PharmaCyte Biotech Inc. (OTCMKTS:PMCB) has announced the successful completion of a vital pyrogenicity testing that is a requirement by the FDA for the encapsulation material employed in manufacturing the company’s Cell-in-a-Box (CypCapsTM) capsules.
PharmaCyte planning to submit IND for CypCaps for inoperable pancreatic cancer
The Company’s CEO Kenneth Waggoner indicated that they were sure that the CypCaps will be non-pyrogenic, and they were proud to complete the study. He added that the focus of the company is to submit an IND for the planned second phase clinical study in inoperable locally advanced pancreatic cancer. He added that as the company competes for each test, a team of consultants and experts have been compiling the information on the completed tests to create the IND package quickly.
Usually, medical products delivered into the body should be non-pyrogenic. Progens are fever bringing components that can result in influenza-like signs as well as other side effects. Mostly they are endotoxins produced by bacteria, although sometimes nonbacterial material can be pyrogenic. The encapsulation procedure utilizes tested and endotoxin-free starting material, but sometimes the technology can introduce some pyrogens not derived from bacteria in encapsulation of live human cells, thus the need for testing.
The developer of the PCR test for SARS-CoV-2 offers insight into the tech
Recently the company signed a licensing agreement on coronavirus test kits technology with Hai Kang. The founder of the Hong Kong-based Hai Kang, Albert Cheung Hoi Yu, is no stranger to this kind of technology. He has been fast and precise in his response to global viral outbreaks such as SARS H1N1 virus, Avian flu, and now COVID-19.
While speaking about the test, his team developed for SARS-CoV-2 Hoi Yu said that it is different in that it employs an Enhanced Real-Time PCR method. Usually, there are two methods in testing for the virus, which are antibody-based testing and real-time PCR test. PCR testing detects viral RNA through probes and primes, and in the ERT-PCR test, the technology identifies the probes and primers that are specific for SARS-CoV-2.