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Inno Biologics Clones Cells for Nuvilex Trials

Will be tested in pancreatic cancer trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The cloning of the cancer-drug-activating cells required for Nuvilex, Inc.’s future Phase III trials has begun at Inno Biologics’ cGMP facilities. Inno Biologics received four vials of frozen cells capable of converting the anticancer prodrug ifosfamide into its active cancer-killing form. The cells were successfully thawed and approximately 97% of the cells were found to be viable. The contents of the vial were tested and found to be free of bacteria, fungi, and mycoplasma.
 
The cloning process consists of growing cells in multiple microplates to produce a large number of discrete clones. The best clones for Nuvilex’s oncological purposes will be propagated to obtain large numbers of cells required for the late-phase trials.
 
Nuvilex’s president and chief executive officer, Dr. Robert F. Ryan, said, “This is a critical juncture on the path to our planned late-stage clinical trials. The important steps have and are being carefully planned and timed so as to bring us forward as quickly as possible for our planned pancreatic cancer clinical trials. The high level of viability seen on initial examination by Inno Biologics shows that the cells were grown and stored well by ViruSure prior to thawing. We are confident the companies we have chosen to take care of each of the activities are both competent and well equipped to complete the work.”

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