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Nuvilex, Inc. Will Enter Phase III Trials with Advantages Using Cell Encapsulation

Nuvilex, Inc. Will Enter Phase III Trials with Advantages Using Cell Encapsulation

Written by ι Stock Market Media Staff — July 9, 2013

When Nuvilex, Inc. (OTCQB: NVLX) enters its pivotal Phase III clinical trial using its cell encapsulation technology combined with the anti-cancer drug ifosfamide for the treatment of late stage, inoperable pancreatic cancer, the company will do so with a number of distinct advantages.  The encapsulated cells capable of converting ifosfamide into its “cancer-killing” form could very well prove to be the “magic bullet” that catapults Nuvilex’s treatment to the standard therapy for the disease.

Nuvilex’s advantages all start with the encapsulation process itself.  The company’s unique, proprietary, cell encapsulation technology forms a “platform” upon which treatments for many serious, debilitating, and even fatal diseases may be built; these diseases include, but are not limited to, different types of cancer and diabetes.

The “capsules,” in the cell encapsulation process, are made principally of cellulose and, once formed, act as “mini-factories” and can carry out specific functions like activating cancer drugs.  The porous nature of the capsules allow nutrients to enter and support the health of the encapsulated cells, and at the same time, the capsules are porous enough to permit activated drugs or other biological substances to leave and provide “beneficial factors” to their surrounding environment.  The cells cannot leave the capsules nor can other cells, like those of the immune system, enter the capsules. 

Because Nuvilex’s cell encapsulation process is a true platform technology, it has many possible uses versus other companies’ technologies that are often aimed at the treatment of a single type of cancer or a single disease.  Nuvilex also has advantages over other companies using cell encapsulation methods when it comes to using different types of cells.  Those companies may need to make major modifications to the encapsulation process with each cell type they use.  With Nuvilex’s technology, the company does not need to make such major modifications.

Another advantage is that the use of other types of cell encapsulation often results in inflammation and damage to tissues near the area where the capsules are implanted.  However, two independent Phase II clinical trials have shown that neither the cells encapsulated using Nuvilex’s technology nor the capsules themselves cause inflammation or damage after being implanted. 

A key concern with any implanted cells is attack by the host’s immune system.  Unlike other methods, the encapsulated cells in Nuvilex’s technology have proven they can’t be damaged by immune system responses.  It is because the capsules are “inert” due to the fact that they’re composed largely of cellulose.  As a result, cells, even those from “foreign” sources can be implanted in the body without need for the administration of drugs that decrease the body’s immune response.  This is important for potential therapies and will dramatically increase the technology’s versatility and value in the future.

In addition, by using Nuvilex’s technology, the encapsulated cells have proven they can remain alive and functioning for extended periods of time.  The company has said it is unaware of any other types of cell encapsulation that exhibit this quality to the extent of its technology. 

A great advantage with this technology was noted during preclinical studies and confirmed in the company’s two independent pancreatic cancer clinical trials.  It is that the capsules remain in the location they have been placed and don’t migrate.  This benefit helps to ensure delivery of the chemotherapy drug directly to the tumor.  Also, Nuvilex’s cell encapsulation technology has been developed using Good Manufacturing Practice standards (necessary for marketing approval by regulatory agencies such as the FDA). 

Once the company enters its pivotal Phase III trial, it should see additional data that will prove out all of these advantages.  Nuvilex’s capsules provide a healthy home for live cells, they allow those cells to remain alive for extended periods of time and allow them to remain cancer-drug-activating for as long as needed.  In the company’s two pancreatic cancer clinical trials, the capsules and the cells inside them were still present in patients without changes to either even after two years.

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