PharmaCyte Biotech CEO Discusses Navigating Testing and IND Submission During COVID-19 Pandemic

NEW YORK, NY, March 26, 2020 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) continues to work with consultants to prepare its Investigational New Drug application (IND).  At the same time, PharmaCyte is reportedly completing the remaining tests that will provide the last major pieces of non-medical information for the company to complete the IND package that it will submit to the U.S. Food and Drug Administration (FDA) for its planned Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC) using its signature technology, Cell-in-a-Box together with the cancer prodrug ifosfamide, at trial sites within the United States.

In light of new guidelines coming down from the FDA on conducting clinical trials and several biotechnology companies already pausing their clinical trials during this global COVID-19 pandemic, in addition to needing some clarification on two additional tests that were addressed in PharmaCyte’s recent Quarterly Report on Form 10-Q (10-Q), we talked to the Company’s Chief Executive Officer (CEO), Kenneth L. Waggoner, to gain a better understanding of how COVID-19 may be affecting the company’s work to complete its IND.

Question 1: First and foremost, we’d like you to address the two tests that were discussed in PharmaCyte’s recently filed 10-Q – the Stability Study and the Container Closure Integrity (CCI) test.  What are these?

PharmaCyte CEO: “The Stability Study is a study designed to determine whether the capsules generated from the manufacturing run we will be using in our planned Phase 2b clinical trial remain intact and functional after being frozen at approximately -80°C for specified periods during a 24-month time span and then thawed for a total period of 24 months.  During this period, there are set measuring points, such as month 0, 3, 6, 9, 12, 18 and 24 months.  The parameters being measured at each time point are cell identity, purity, viability, potency and sterility. 

“We have elected to measure sterility by using a CCI test on a syringe containing 300 encapsulated cells.  So, this too is a 24-month test in total.  This test essentially measures whether, over time, the frozen syringes full of our encapsulated cells remain intact.  We will be using High Voltage Leak Detection to determine this.” 

Question 2: You mentioned the duration of both of these tests being 2 years, which naturally begs the question, will you have to complete the entire study/test before you can submit the IND?  If not, how much data is needed from the Stability Study to complete the IND package that you’ll submit to the FDA?  And how much data is needed from the CCI test?