On June 23, 2020 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, reported 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) (Press release, PharmaCyte Biotech, JUN 23, 2020, View Source [SID1234561409]).
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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: View Source