Written by ι Stock Market Media Staff — March 26, 2013
Nuvilex, Inc. (OTCQB: NVLX) is a small biotechnology company out of Silver Spring, Maryland, but its future might be anything but small. As the company diligently prepares for its Phase III pancreatic cancer trials, the almost $30-million the company has invested in its unique and proprietary living cell encapsulation or “Cell-in-a-Box” technology could be money well spent given the return in annual sales that cancer drugs bring in the marketplace.
Nuvilex has about $25-million invested in two independent Phase II clinical trials in patients with advanced, inoperable pancreatic cancer using the combination of the widely used anti-cancer drug, ifosfamide, together with encapsulated cells capable of converting the ifosfamide into its “cancer-killing” form and in pre-clinical studies of other applications for the technology. In addition, the company has put almost another $2-million into furthering the development of the “Cell-in-a-Box” technology itself.
This is a pretty hefty price tag for such a small biotech, but with the results the company has seen to date in its two clinical trials, the future looks very bright. In those trials, the results show that Nuvilex’s treatment outperforms the current standard, Eli Lilly’s (NYSE: LLY) Gemzar.
Why is this significant to Nuvilex? It’s all about the math and right now. Gemzar – the standard single drug for pancreatic cancer patients – equals about $1.4-billion annually to Eli Lilly. That’s billion with a B. Cancer drugs are big business, and those drugs are even bigger business when they work, and when they extend lives, and so far, Nuvilex’s cell encapsulation technology has shown it does work and it does extend lives.
Before we look at the results that are better than the current standard, let’s look at how the technology works and why, quite frankly, it’s better than adding another drug to a cancer patient’s daily routine.
Nuvilex’s cell encapsulation 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 pancreatic cancer. Virtually any type of cells whether they are drug-activating cells, drug-producing cells, stem cells, or even probiotic bacteria can be encapsulated with only very minor modifications to the company’s process. 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.
A glance at the significant results in those two independent Phase II clinical trials shows that with twenty-seven patients included, a substantial response was seen in the use of the living cell encapsulation-ifosfamide combination; in other words, the combination helped patients to a better outcome than that previously reported with standard single-drug (Gemzar) therapy.
Results from these trials included; median survival time and one-year survival rate were almost doubled as compared to historical data for Gemzar. The severity of ifosfamide’s side effects was reduced because only one-third of its usual dose was used. No damage to tissues surrounding capsules was seen. Cells within the capsules were protected from attack by the patients’ immune systems. Cells inside the capsules were alive and functioning – even after more than two years.
In the company’s Phase III trial, Nuvilex’s pancreatic cancer treatment will be compared “head to head” with Gemzar. Whereas only two cycles of ifosfamide were used in the Phase II trials, for the Phase III trial, more than two cycles will be given, as is often the case when ifosfamide is used in cancer treatment.
If the results obtained with Nuvilex’s treatment are statistically better than those obtained with Gemzar, the company’s treatment could replace Gemzar as the “gold standard” for the treatment of this devastating disease.
And, this is only the company’s treatment for advanced, inoperable pancreatic cancer which is as severe a disease as it gets – what about using this technology in the development of treatments for other types of cancer? After all, if the company can improve upon the industry’s standard single-agent drug for advanced pancreatic cancer which draws over a billion in annual sales, how much could it cut into the market of say – Bristol-Myers Squibb’s (NYSE: BMY) Taxol which is used for a variety of cancers? Taxol has netted Bristol-Myers Squibb well over $11-billion and it too was earning over a billion dollars annually before the generics were allowed to duplicate the drug. Or how about relative cancer “newbies” like Genentech/Roche’s Avastin – about $2.5 billion in sales annually. The list goes on.
Nuvilex’s “Cell-in-a-Box” technology could make its mark by improving on the industry standard in one type of cancer after the other, and when you start to think of the billions being made each year in those drugs, that certainly makes the technology well worth the investment to date.
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