PharmaCyte Biotech Inc. (OTCMKTS:PMCB) has announced the successful completion of its 12-months product stability testing for the CypCaps™ final clinical trial product as required by the US FDA. The product will be used in PharmaCyte’s planned clinical stud to treat locally advanced, inoperable pancreatic cancer once the FDA lifts the clinical hold on the company’s Investigational New Drug Application. (IND).
CypCaps™ passes stability tests
Kenneth L. Waggoner, PharmaCyte’s CEO, commented in the 12-month stability test, saying that they are delighted with CypCaps™ completing all the necessary testing tests successfully. He added that the product has been demonstrated to be stable and active following storage at -800C for over a year. Waggoner added that they will continue the study to determine CypCaps™’s Shelf life. He added that the data has been exceptional for a product of such kind.
The company had previously reported that the stability study was designed to determine the Cell-in-a-Box encapsulated cell product; CypCaps™’s shelf life when stored at -800C. After storage at -800C for 12 months, the analysis showed that the unfrozen CypCaps™ passed all tests, including enzyme activity, cell potency, cell viability, capsule appearance, label check, PH, and integrity. Most importantly, the 12-month data and future longer-term shelf life analyses time points such as the next, which will be evaluated after 18 months of storage at -800C, will be reported to the FDA. The ongoing stability study commenced before submitting the IND to the FDA, with the data forming part of the package of information and data from additional studies required by the FDA.
Encapsulated living cells have shelf-life challenge
It is important to note that shelf life has been a challenge for medicinal products that contain living cells. A survey of European biomedical and biotech companies that create advanced medicinal products containing living cells such as CypCaps™ reveals serious challenges shelf-life challenges for such products. Interestingly, lab data on non-GMP-produced encapsulated cells reveal that Cell-in-a Box products shelf-life t -800C could be more than one year.