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Nuvilex, Inc. Moves Closer to Head to Head with Eli Lilly in Phase III Clinical Trials

Nuvilex, Inc. Moves Closer to Head to Head with Eli Lilly in Phase III Clinical Trials

Written by ι Stock Market Media Group Staff — July 25, 2013

Nuvilex, Inc. (OTCQB: NVLX) is currently preparing the way to challenge Eli Lilly’s (NYSE: LLY) blockbuster cancer drug, Gemzar, and doing so with the knowledge that in two independent mid-phase clinical trials, the company’s treatment involving its proprietary living cell encapsulation technology has outperformed the pharmaceutical giant.  Nuvilex has produced better results when compared to historical data for Gemzar, and now the company is ready to use real time, head to head data to prove its treatment is superior to Eli Lilly’s.

Last week Nuvilex moved one step closer to going head to head with Eli Lilly when it completed a blockbuster acquisition.  The deal strengthened the company’s hand dramatically, and now Nuvilex owns exclusive worldwide licenses associated with the live-cell encapsulation-based pancreatic cancer treatment that it will use to go head to head with Eli Lilly.  Additionally, these licenses include worldwide rights to utilize the live-cell encapsulation platform technology to develop treatments for any and all cancer types, regardless of the cell type encapsulated.

About $25-million have been invested in two 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, Nuvilex has put almost another $2-million into furthering the development of the cell encapsulation technology itself.

This investment for the Silver Spring, Maryland-based biotech was made for just this challenge.  Gemzar, the standard single drug for pancreatic cancer patients equates to about $1.4-billion annually to Eli Lilly.  There is a lot at stake in the future Phase III clinical trials – for Eli Lilly, for Nuvilex and for cancer patients who are looking for a better treatment than the current single agent “gold standard.”  One has to imagine with the data already on the table that this is a head to head matchup that Nuvilex greatly anticipates while Eli Lilly might dread the end results.

Why is Nuvilex so anxious to get into its Phase III clinical trials?  Well, a cursory look into the significant results from two 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 almost a DOUBLING of the Median Survival Time and the One-Year Survival Rate 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.  There was no damage registered to the tissues near the capsules.  And, important to any therapy involving transplanted cells – the cells within the capsules were protected from attack by the patients’ immune systems, and the cells inside the capsules were alive and functioning even after more than two years.

In the company’s future Phase III trials, Nuvilex’s pancreatic cancer treatment will be compared directly with Gemzar and historical data will no longer be used.  The company says where only two cycles of ifosfamide were used in the Phase II trials, for the Phase III trials, more than two cycles may 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’s 17-year reign as the single agent “gold standard” for the treatment of this devastating disease.  This would clearly be good news for patients suffering from the disease, and it would be blockbuster news for Nuvilex’s shareholders.