On May 4, 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 has completed a medical manual that is pivotal to the completion of its Investigational New Drug application (IND) filing (Press release, PharmaCyte Biotech, MAY 4, 2020, View Source [SID1234556969]). The manual, "Angiography Manual – Transarterial Chemoinfusion of the Pancreas" (Angiography Procedure Manual), will be used to guide Interventional Radiologists on the placement of a catheter that begins at the femoral artery in the leg and ends as close to the pancreatic tumor as possible in patients participating in PharmaCyte’s planned Phase 2b clinical trial. By following the directions in this manual, Interventional Radiologists will be able to precisely place the Cell-in-a-Box capsules inside patients.
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The Angiography Manual was prepared by a team of medical professionals. The initial version was prepared by Dr. David H. O’Leary, an Interventional Radiologist and Senior Vice President of the Medical Department at Medpace (PharmaCyte’s Contract Research Organization (CRO)). Dr. O’Leary’s version was then reviewed by Dr. Manuel Hidalgo, the Principal Investigator (PI) for PharmaCyte’s planned Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer (LAPC), and Dr. Matthias Löhr, who was the PI for the first two clinical trials using PharmaCyte’s treatment for LAPC.
Dr. Jens-Christian Kröeger, who was the Interventional Radiologist during the two earlier clinical trials provided valuable assistance in the preparation of the Angiography Manual, and Dr. Löhr was able to work side-by-side with Dr. Kröeger as the angiography procedure was performed during those trials. A final review of the Angiography Manual was performed by Dr. Bradley Pua, an Interventional Radiologist with Weill Cornell Medicine and a colleague of Dr. Hidalgo.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, stated, "We are deeply indebted to all of the physicians who contributed to the preparation of the Angiography Procedure Manual. This very important medical document makes up a crucial component of our IND and gets us one step closer to submitting our IND to the U.S. FDA, as we’re diligently completing the last remaining items for that submission."