PharmaCyte Biotech Provides IND Submission Update for Pancreatic Cancer Clinical Trial

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, today announced that it is closing the gap in completing its Investigational New Drug application (IND) for its planned clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are pleased to report that the major challenges we faced in completing the IND have now been overcome. The remaining work no longer involves research and development or manufacturing. The remaining work now resides with our consultants to complete the documents required for the IND submission.”

The Stability Study tests, which include the Container Closure Integrity test, are underway. These are the tests for the first “time point” in the two-year Stability Study. Successful data from these tests are required by the U.S. Food and Drug Administration (FDA) and will be incorporated into the IND.

Most of the remaining work is being handled by PharmaCyte’s consultants. Set forth below is a list of the major items to be finalized by PharmaCyte and its consultants before PharmaCyte submits the IND to the FDA.

• Trial Protocol
• Investigator’s Brochure
• Environmental Analysis
• General Investigation Plan
• Introduction Summary
• Nonclinical Overview
• Clinical Overview
• Nonclinical Written and Tabulated Summaries
• Drug Master File
• Pharmacy Manual
• Informed Consent
• Study Reports and related information of prior clinical studies pertinent to LAPC
• Regulatory Publishing of the IND and supporting documents

While this is not a complete list of all of the remaining tasks, it identifies the critical ones. However, there are no further pre-clinical tests remaining to commence before submitting the IND to the FDA.

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

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. In addition, PharmaCyte is developing and preparing to obtain approval from the FDA to commercialize a COVID-19 diagnostic kit to meet a critical unmet medical need for such kits during the current pandemic.