PharmaCyte Biotech Inc. (OTCMKTS:PMCB) has announced that its final major “Stability Study” required by the FDA for its submission of an Investigation New Drug application has started.
Stability Study to run for two years
The “Stability Study” will be a rolling 2-year study seeking to evaluate the company’s frozen clinical study product produced by Austrianova Singapore. The company seeks to demonstrate the product’s performance in locally advanced inoperable pancreatic cancer patients after being frozen and then thawed. Although the study will go on for two years, the FDA, on the other hand, needs 3-months stability data for inclusion in the IND submission.
So far, it has been around three months since the Stability Study tests began from the day a Certificate of analysis was issued for a second manufacturing run. It is expected that the run will go on for 24 months, and the data will be availed to the FDA once available.
Most of the Stability Study tests are the same as those conducted as “release testing.” These tests enabled the issuance of the Certificate of Analysis to PharmaCyte by Austrianova. The certificate is for second manufacturing run following the success of two back to back runs.
Test to be conducted at different time points
The tests will be taken at different time points. They will either be 0 months, which is the release testing. This will be followed by 3, 6, 9, 12, 18, as well as 24 months, where label integrity will take place. The company will conduct transgene marker sequencing at 0, 6, 12, and 24 months.
Kenneth Waggoner, the CEO of PharmaCyte, while commenting on the study, indicated that they had to wait three months to begin the study. This is to conduct a second manufacturing run necessary for the submission of an IND. Waggner added that they are finally there but have to wait for another 24 months to complete the study and submit IND.