Written by ι Stock Market Media Group Staff — April 29. 2013
While many biotech and pharmaceutical companies are designing one drug after another to address specific problems, Nuvilex, Inc. (OTCQB: NVLX) is using its own living cell encapsulation as a “one size fits all” type solution. The company is off to a great start at getting its “Cell-in-a-Box” technology on the map with its work in late stage, inoperable pancreatic cancer.
Nuvilex is headquartered in Silver Spring, Maryland, and while it is a small international biotech, the company has been delivering big results, and now it’s preparing for an even bigger stage – Phase III clinical trials. When it comes to pancreatic cancer, you can bet Eli Lilly (NYSE: LLY) and Celgene Corp. (NASDAQ: CELG) are all too familiar with Nuvilex and its technology. Currently, Eli Lilly’s drug Gemzar is the only drug to date approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer and the drug is considered the “gold standard” by the market. Eli Lilly introduced gemcitabine (Gemzar) back in 1996, and since that time, it has netted the drug’s maker billions of dollars in sales.
Nipping at Eli Lilly’s heels are both Celgene and Nuvilex, but of the three, the smallest of them all, has produced the best results in clinical trials using its living cell encapsulation. Nuvilex’s “Cell-in-a-Box” is a process that forms 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.
The process uses living cells, and Nuvilex takes a very specific type of cell to address a specific problem a patient suffers from. Scientists then wrap up cells in a type of cellulose, forming essentially “cotton” capsules with live cells inside that form this “platform” or bundled miniature “house” of cells about the size of the head of a pin. At that point, each bundled platform becomes much like a miniature cell factory with the ability to produce whatever is needed.
Nuvilex’s unique cell encapsulation has been used in two independent Phase II clinical trials in patients with advanced, inoperable pancreatic cancer. In those trials, the encapsulated cells were capable of converting the widely-used anti-cancer drug, ifosfamide, into its “cancer-killing” form.
Nuvilex’s most recent results were arrived at using a broader set of data, and in doing so, confirmed the results found in the first Phase I/II trial. Both trials offer sets of data that were done at different times, with different populations, and in different hospitals. In the first trial, one location was used; however the second Phase II trial expanded its database by using 4 different hospitals.
In the twenty-seven patients that were included in the trials, 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 the 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.
With the company currently prepping for its pivotal large scale Phase III trial in patients with advanced pancreatic cancer, these have to be exciting times for the small biotech. Nuvilex can put itself on the map in a very big way if it’s able to once again confirm the results found in the first two clinical trials. If the results are confirmed, the company’s “Cell-in-a-Box”-based treatment could become the “gold standard” for late stage, inoperable pancreatic cancer just as Gemzar has been for more than 15 years.
But, there is even more at stake for Nuvilex and many other biotech and pharmaceutical companies as well. If “Cell-in-a-Box” continues to perform as it has thus far, then the company’s living cell encapsulation technology will be in line to go to work in many other areas of need. It has already performed admirably in pre-clinical animal trials studying diabetes. In those animal studies, “Cell-in-a-Box” essentially became a type of “artificial pancreas” capable of producing insulin in diabetic rats by encapsulating live, insulin producing, pancreatic islet cells from pigs, and then implanting the encapsulated islet cells into the diabetic rats.
Both the pancreatic cancer trials and the studies in diabetes can go a long way to proving that Nuvilex’s “Cell-in-a-Box” could be the basis of treatments for some of the diseases that pharmaceutical firms are making drug after drug to treat.
Nuvilex’s COO, Dr. Gerald Crabtree noted “This is an exciting time to be at Nuvilex for all of us. We have the opportunity to help many people throughout the world that suffer from very serious, debilitating and even deadly diseases by developing treatments that are based on our cell encapsulation technology. I have been a part of some exciting developments in drug development, particularly in the cancer field, in my 40-plus year career, but I truly feel that the potential of the cell encapsulation technology could dwarf all of them.”
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