On January 22, 2020 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 undergone and passed all 10 of the necessary "release tests" required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 22, 2020, View Source [SID1234553417]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
PharmaCyte’s partner, Austrianova Singapore (Austrianova), is now completing and signing the paperwork to issue PharmaCyte a Certificate of Analysis for each batch of the company’s clinical trial product. Austrianova will also be turning over all of the completed batch records to PharmaCyte for both production runs that tested the company’s clinical trial product for the "functionality" of the encapsulated cells and the "safety" of the clinical trial product. These tests will provide essential data for PharmaCyte to complete its Investigational New Drug application (IND) to the FDA to request approval for our planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "After completing the production of our clinical trial product, it is extremely good news to learn that our capsules and the live cells inside are functioning and safe to put inside patients in our upcoming planned clinical trial in locally advanced, inoperable pancreatic cancer. There were 20 tests in total over both batches, and our clinical trial product passed all of them. This proves that our years of hard work and working through each challenging hurdle was well worth it. We now eagerly await the two Certificates of Analysis and the records from both batches from Austrianova so that we can begin to compile and enter that data into our IND application."
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