Q. What makes your platform technology, Cell-in-the-Box, a value proposition?
KENNETH:
Cell-in-a-Box® is a remarkably versatile platform technology that can be used to develop treatments for all kinds of serious diseases, such as cancer and insulin-dependent diabetes. Cell-in-a-Box® is a type of technology where genetically modified living cells are encapsulated in small, pin-head-sized, spherical protective cocoons. These cocoons, or capsules, have pores in their outer shell that allow nutrients to enter the capsules to nourish the cells inside and to allow waste products from those cells to leave the capsules. The capsules are protective of the cells inside them because their pores are too small to allow the encapsulated cells to escape, where they would be destroyed by the patient’s immune system, and the pores are too small to allow the cells from the patient’s immune system to enter the capsules and destroy the cells inside.
Cell encapsulation has been around for many years. A number of materials have been used, the most common being alginate which is derived from seaweed. PharmaCyte Biotech is using cellulose sulphate for its cell encapsulation. Cellulose sulphate offers a number of advantages over other encapsulation materials because it is derived from a naturally occurring plant derived-polymer that is relatively easy to obtain at reproducible quality and is free from impurities. In addition, it has excellent biocompatibility. Cells in the capsules survive well and even grow within the capsules. Further, once the capsules are implanted into a body, they are not rejected by the body’s immune system and there is no immune or inflammatory response against the capsule material or the cells within the capsules. Cellulose sulphate encapsulated cells have already been tested in two human clinical trials and have been shown to be safe. In these trials, the cells in the capsules allowed lower, non-toxic doses of a chemotherapy drug to have equal or greater anti-tumor effects than standard, toxic doses of the same drug.
The Cell-in-a-Box® capsules are extremely robust and do not break down even after two years in a human body. The strength of our capsules allows them to be implanted using a needle or a catheter without damage to the patient. In addition, capsules containing living cells can be frozen and stored for more than 5 years, and when thawed, the frozen cells come back to life with more than 95% viability. These properties are important for long-term storage and for shipment over long distances as would be required for the commercialization of our encapsulated products. To our knowledge, no other form of live-cell encapsulation produces capsules that possess these unique properties. Without the ability to freeze the encapsulated cells, the capsules would need to be used almost immediately after production. This unique advantage alone sets PharmaCyte Biotech apart from any other cell encapsulation company in the world.
