Clinical TrialJul 29, 2026, 05:01 PM
PharmaCyte Biotech Addresses FDA Clinical Hold for Pancreatic Cancer IND
AI Summary
PharmaCyte Biotech, Inc. is focused on developing cellular therapies for cancer using its Cell-in-a-Box® technology. The company is actively working to address an FDA clinical hold placed on its Investigational New Drug (IND) application for a planned clinical trial in locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC). The FDA has requested additional data and studies, including sequencing, stability, and biocompatibility, which the company is diligently completing. A Strategic Scientific Committee is also reviewing risks and development programs, leading to reduced spending.
Key Highlights
- Developing cellular therapies for cancer using proprietary Cell-in-a-Box® technology.
- FDA placed a clinical hold on Investigational New Drug (IND) for pancreatic cancer (LAPC) in October 2020.
- FDA requested additional sequencing data, stability studies, and biocompatibility assessments.
- Company completed required product stability studies and Master Cell Bank stability studies.
- Confirmed exact sequence of Cytochrome P450 2B1 gene and its stability.
- Completed 8 of 10 requested biocompatibility studies; others underway.
- Strategic Scientific Committee reviewing development programs; licensed patents from SG Austria have expired.
- Spending on development programs curtailed until strategic review is complete.
Price Impact