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Nuvilex, Inc. Enters Most Important Step of Phase III Trials Outside of Patient Enrollment

Nuvilex, Inc. Enters Most Important Step of Phase III Trials Outside of Patient Enrollment

Written by ι Stock Market Media Group Staff — October 1, 2013

When Nuvilex, Inc. (OTCQB: NVLX) announced that it had contracted Inno Biologics to generate cell clones that will be the basis of the company’s future Phase III clinical trials in advanced, inoperable, pancreatic cancer, many investors may not have realized this is the most vital step in the process of beginning the company’s future late-stage clinical trials next to the actual enrollment of patients.  Nuvilex’s success in its future trials, and quite frankly its future in general, will be pinned on its recently acquired live-cell encapsulation based treatments. 

According to Nuvilex’s COO, Dr. Gerald Crabtree, the cloning of cells by Inno Biologics represents the crucial initial step in obtaining sufficient numbers of cells to carry out the company’s late-phase clinical trials.  And, if anyone understands clinical trials it’s Dr. Crabtree who has spent 40 years fighting in the oncology arena and was a part of the team at Bristol Myers-Squibb that brought Taxol through clinical trials and to market. 

Without these cells, there will be no cell encapsulation, and as Nuvilex tries to put its live-cell encapsulation based treatments on the map, this work at Inno Biologics couldn’t be any more important to the company’s future. 

Dr. Crabtree said of the work to be done at Inno Biologics, “The fact that this step is indeed being taken illustrates Nuvilex’s full and absolute commitment to doing its utmost to develop an effective and safe treatment for those suffering from this devastating and deadly disease.”

Nuvilex’s COO explains that the process will begin with 22P1G cells being sent to Inno Biologics by Nuvilex via SG Austria.  The 22P1G cells are the cells that have high activity of the enzyme CYP2B1, and this is the enzyme that activates the widely used anticancer prodrug ifosfamide into its “cancer-killing” form.

After the cell lines are obtained by Inno Biologics, they will generate about 100 clones from them, and these clones will then be tested to determine which are “best” for Nuvilex’s pancreatic cancer trials. Dr. Crabtree says about 10% of the clones will be selected, and then additional comprehensive characterization of these clones will be done to ensure that they are satisfactory, in all respects, for Nuvilex’s clinical trial purposes.  It is from these selected clones that the requisite numbers of cells for the trials will ultimately be produced.

The clones of cells developed by Inno Biologics will then be expanded to finally obtain the large number of cells required for the clinical trials.  As the company explains it, these cells will then be encapsulated and the encapsulated cells will be used, together with ifosfamide, as the company’s treatment, in the clinical trials.

Dr. Crabtree says the work to produce the eventual cell lines for the company’s future trials is as important as it gets for Nuvilex.  “The satisfactory completion of the work to be done by Inno Biologics will be a major, mandatory step in finally producing sufficient numbers of ifosfamide-activating cells for encapsulation prior to initiation of Nuvilex’s clinical trials in patients with advanced, inoperable pancreatic cancer.”

For Nuvilex investors, this represents exciting times as the company has moved to contract with GMP-compliant firms in Inno Biologics to develop the cell lines, and Fisher BioServices to store representative samples of the cells for the long term. 

With Celgene’s recent FDA approval of Abraxane plus gemcitabine as a treatment for advanced, inoperable pancreatic cancer, Nuvilex can make its mark in the space with successful Phase III clinical trials that continue to show the same data the company has seen in its two completed mid phase trials.  And, there is no better way to generate success than to build a successful foundation from which Nuvilex’s entire clinical trial will be based.