On November 25, 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 an update on the completed tests that are part of the U.S. Food and Drug Administration (FDA) required "release testing" related to the company’s first manufactured batch of its clinical trial product to be used in its planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, NOV 25, 2019, View Source [SID1234551661]).
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There are 10 total tests that make up the company’s "release testing." To date, 5 of those 10 tests have been completed and all 5 have passed, including 4 of the 5 tests being conducted by third-party laboratories on the first manufactured batch of PharmaCyte’s clinical trial product.
PharmaCyte’s partner, Austrianova Singapore (Austrianova), is conducting 5 of the tests, which are all related to the "functionality" of the encapsulated cells, while third-party laboratories are conducting the remaining 5 tests, which are all related to the "safety" of the company’s clinical trial product.
Among those successful tests was the "enzymatic activity" test that was performed by Austrianova. The last remaining test being conducted by a third-party laboratory is still in progress and is being conducted in the Netherlands by Eurofins.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the release testing, "We continue to be pleased that we’ve completed all of our manufacturing runs successfully and that we have a clinical trial product. Now, we follow that initial news with more good news that all of the release testing from the first successful manufacturing run carried out so far has been completed successfully.
"While the release testing is being conducted, we’re working to finalize the Protocol, the Investigator Brochure, the Pharmacy Manual and the Angiography Guidelines. We are also engaged in a selection process for a vendor to handle our clinical drug supply chain. All of these tasks should be complete by the time we receive the data from all of the release testing being conducted on the first and second manufacturing runs.
"After we receive all of the results from release testing, we will enter the data from those results into our Investigational New Drug application (IND) and then submit an entire package of information and supporting documents to the FDA for our planned Phase 2b clinical trial in LAPC."
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