PharmaCyte Biotech Inc (PMCB)

[Babubd]

Slapping asks. EPIC move coming! Fortunes will be made. Only strong hands will collect thousands of Dollars in coming days!! $PMCB

Flippers and shorts will regret and shed tears in coming days.

KNOW WHAT YOU OWN

PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product

PharmaCyte Biotech, Inc. (OTCQB: 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 commenced additional physical parameter testing of its CypCaps® product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA).

The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte’s encapsulated cells (CypCaps) to be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). One method involves pressing down on the capsule and measuring either the pressure required for it to burst, or for it to deform. Since the CypCaps are very small, special machinery that can measure such tiny changes has to be used to demonstrate this. The necessary machinery is now being incorporated as a quality control test for the CypCaps.

The second method involves letting water flow into the CypCaps, effectively “blowing them up.” The point at which the capsules explode will be used as a quality control parameter.

Previous work has shown the pressures and water conditions used in these tests to be well outside of the normal conditions encountered by the capsules inside the human body, so these tests are designed to simulate hypothetical conditions.

Earlier studies have shown that the capsules do not burst even when placed under very high pressure. Further, even in the very unlikely event that the capsule could break open, the cells inside will be recognized as foreign bodies by the immune system. Also, the encapsulated cells are primed for their suicide since they express the cytochrome P450 gene and thus would be killed by the low dose ifosfamide given as part of the treatment for LAPC.

Thus, these FDA mandated studies can be seen as additional release tests to ensure the reproducibility of the CypCaps.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We are pleased to announce the development of these two new quality parameters and their incorporation into the quality testing as one of the additional studies requested by the FDA. In the meantime, PharmaCyte continues to work with its partners to address the other issues raised by the FDA that led to the clinical hold.”

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer.

https://www.otcmarkets.com/stock/PMCB/news/PharmaCyte-Biotech-Begins-Physical-Testing-of-CypCaps-in-Response-to-FDA-Recommendations-for-its-Clinical-Trial-Product?id=283334

PharmaCyte Biotech Successfully Completes 9-Month Stability Study

https://ca.finance.yahoo.com/news/pharmacyte-biotech-successfully-completes-9-141500362.html