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.
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