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Nuvilex, Inc. Could Become Significant Player in the Oncology Arena with Successful Phase III Trials

Nuvilex, Inc. Could Become Significant Player in the Oncology Arena with Successful Phase III Trials

Written by ι Stock Market Media Group Staff — May 22, 2013

Nuvilex, Inc. (OTCQB NVLX) is a diamond in the rough in the truest sense.  Currently shares of the Silver Spring, Maryland, biotechnology firm can be purchased for around 0.15/share allowing investors to build an incredible position in the company for what could be a blockbuster future.  Don’t expect these great prices to last forever though.  According to Nuvilex’s COO, Dr. Gerry Crabtree, the company expects to start its pivotal Phase III trials in early 2014, so expect to start seeing news being released by the company as each piece of the trial starts to fall into place.  Those who have any experience at all investing in biotech and pharmaceutical companies know the excitement generated as the news starts to unfold and the Phase III trials draw closer.

Many can probably remember the days when Dendreon Corp. (NASDAQ DNDN) lit up NASDAQ’s boards with its first product, PROVENGE® (sipuleucel-T), a cancer drug approved by the U.S. Food and Drug Administration (FDA) in April 2010.  By the end of the month, shares of Dendreon had reached almost $60.00/share which was a far cry from the $2.60 the company’s shares hovered at while investors accumulated a position just one year prior to approval.

No one is saying that Nuvilex is going to $60/share, but what could be said is the company is ideally priced for investors who are looking for that diamond in the rough, should the past be any indication of the future.   If Nuvilex’s Phase III trials in advanced, inoperable pancreatic cancer are successful, and we have every reason at this point to expect that they will be, then a host of potentials enter the picture for the future of the company. 

Stock Market Media Group, a research and content development investment relations firm, contends that the Phase III trials for Nuvilex will be much like high school algebra where you knew the answer, but you still had to show your work.  It is our opinion that Nuvilex’s cell encapsulation technology is a “game-changer” and we feel the Phase III trials will confirm what the technology has already confirmed in two independent Phase II trials in advanced, inoperable pancreatic cancer.  

In the data from those trials using encapsulated cells capable of converting the anticancer drug ifosfamide into its “cancer-killing” form, Median Survival Time and the One-Year Survival Rate were about doubled as compared to historical data for Eli Lilly’s (NYSE LLY) Gemzar – the current standard and the only drug approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer.  Now, it’s up to Nuvilex to “show its work” to the FDA and other regulatory agencies.

The list of potential accomplishments for Nuvilex is growing if the company does, in fact, have successful Phase III trials.  And, if even one or two of those potential outcomes we’ve outlined below is realized, it could prove to be a real “boon” for Nuvilex shareholders.  After thoroughly digging into the information, the research and consulting with professionals in the oncology arena to gain a better understanding of how biotech successes are met in the industry, we’ve compiled a list of seven potential outcomes for Nuvilex if the Phase III trials are successful.  Keep in mind the biotech community is looking on and these are researchers and science-based people, so they’ll be skeptical and Nuvilex will have to prove the science works.  The company is clearly up to the task.

1.  First and foremost is that the use of Nuvilex’s cell encapsulation as an adjunct to cancer chemotherapy will be validated.

2.  Given number 1 on the list, if the Phase III trials are successful, then cell encapsulation with the anticancer drug cyclophosphamide might also be tried (either by Nuvilex or by others) for the treatment of breast cancer, particularly as part of commonly-used combination chemotherapy treatments that now employ cyclophosphamide. 

Interestingly, cyclophosphamide is a “sister” drug to ifosfamide and can be converted into its cancer-killing form by the same cells as those used in Nuvilex’s mid-phase clinical trials in advanced, inoperable pancreatic cancer.

3.  It should become obvious to oncologists that cell encapsulation allows for the “optimization” of the cancer-killing effects of anticancer drugs that need to be activated (e.g. ifosfamide, cyclophosphamide) or converted (e.g. 5-fluorocytosine). 

At the same time, the overall toxicity profile(s) of the drug(s) may be minimized; this would result in improved quality of life for the patients undergoing therapy.

4.  The combination of cell encapsulation and ifosfamide could well replace Gemzar (gemcitabine) as the “single-drug treatment of choice” for advanced, inoperable pancreatic cancer.  If so, cell encapsulation/ifosfamide would be talked about in the oncology community the way that gemcitabine is today.

5.  Cell encapsulation/ifosfamide would be open to combination chemotherapy of advanced, inoperable pancreatic cancer with other drugs such as Tarceva (erlotinib) and Abraxane (Celgene’s nanoparticle formulation of albumin with Taxol [paclitaxel]).  

In other words, cell encapsulation/ifosfamide plus Tarceva could become the treatment of choice for the disease in the same way that the gemcitabine/Tarceva combination (approved by the FDA) is now.  Cell encapsulation/ifosfamide may also be an improvement upon Celgene’s gemcitabine plus Abraxane treatment (FDA approval expected to be sought by Celgene).

6.  Entities like “big pharma” could become very interested in the use of the cell encapsulation technology, particularly for oncology; this could result in licensing agreements that are lucrative for Nuvilex, Inc.

7.  And, last but not least, if the company’s Phase III clinical trials are successful; Nuvilex could become a significant “player” in the oncology arena.

If the trials are successful, after having “shown its work” on the grandest stage – a Phase III trial, Nuvilex will surely be the talk of the oncology community as the company will officially be “on the map” and a lot of doors could be opened to the treatment of other tumors using the company’s technology. 

Cell encapsulation isn’t new, but Nuvilex’s technology and approach certainly is, because the capsules are made largely of cellulose, a bio-inert material.  The company has shown that the capsules do not cause any kind of inflammatory or other “irritative” response in nearby tissues after implantation in the body, and that they are fully protective of the cells inside them while in the body.  In the company’s studies, the cells stay alive and functioning for long periods of time in the capsules inside the human body; as a matter of fact, they stayed alive for more than 2 years in the pancreatic cancer trials, and there was no immune system damage to the cells.

Successful Phase III trials would likely turn many heads, and it could very well draw many researchers out of the woodwork asking “What if…” and by this we mean, companies with dwindling pipelines may see Nuvilex’s cell encapsulation as a veritable playground of possibilities.  One thing is for sure – the company is getting closer and closer to releasing news that sets the entire Phase III trials into motion, and these are exciting times if you understand biotechs.  Nuvilex’s current share price makes it even more exciting as many will likely have a very impressive position in the company as it sets out on a journey bigger than the company itself – for now!