On November 15, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a U.S. Food and Drug Administration (FDA) required formal report on the safety studies conducted by Bavarian Nordic using a pig model that were undertaken before the first clinical trial in humans using cellulose-based capsules that contain live genetically altered cells which activate the anticancer prodrug ifosfamide (Press release, PharmaCyte Biotech, NOV 15, 2018, View Source [SID1234531357]). The voluminous information contained in the formal report is another complicated Investigational New Drug Application (IND) component requested by the FDA to be included in the IND before the start of the clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).
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A formal study report, including all the data from the previously performed porcine animal studies, has been completed and independently reviewed and verified. The original data was published in part in the journal Pancreatology, but the confines of that scientific publication did not allow for the complete volume of data to be included in the journal article, necessitating several components of the studies to be woven together in a formal study report according to FDA guidelines. The original data was compiled and independently reviewed by Facet Life Sciences with the support of original members of the team that performed the porcine experiments, including Prof. Matthias Löhr who was the Principal Investigator for the first two pancreatic cancer trials with what has evolved into PharmaCyte’s current treatment for pancreatic cancer. The final study report has now been signed off on by two members of the original team, Prof. Udo Losert and Prof. Walter H. Günzburg, and will be submitted to the FDA as part of the IND dossier required for approval for the commencement of PharmaCyte’s planned clinical trial in LAPC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "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 formal study report allows us to submit the complete set of data in the appropriate fashion to the FDA as part of our IND submission for our upcoming LAPC trial in the U.S."