3 September 2020 - - US-based biotechnology company PharmaCyte Biotech, Inc. (OTCQB: PMCB) has submitted an Investigational New Drug application to the US Food and Drug Administration for a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer, the company said.

The proposed multicenter, randomized, open-label Phase 2b clinical trial is intended to evaluate the efficacy and safety of CypCaps (genetically engineered human cells encapsulated using the Cell-in-a-Box technology) in combination with low doses of the chemotherapy prodrug, ifosfamide, as compared to chemoradiation therapy with capecitabine plus external beam radiation therapy or stereotactic body radiation therapy alone.

The study population will consist of approximately 100 patients. Patients will be randomised in a 1: 1 ratio to either treatment with the study therapy or a comparator.

The randomisation will be stratified by previous treatment (Abraxane plus gemcitabine or FOLFIRINOX) and the control arm choice (capecitabine/EBRT or SBRT alone).

The primary objective will be determined by progression free survival. The secondary objectives for this study are to determine if CypCaps plus low-dose ifosfamide will: increase overall survival; increase objective response rate; increase the rate of conversion of the pancreatic tumor from inoperable to operable; decrease the pancreatic cancer tumor marker CA 19-9; and improve a patient's quality of life.

In addition, this clinical trial will assess the safety and tolerability of CypCaps plus low dose ifosfamide.

PharmaCyte Biotech, Inc. (PharmaCyte) is a clinical stage 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 liver 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 also considering the use of genetically modified stem cells to treat diabetes. The encapsulation of whatever cell line shows the most promise will be done using the Cell-in-a-Box technology.

Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a "bio-artificial pancreas" for purposes of insulin production.