PharmaCyte Starts CypCaps Studies Sought by FDA

PharmaCyte Biotech says it has started additional studies sought by FDA to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps product for treating pancreatic cancer and the stability of the sequences. The company says it has already demonstrated that the enzyme is produced, that the expression of the enzyme is stable over time, and that the enzyme is functional.

It says FDA now has asked for the exact DNA sequence and configuration of the genetic augmentation responsible for the production of cytochrome P450 in the cells.

“This requires additional studies that necessitate a multi-prong approach, including the employment of a new, state-of-the-art, technique,” PharmaCyte says.

The company statement says the new studies will strengthen and extend the existing data that have been presented to FDA on the site of integration of the DNA encoding of the cytochrome P450 enzyme and data on cell stability.