PharmaCyte Biotech Completes Medical Manual for IND Filing

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 completed a medical manual that is pivotal to the completion of its Investigational New Drug application (IND) filing. 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.

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.”

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.

PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.

PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.

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