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Nuvilex, Inc. ι Diabetes Studies Could Eliminate Need for Daily Insulin Requirements

Nuvilex, Inc. ι Diabetes Studies Could Eliminate Need for Daily Insulin Requirements

Written by ι Stock Market Media Staff — March 18, 2013

When investors look into biotechnology and pharmaceutical companies as an investment opportunity, three areas of research stand out as the most favorable for future returns.  The big three are cancer, heart disease and diabetes research that can eventually lead to corresponding clinical trials.  Well, Nuvilex, Inc. (OTCQB: NVLX) is currently involved in 2 of the 3 – cancer and diabetes.

While Nuvilex prepares for a large-scale, late-phase clinical trial studying its treatment for patients with advanced, inoperable pancreatic cancer, the company is also using the same basic technology to study diabetes.  That technology is a unique and proprietary living cell encapsulation process, and the good news for those with diabetes is the basic technology has delivered astounding results in the company’s pancreatic cancer trials.

Newly Diagnosed Diabetes Numbers are Out of Control

By 2020, the market for diabetes medicines is projected to reach $65 billion worldwide.  According to the International Diabetes Federation, 371 million people around the world have been diagnosed with diabetes and another 187 million remain undiagnosed – leaving many millions susceptible to the debilitating, and even deadly, complications associated with this disease.

If left untreated, complications from diabetes can include; heart disease, vision loss, kidney disease, and nerve damage.  Diabetes 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.

It’s Time to Leave Behind the Injections and Pumps

Researchers are putting their focus squarely on those islet cells as they are the key to what can only be described as miracle science at Nuvilex.  The company is doing some amazing things with its living cell encapsulation technology that could make life much simpler for those who suffer from diabetes.

Many scientists, researchers, universities and biotech firms are diligently working to reduce a diabetic patient’s reliance upon injections and pumps to administer insulin into the body.  Here is where the aforementioned islet cells come into play – one such solution to the injections and pumps is through pancreatic islet cell transplantation.

Groundbreaking work in a high profile study called the “Edmonton Protocol” showed that pancreatic islet cell transplantations could hold the key to a game-changing diabetes therapy.  However, the problem in that study was that because the 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 islet cells.

Enter Nuvilex, Inc. and its living cell encapsulation technology that could potentially have the solution to this very problem.  One way to prevent attack by the diabetics’ immune systems on the transplanted islet cells could be to encapsulate the cells prior to transplantation.  In turn, this could make the use of immunosuppressive drugs unnecessary.  Nuvilex knows that they can accomplish this because, in the company’s mid-phase pancreatic cancer clinical trials, living cells encapsulated using their technology were protected from immune system damage for more than 2 years, without the use of immunosuppressive drugs, and were alive and well after all of that time.

Building an “Artificial Pancreas”

Nuvilex’s cell encapsulation or “Cell-in-a-Box” technology uses living cells, and the company takes a very specific type of cell to address a specific problem a patient suffers from – in this case diabetes.  Scientists then enclose the cells in unique “capsules” made mainly of cellulose, forming essentially “cotton bags” with live cells inside.  The capsules are about the size of the head of a pin. The capsules have “pores” in them that allow nutrients for the cells inside to enter and waste products and “beneficial” factors produced by the encapsulated cells to leave. Each bundle of encapsulated cells becomes much like a miniature cell factory with the ability to produce whatever is needed.

This basic cell encapsulation process can serve as a “platform” upon which treatments for many serious, debilitating, and even fatal diseases may be built.  Some of these diseases include different types of cancer, diabetes, diseases for which stem cell therapies are being developed, and diseases caused by viruses.

In Nuvilex’s 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 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.

Taking the Cost off of Taxpayer’s Hands 

Why is this incredible news for both diabetics and biotech investors?  The American Diabetes Association (ADA) recently announced that in 2012, diabetes cost the U.S. an estimated $245-billion.  That is an incredible 40% increase in just five years from the government’s 2007 statistics.  It’s simple – more and more people are being diagnosed with diabetes, and the government is responsible for about 62% of the costs.

In a discussion at a recent meeting on Capitol Hill concerning the alarming increase in the numbers of newly diagnosed diabetics, Robert E. Ratner, MD, the ADA’s Chief Scientific and Medical Officer said, “We have an incredible epidemic of diabetes that is driving health care expenditures excessively.  Unless we do something to stop diabetes, the economic cost will continue to rise.”  Congress was most assuredly talking about diabetes when it tasked the FDA with expediting new drugs to commercialization that meet areas of great unmet medical need.

Nuvilex’s work is certainly a great start to a potentially miraculous therapy for diabetics. With the numbers of diabetics quickly on the rise in the U.S. and throughout the world, the company’s work is great news for diabetics and investors alike – and don’t be surprised if the ADA and Congress don’t have their fingers crossed in hopes of the company’s success as well.

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