Pharmacyte Biotech Inc (OTCMKTS:PMCB) completed testing of CypCap as required by the US FDA in a three-month stability study. CypCap passed all the tests and complies with FDA. The company will use CypCap in a clinical trial in patients with LAPC (Locally advanced inoperable pancreatic cancer).
Kenneth L. Waggoner, CEO of Pharmacyte, said the company is excited to complete CypCaps, a cell in box encapsulated product, testing in a three-month study. The product passed all the required tests in the first three months as part of a 24-month study.
Determines shelf life
The ongoing study is conducted to find out the shelf life of the product in compliance with FDA as needed for all medical products. Pharmacyte will include data from this study in IND submission. The company will conduct an additional 6 months study to determine the long term shelf life of the drug and submit to FDA. However, Pharmacyte need not include this data in IND filing.
The study is conducted on all medical products like vaccines and live-cell therapies because they get deactivated over time. Pharmacyte conducted tests on CypCaps after they are frozen post manufacturing for 3 months at -80 degrees centigrade.
Austrianova conducts certain tests
Austrianova engages in conducting some tests like label integrity, the integrity of the capsule, biological activity of cells inside the capsule, and cell count. Pharmacyte conducts pH measurement and sterility tests at contract labs.
Completes CCI test
Pharmacyte completed a CCI (Container Closure Integrity) test for its CypCaps in compliance with the US FDA. With this, the company completed all the tests required by the FDA to begin a clinical trial of CypCaps to treat patients suffering from LAPC.
Waggoner said the company is excited to complete the CCI test of CypCaps. Its contractors will complete balance documentation work for IND filing.
Scope of work for contractors
Pharmacyte along with its contractors will complete and finalize Drug master file, clinical overview, non-clinical overview, environmental analysis, plan for general investigation, informed consent, pharmacy manual, supporting documents, trial protocol, introduction summary, and study reports for IND submission:
Regulatory agencies worldwide mandate testing of medical products to ensure they are live after a long period of inactivity.