Eye Catching News Just Hit The Wires. PharmaCyte Biotech, Inc. (PMCB) , a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has successfully completed the crucial pyrogenicity testing that is required by the U.S. Food and Drug Administration (FDA) of the encapsulation material used to manufacture PharmaCyte’s Cell-in-a-Box® capsules (CypCaps™). The capsules, which house live human cells, passed the test and are deemed non-pyrogenic. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed pyrogenicity testing, "While we never doubted that the capsules would be pyrogen free, we are very pleased that this vital FDA-required study has been successfully completed. We continue to remain centrally focused on submitting an Investigational New Drug application (IND) to the FDA. To that end, our team works every single day to complete the necessary items that will allow PharmaCyte to submit an IND for its planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer. Meanwhile, as each test and item are completed, our team of experts and consultants is diligently compiling the data from these completed items and creating our IND package in real time." All medical products that are delivered to the body have to be pyrogen free. Pyrogens are fever inducing substances that can cause side effects and influenza-like symptoms. Substances produced by bacteria (endotoxins) can be pyrogens, but other nonbacterial substances can be pyrogenic too. The Cell-in-a-Box® encapsulation procedure uses starting materials that have been tested and shown to be endotoxin free. However, the encapsulation process and machinery used for production of PharmaCyte’s CypCaps™ might potentially introduce nonbacterial pyrogens into the material used to encapsulate the human cells. The United States Pharmacopeia1 as well as the FDA2 require that advanced therapeutic medicinal products like CypCaps™ have to be tested for pyrogens. In order to comply with these regulatory requirements, PharmaCyte requested Austrianova to produce a dedicated batch of empty cGMP capsules for pyrogenicity testing. It was an involved and time-consuming process to engineer empty cGMP capsules for the pyrogenicity testing. Once the empty capsules were manufactured, they were sent to Nelson Labs in Salt Lake City, Utah, for testing. A protocol had to be developed for the unique test material that would be used in rabbits. The capsules were extracted in saline at 50C for 72 hours and the extract was then injected into rabbits. This was done in order to determine if the injected matrix caused a fever. The results of the study have just been released. PharmaCyte can make the long-awaited announcement that the capsules passed the test and are deemed non-pyrogenic.
