Written by ι Stock Market Media — April 8, 2013
When Nuvilex, Inc. (OTCQB: NVLX) started its diabetes studies, it was likely well known then that while its late-stage pancreatic cancer trials are front and center, it is the company’s work in diabetes that could put it on the map and really turn some heads. The small Silver Spring, Maryland, biotechnology company is already getting attention for its cell encapsulation technology’s performance in its preclinical diabetes studies, and diabetics around the world surely have their fingers crossed that Nuvilex can continue to see such dramatic results.
At the end of 2012, statistics showed that 22.3 million Americans, or seven percent of the U.S. population, have diabetes. Last November, The International Diabetes Federation estimated that 366 million people were diagnosed with diabetes in 2011, and about another 180 million more are estimated as undiagnosed. That number is expected to climb to 552 million by 2030 if “urgent action” isn’t taken – that’s 1 in every 10 people on the planet! Worse yet, those numbers are estimated to grow to 1 in every 3 people by 2050 at its current pace.
These numbers are mind-boggling and leaven an indelible impression of just how widespread the disease is. Most of us likely know someone who lives with diabetes, and that person very well could be you. With the dramatic rise in diagnosed cases of diabetes, more and more children are being added to the painful statistics.
Diabetes Hits too Close to Home
This disease is everywhere and families from the east coast to the west coast and everywhere in between are affected. Whether it’s 11-year old Devin Dunn in Fredericksburg, Virginia, or 20-year old Nick Cozzi in Joliet, Illinois, or even 10-year old Austin Wikstrand in Kennewick, Washington, these young diabetics are part of a disturbing trend – families that must learn a whole new way of life to live with the disease. All three suffer from Type-1 diabetes, and have had to make many adjustments in their lives just to survive.
About 5 to 10% of all diabetics suffer from type-1 diabetes, formerly called juvenile onset diabetes because it mainly occurs in those who are 20 years of age or younger. With type-1 diabetes, the pancreas, having been damaged by autoantibodies, is incapable of producing insulin and as a consequence, these individuals require insulin daily that’s delivered either by injection or by an insulin “pump.” This is just the start of what families must endure.
Nuvilex certainly recognizes the trend, and its Chief Operating Officer Dr. Gerry Crabtree said the company is focused on using its technology to improve the lives of those suffering from many diseases and diabetes is a key focus. “At Nuvilex, we have an opportunity to use our unique cell encapsulation technology to try to help the millions of people worldwide who need daily insulin administration; these numbers are increasing by the day. This is particularly important for young people with type-1 diabetes who must currently carry this burden for the rest of their lives, but also for those with type-2 diabetes, like me I might add, who cannot now, or will not in the future, be able to avoid the need for daily insulin. We intend to grasp this opportunity and are dedicated to developing a treatment for diabetes with the greatest enthusiasm.”
This Disease Requires a Great Deal of Attention
This is good news for everyone who suffers from diabetes and the families that live the disease right alongside them. In the case of young Devin Dunn, his mother Dru-Ann Sgarlato says it’s the only life he’s known as Devin was first diagnosed when he was just four years old, and now seven years later, he’s lived with the disease longer than he’s lived without it. “There is a clear line of demarcation between before diagnosis and after diagnosis. It is as abrupt, painful, and shocking to your system as running into a concrete wall at 100 miles an hour. In an instant, the life of your child, your family, and your world as you know it, is forever changed.” She paints a picture that all too many parents are experiencing these days.
Nick Cozzi was a 17-year old high school junior when he first learned he had diabetes after suddenly collapsing in gym class back in 2010. “I could barely see or hear, and I felt numb all over. I got home and my mom took me to a local clinic where I learned my blood-glucose level was at 526. Because the normal blood-glucose level is 80, they immediately called St. Joe’s Hospital and quickly got me into a room. That’s when the doctor told us. I was the first in my family on both sides to be diagnosed with diabetes, and I have diabetes because of something as simple as a cold. When my immune system fought back, it also attacked my pancreas.”
With his senior year of high school still ahead of him, he had a new set of obstacles to overcome and a routine that he expects will follow him for the rest of his life. That routine for Nick is as meticulous as it is for everyone diagnosed with diabetes. It includes a great deal of monitoring glucose levels, watching what you eat, and carrying around equipment and snacks that most never even know about.
“Right as I wake up I have to check, and then it’s pretty normal until breakfast where I have to check my levels again. I check again at lunch, then again for a snack in the afternoon, at dinner and then before I go to bed at night. Depending on my numbers and what I am eating, that decides how much insulin I have to give myself. I always have a fear of going low in a situation where I couldn’t immediately treat it.”
Dru-Ann says she’s no stranger to the routine that every diabetic lives through daily. “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.”
Devin and Nick keep their meters with them just like the rest of us carry around our phones or our wallets, and Nick says he always has snacks on hand. “Just in case anything was to happen or if I ever feel funny, I always carry glucose with me whether it is granola bars, or sugar sticks. I am always in fear I will go low.”
Dru-Ann added, “He can’t just run out the door to play, ride his bike, walk the dog, or go sledding. He has to take his blood glucose kit with him. He can’t run in and grab whatever he wants to eat when he wants to eat it. It requires thinking about his food and planning for the carbs. It means wearing an insulin pump 24 hours a day.”
Unlike Devin and Nick, 10-year old Austin Wikstrand no longer uses an insulin pump. The fifth grader, who found out two years ago that he had type-1 diabetes, has opted for insulin injections instead after using the pump for about seven months. But, that doesn’t change his daily regimen as he too must spend a large part of his day monitoring his levels.
The ideal level for a person’s blood sugar is between 80-120 mg/dL, depending on when it is measured in relation to eating, but for a diabetic, so many things can impact those numbers: too much exercise, too much or too little food, illness, stress, being tired, changes in the weather, hormones, growth spurts and the list goes on and on. Austin’s parents said just this week he had to increase the number of times he monitored his levels. “He checks when he wakes up, before every meal, any time he feels “different” and before bed, so usually about five times a day. But, like today, he tested around 11 times because it’s hot outside and his levels go low when he plays hard in the sun. And, he goes high when it’s cold.”
Cell Encapsulation Technology Could Hold the Key to Change
In Nuvilex’s preclinical animal studies, the company has essentially been able to develop a type of “artificial pancreas” that controls blood sugar levels and eliminates the need for insulin treatment. In a 6-month study, pancreatic islet cells (produce insulin) from pigs were encapsulated using the company’s technology 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, and 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 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.
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.
Dr. Crabtree says of these results, “If these results can be translated to humans, millions of children with type-1 diabetes and older people whose type-2 diabetes can no longer be controlled by anti-diabetes drugs can live more ‘normal’ lives.”
Until Then We Dream
Nick says he longs for a day when he can wake up and read in the headlines that a company like Nuvilex announces its technology is available to dramatically change the lives of those living with diabetes. “If I no longer had to deal with all of these extra hassles and fears, it would make going about my day much easier. The amount of stress, worrying and fear released would be incredible. It’s hard to imagine not having to check anymore or worrying about miscalculating the carbs in the food I eat or the amount of insulin. Not having to do this would just be absolutely amazing.”
Devin, on the other hand, certainly dreams of a cure with his mother, but when he was nine years old after five years of dealing with diabetes he answered the question a bit differently when he and his mother were lying around, tired and dreaming. Dru-Ann shared their conversation, “Oh, I wish there was a cure. Don’t you wish there was a cure? He looked at me very sincerely and said, ‘If there was a cure, I’d give it to another child because me and you are doing alright. We know how to handle it!’ In his mind, there was only one cure for one child.”
His mother said she admired his maturity, but Devin’s response may very well have been shaped by his own mother’s steady approach to what hasn’t been an easy road and likely won’t be any easier until a company like Nuvilex can, at the very least, eliminate a big part of Devin, Nick and Austin’s grueling, daily routine.
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