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# PharmaCyte IND Safety Report for Pancreatic Cancer Drug
- URL: https://www.fdaweb.com/pharmacyte-ind-safety-report-for-pancreatic-cancer-drug/
- Published: 2018-11-15T12:00:00.000Z
- Updated: 2026-09-15T00:44:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142837

PharmaCyte Biotech says it has completed an FDA-required formal report on safety studies using a pig model that were undertaken before getting the agency to sign off on the first clinical trial in humans using its cellulose-based capsules that contain live genetically altered cells which activate the anticancer prodrug ifosfamide. The clinical trial will evaluate the therapy for treating locally advanced, non-metastatic, inoperable pancreatic cancer. “These large animal studies, which had to be retrieved from locations in several countries in Europe, demonstrate the safety of delivering capsules to the blood vessels (vasculature) leading to the pancreas in pigs and are supported by the initial clinical trial data generated to date, primarily from trials in Germany,” the company says.

PharmaCyte says its therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the cancer site.