PharmaCyte Updates Status Of Investigational New Drug Application For Pancreatic Cancer Candidate

PharmaCyte Biotech Inc PMCB updated its activities to lift the FDA's clinical hold on PharmaCyte's treatment for locally advanced, inoperable pancreatic cancer (LAPC). 

• After submitting an initial Investigational New Drug Application (IND), the FDA requested additional studies and information as a prerequisite for approval of PharmaCyte's IND. 
• Several additional studies and assays have been completed; others are pretty lengthy and underway or are slated to begin soon. 
• PharmaCyte has completed a product stability study after 3, 6, 9, 12, and 18-months of storage frozen at -80C on PharmaCyte's clinical trial product, CypCaps, including container closure integrity testing for certain timepoints. 
• The next time point in this ongoing stability study will be at 24 months, ready to commence, and data will be available in the coming weeks.
• Related: Why Is PharmaCyte Biotech Stock Moving Higher In Premarket Thursday?
• PharmaCyte has designed and commenced 8 biocompatibility studies, 6 of which have been completed successfully. The remaining 2 studies are underway. 
• Finally, the Company has designed a study in pigs to address biocompatibility and long-term implantation and dispersion of the CypCaps.
• In September, PharmaCyte announced the first test results of the biocompatibility studies of its CypCaps trial.
• Price Action: PMCB shares are down 4.23% at $2.04 during the market session on the last check Monday.