Written by ι Stock Market Media Staff — March 21, 2013
Nuvilex, Inc. (OTCQB: NVLX) has close to $30-million invested in its “Cell-in-a-Box” technology, and as the company gets closer to the start of its Phase III pancreatic cancer trial, the trial may be coming at just the right time!
Over the past month, we have laid out a series of articles that outline how the living cell encapsulation or “Cell-in-a-Box” technology at Nuvilex can dramatically change the treatments we use for many serious, debilitating, and even fatal diseases.
From the company’s clinical trials with patients suffering from advanced, inoperable, pancreatic cancer to its work in diabetes studies to create a type of “artificial pancreas” in order to eliminate the need for daily insulin requirements, to its potential to revive the excitement surrounding the use of stem cells and even to its move into the medical marijuana space which will initially focus on pancreatic cancer and cancers of the brain, Nuvilex has invested a lot of capital and time into its technology. This is time and money that has a value and price tag to a larger biotechnology or pharmaceutical company.
Big Pharma Looking in 2013
The fact that the company has completed two independent cancer trials and is prepping for a late-stage trial, could quite possibly leave Nuvilex sitting at just the right place, at just the right time. Earlier this year at JPMorgan’s annual healthcare conference in San Francisco, Bloomberg stated in an article that the days of the big deals in the industry are back. More than 400 companies attended the conference to make their presentations, schedule one-on-one meetings and to get a sense of available and competing assets.
If Big Pharma is on the prowl for deals that can resupply their own pipelines as long-time patents continue to expire, they’re likely looking at companies bigger than Nuvilex, but that means that mid-level biotechs and pharmaceuticals are savvy enough to build their own pipelines with new treatments and technologies that they can continue to work on, and in-turn, shop this improved pipeline to the big boys.
Let’s do the math. about $25-million has been invested into Nuvilex’s “Cell-in-a-Box” technology through two independent Phase II clinical trials and research. Nuvilex has invested about another $2-million to further the development of the technology beyond the clinical trials. And, now the company is making preparations for a large-scale Phase III clinical trial. The results produced from the technology have been nothing short of amazing through both its pancreatic cancer trials and in its performance during the company’s diabetes studies.
There is More Than One Way to Move a Mountain
This is almost $30-million dollars and plenty of great data that a larger biotech doesn’t have to risk. We say risk because a number of larger companies are finding that they’re sinking large amounts of cash into R&D to expand their pipelines and develop their own drugs only to have a clinical trial halted because of poor results. AstraZeneca Plc (NYSE: AZN) recently had two of its trials halted. One trial was for an ovarian cancer drug which was halted late into its development because it lacked a clear survival benefit, and the other was a depression drug that was halted due to weak results. Add Bristol-Myers Squibb (NYSE: BMY) Merck & Co., Inc. (NYSE: MRK) and Genentech to that list of companies that invested heavily into developing drugs only to have the study halted or shot down by the FDA.
The obvious question is why invest the money and time into trials that may end up a bust, when the larger companies can sit back and let the smaller biotechs do the heavy lifting, spend the money and prove the science works. If the science proves out, Big Pharma can swoop in and buy-out the smaller company removing a lot of the risks and time. It’s been happening this way for a long time now, and a lot of the companies that filled their pipelines with billion dollar drugs are seeing their patents run out on those drugs which allows for generic versions of the drug to come in and put a significant dent into that billion dollar market.
Plenty of Cash to Reload the Pipeline
Companies like Pfizer, Inc. (NYSE: PFE), Merck, and AstraZeneca have all had patents run out on drugs that made their shareholders very happy. These companies stock piled a lot of cash on the success of drugs like Lipitor, Singulair, and Seroquel, and restocking the pipeline with a new candidate drug, technology or therapy is all in a day’s work for these giants.
This leads us back to Nuvilex and its living cell encapsulation technology. Why is this technology a prime candidate for a buy-out? Well, the company has proven that this singular proprietary therapy can be applied to cancer, diabetes, stem cells just to name a few. It has a wide reach, and it would allow a larger company to explore its many uses – essentially allowing a larger company to expand its pipeline greatly with one technology.
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. 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 few highlights of Nuvilex’s Cell-in-a-Box technology include:
Pancreatic Cancer Trials Highlights
Twenty-seven (27) patients were included in the trials and a substantial response was seen in that the use of the living cell encapsulation-ifosfamide 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.
Diabetes Studies Highlights
So far 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, 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.
Stem Cell Highlights
→ Encapsulation of stem cells with the Cell-in-a-Box technology protects the cells from attack by the body’s immune system — the “pores” of the capsules are too small for immune system cells to get inside and destroy the cells within the capsules and are too small to allow the encapsulated cells to leave the capsules.
→ Due to the size of Cell-in-a-Box capsules, many cells can easily be fixed in one location. Capsules can be infused, injected or implanted into almost any tissue, organ or location in the body.
→ The Cell-in-a-Box capsule material is biologically inert, meaning that it doesn’t cause any immune reaction or inflammation at the site of capsule implantation, in the tissues that are near the capsules.
→ Once the cells have done their job, the Cell-in-a-Box capsules can be removed, if necessary… depending on implantation location.
→ By being safely enclosed in the Cell-in-a-Box capsules, the cells cannot “migrate” to distant locations within the body and form abnormal growths in those places.
The belief that Nuvilex’s cell encapsulation process protects the cells inside the capsules from migrating to distant sites within the body and from immune system attacks comes from the company’s two independent trials in advanced pancreatic cancer. Here, not only did encapsulated cells remain where they were implanted, but also, they were not attacked by the patient’s immune systems; thus, surviving and functioning for more than 2 years inside the body without stimulating immune responses towards them.
These are highlights from just three areas that the company has invested in to prove that the technology could truly change the face of healthcare. Immediately a buy-out would strengthen the buyer’s pipeline with a technology that can be used in so many areas. As the company prepares for its Phase III pancreatic cancer clinical trial, we can think of no better time for a larger company to swoop in and put their name on this potential game-changing development in healthcare.
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