Eli Lilly & Co. (NYSE: LLY) has parlayed its cancer drug Gemzar® or gemcitabine into well over $10 billion since it gained approval to treat advanced, inoperable pancreatic cancer back in 1996. Meanwhile, Nuvilex, Inc. (OTCQB: NVLX) has its eyes on a piece of that billion dollar pie with the company’s live-cell encapsulation based treatment for pancreatic cancer. But, it may be another disease that has these two biotech’s going head to head for years to come – diabetes.
Nuvilex recently entered the diabetes arena when it acquired the exclusive worldwide licenses associated with live-cell encapsulation-based diabetes treatments. In a recent interview with Bloomberg, Eli Lilly’s president of Lilly Diabetes, Enrique Conterno, said the company is preparing to introduce as many as four new therapies by 2016.
Nuvilex and Eli Lilly aren’t strangers as both are engaged in treatments for advanced, inoperable pancreatic cancer and both have treatments in mind for the rapidly growing diabetes epidemic. This past summer Nuvilex acquired the exclusive worldwide licenses associated with the live-cell encapsulation-based pancreatic cancer treatment the company will be using in its future Phase III clinical trials. Now, with this most recent acquisition of the same exclusive worldwide rights, but this time associated with diabetes, Nuvilex controls both the cancer and diabetes markets when it comes to any treatment using this live-cell encapsulation-based technology.
Nuvilex will assuredly look to get its diabetes treatment into human clinical trials in the future after animal studies using the live-cell encapsulation-based technology, created a type of “artificial pancreas.” An “artificial pancreas” was developed that controls blood sugar levels and eliminates the need for insulin treatment.
This data comes from a 6-month animal study where pancreatic islet cells from pigs were encapsulated using Nuvilex’s technology and the capsules containing the islet cells were then implanted into diabetic rats. Within only a short time, 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 – all of this without the use of immune-system-suppressing drugs.
This “proof-of-principle” study verifies that the type of live cell encapsulation used by Nuvilex is also applicable for the development of treatments for diseases other than cancer. As the company moves forward in the diabetes arena, expanded animal studies will be conducted; these studies should ultimately lead to clinical trials in humans with insulin-dependent diabetes.
It was data from two independent Phase II clinical trials that served as an introduction of the two companies. Nuvilex, the small upstart biotech showing better results with its treatment when compared to Eli Lilly’s long-standing pancreatic cancer drug gemcitabine (Gemzar®), has turned into a great David versus Goliath story as it unfolds. This sparring match will likely continue well into the future with Eli Lilly’s expected diabetes’ offerings meeting somewhere along the clinical trials path with Nuvilex’s live-cell encapsulation-based diabetes treatment.