Written by ι Stock Market Media Group Staff — May 2, 2013
Nuvilex, Inc. (OTCQB: NVLX) has already produced impressive results from its two independent Phase II clinical trials in patients with advanced, inoperable pancreatic cancer. Two key results pulled from the data of those trials, are that the median survival rate was higher than that of the current gold standard for the disease and better than those of other competitors’ treatments when clinical trial reports are examined. Furthermore, the overall side-effect profile (toxicity) was much lower with Nuvilex’s treatment than those of competitors’ treatments.
Nuvilex’s pancreatic cancer treatment uses the company’s “Cell-in-a-Box” or living cell encapsulation technology along with the single anticancer drug ifosfamide. The encapsulated cells are capable of converting the ifosfamide into its cancer-killing form. Through two clinical trials, Nuvilex’s treatment has performed admirably with results that included a median survival time and one-year survival rate that were doubled as compared to historical data for Gemzar, the only drug to date approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer.
Digging deeper into those survival rate results, a finer point on the data would be to simplify it down to real numbers. At the time Nuvilex’s clinical trials were conducted, Gemzar’s historical data gave patients a median survival time of 5.5 months; whereas, Nuvilex’s treatment during the two clinical trials resulted in a median survival time of 11 months.
In January of this year, Celgene Corp. (NASDAQ: CELG) reported the results for its treatment for advanced pancreatic cancer at the American Society of Clinical Oncology’s (ASCO) Gastrointestinal Cancers Symposium in January. Celgene’s treatment includes gemcitabine (Gemzar) in combination with their drug Abraxane, a nanoparticle albumin-bound formulation of paclitaxel (Taxol).
Dr. Daniel Von Hoff, MD, Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute in Scottsdale, AZ and Consultant to Celgene made the presentation at the Symposium. Later in an interview with THE ASCO POST, a newspaper style publication of the American Society of Clinical Oncology (ASCO, an international organization), Dr. Von Hoff said:
“The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer. I have counted 33 phase III trials since 1990, and only 3 were positive. This has been a frustrating area.”
Celgene will probably soon seek approval from the FDA for the use of their gemcitabine/Abraxane combination as the “treatment of choice” for advanced pancreatic cancer. One of the major “selling points” for the approval of Celgene’s treatment will probably be that it gave about a 30% improvement in the median survival time of patients as compared to gemcitabine (Gemzar) alone. Median survival times for Eli Lilly’s (NYSE: LLY) drug Gemzar and Celgene’s combination still fall well short of those reported for Nuvilex’s treatment in its Phase II trials results, however.
A look at the one-year survival rate reported in the trials also favors Nuvilex. Compared to historical data for Gemzar, the cell encapsulation-ifosfamide combination doubled the one-year survival rate. Celgene’s treatment, on the other hand, improved the one-year survival rate by only 59% as compared to gemcitabine (Gemzar) alone.
In addition, Nuvilex’s treatment uses only the single drug, ifosfamide, while others engaged in bringing a new treatment for advanced, inoperable pancreatic cancer to market are using more than one. Why is this significant? As we mentioned in the open, the overall side-effect (toxicity) profile was low with Nuvilex’s treatment. The results showed no life-threatening or even serious side effects that could be attributed to the company’s treatment. Because Nuvilex’s treatment is a technology plus the drug ifosfamide, it is likely the severity of ifosfamide’s side effects was reduced as only one-third of its usual dose was used in the trials.
The Celgene treatment, however, used two drugs, Gemzar in combination with its own drug Abraxane. Since two drugs are used in Celgene’s treatment, the side-effect profile of the combination is quite severe. It was said to be “manageable,” but about 4% of the patients died from complications as a consequence of the treatment; this was also seen when Gemzar was used alone in their clinical trial.
One final point – in Nuvilex’s Phase II trials only a single implantation of encapsulated cells and only two treatments with ifosfamide (more than this are usually used when this drug is used in cancer treatment) were used and still the remarkable results noted above were achieved. By contrast, in Celgene’s Phase III trials with the Gemzar/Abraxane combination, many “courses’ of treatment were required to achieve their results.
Nuvilex is preparing for a late stage Phase III trial using its cell encapsulation-ifosfamide treatment in hopes of unseating Eli Lilly’s drug Gemzar as the gold standard for the treatment of patients with advanced, inoperable pancreatic cancer. Eli Lilly has raked in billions of dollars in sales of Gemzar since 1996, but, interestingly, by the time Nuvilex’s treatment is submitted for FDA approval, it may be Celgene’s treatment that Nuvilex’s combination of “Cell-in-a-Box” and ifosfamide is replacing.
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