock Market Media Group Staff — July 2, 2013
While Medtronic, Inc. (NYSE: MDT) and Johnson & Johnson (NYSE: JNJ) are developing devices that can essentially act as a type of “artificial pancreas,” Nuvilex, Inc.’s (OTCQB: NVLX) unique cell encapsulation technology has shown it too can develop a type of “artificial pancreas” in preclinical diabetes studies. Their approaches couldn’t be more different; however, all three companies are convinced that developing an artificial pancreas offers diabetics the best solution to independently monitor their blood sugar levels, and in turn, provide them with insulin when needed.
At the end of June, both Medtronic and Johnson & Johnson presented results from separate studies using their medical insulin pumps at the American Diabetes Association meeting in Chicago. The idea behind the “smart” pumps is to mimic a healthy pancreas by offering diabetics a type of artificial pancreas that can successfully monitor changes in blood sugar levels and then adjust the insulin being delivered to the diabetic in response to those changes.
As the two NYSE-traded companies turn to medical devices to act as their brand of artificial pancreas, the small, Silver Spring, Maryland-based biotech, Nuvilex, is turning to a much smaller and different option – transplanted living, insulin-producing cells enclosed in capsules about the size of the head of a pin, that form a bundle and act as a miniature cell factory that produces insulin upon demand inside the diabetics body.
According to the International Diabetes Federation, 371 million people around the world have been diagnosed with diabetes and another 187 million remain undiagnosed. As the number of diagnosed diabetics around the world grows, so too does the market for a solution. By 2020, the market for diabetes medicines and treatments is projected to reach $65 billion worldwide.
The disease is characterized by sustained high levels of sugar (glucose) in the blood. Glucose is a source of energy for all cells in the body, and the levels of glucose are regulated by insulin which is produced by islet cells within the pancreas. However, when blood glucose levels become elevated above normal and remain that way as a consequence of a “malfunctioning” pancreas or because of insulin resistance within the body, diabetes can result. In turn, very serious and even deadly consequences of the disease can become manifested in diabetic individuals.
Companies like Johnson & Johnson, Nuvilex and Medtronic are focused on regulation of the levels of blood glucose, and at the same time, developing a means to make the process work automatically inside the diabetic’s body and eliminating the need for countless finger sticks to test blood sugar levels and daily insulin injections to normalize them.
The aforementioned insulin-producing cells may be the key for Nuvilex to successfully reduce a diabetic patient’s reliance upon injections or pumps to administer insulin into the body and could well lead to a groundbreaking diabetes therapy. In preclinical studies, Nuvilex’s cell encapsulation process passed the test in what was seen as the major hurdle to successfully using transplanted cells from a donor source other than the patient themselves. In past studies, researchers found that when insulin-producing cells were derived from “foreign” donors, the patients would require heavy doses of expensive and potent immunosuppressive drugs for the rest of their lives to stop their immune systems from attacking and destroying the transplanted cells.
Nuilex’s unique live cell encapsulation technology has proven to this point, that it could be the solution to this hurdle. By encapsulating living cells using Nuvilex’s proprietary process, the company has shown in two independent, mid-phase pancreatic cancer clinical trials, that the encapsulated living cells were protected from immune system damage for more than 2 years, without the use of immunosuppressive drugs, and the cells were alive and well after all of that time.
The company further validated that good news with a 6-month animal study in diabetes where pancreatic islet cells from pigs were encapsulated using the company’s process and the capsules containing the islet cells were then implanted into live, diabetic rats. Within only a few days, the blood sugar levels of the rats became normal and stayed at normal levels for the duration of the study.
When the capsules were removed from the rats at the end of the study, the islet cells inside the capsules were still alive and functioning. Pigs were chosen as the source for the pancreatic islet cells because biologically they are the closest to humans. Because pancreatic islet cells from pigs (“foreign” donors) could be implanted in rats without the cells being rejected, this proves the islet cells inside Nuvilex’s capsules were protected from attack by the rats’ immune systems.
Armed with data from both the results of the pancreatic cancer clinical trials and the animal studies, the company feels it is in a strong position to essentially develop a type of “artificial pancreas” that controls blood sugar levels and eliminates the need for insulin treatment, all without the need for potent immunosuppressive drugs. Now, plans are now being made, in conjunction with a national diabetes foundation, to repeat these studies on a larger scale, and if successful, the expanded animal studies could lead to clinical trials in humans.