PharmaCyte Biotech Successfully Completes Manufacturing of Clinical Trial Product
PharmaCyte Biotech, Inc., a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that its partner, Austrianova Singapore (Austrianova), has completed the first of two staggered and back to back manufacturing runs for the production of PharmaCyte’s clinical trial product.
The first manufacturing run has been completed successfully. A representative sample of frozen syringes filled with the encapsulated cells inside are in the process of being shipped to external testing laboratories for the release testing of the clinical trial product that is required by the U.S. Food and Drug Administration (FDA). The clinical trial product will be used in PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
Also, about two weeks ago, the second of the two manufacturing runs began. The cells from PharmaCyte’s Master Cell Bank (MCB) are reportedly growing well. The plan is to encapsulate them within the next week or two.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are exceedingly pleased that Austrianova has successfully manufactured PharmaCyte’s clinical trial product for our clinical trial in LAPC, and we’re equally as encouraged to hear that the second and final manufacturing run is proceeding as expected. During our recent shareholder update call, we committed to keeping our shareholders apprised of material developments related to PharmaCyte’s work in completing its Investigational New Drug application (IND). Today’s announcement is a major milestone towards the completion of that work.
“The efforts undertaken to meet this milestone were monumental and involved everyone associated with the technical aspects of the manufacturing process. We cannot be more thankful to our colleagues at Austrianova and those from PharmaCyte who were involved in the work. I feel strongly that we’re back on track to completing both of the required manufacturing runs that will generate the data needed to complete the IND.”
During PharmaCyte’s shareholder update call on September 20, 2019, it was reported that Austrianova was in the post-encapsulation phase of the first of two staggered and back-to-back manufacturing runs required by cGMP Validation, the company that is taking responsibility for releasing the clinical trial product into the U.S. for use in PharmaCyte’s upcoming clinical trial.
