On December 23, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that both batches of the company’s manufactured clinical trial product have now passed 7 of the 10 completed "release tests" per batch required by the U.S. Food and Drug Administration (FDA), including the test for "enzymatic activity" on both batches (Press release, PharmaCyte Biotech, DEC 23, 2019, View Source [SID1234552589]).
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "As we expected, each batch of our clinical trial product is performing well during ‘release testing.’ There are 10 tests in total being performed on each batch that was manufactured by Austrianova. These tests will provide essential data for us to complete our Investigational New Drug application (IND). This data, together with other information and data we are developing, will enable us to submit the IND to the FDA to request approval for our planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). There are 3 tests that remain outstanding on each batch before we are completely done with release testing."
PharmaCyte’s partner, Austrianova Singapore (Austrianova), is conducting release tests related to the "functionality" of the encapsulated cells, while third-party laboratories are conducting release tests related to the "safety" of the company’s clinical trial product.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source