PharmaCyte Biotech Ready to Submit Investigational New Drug Application to FDA for Clinical Trial in Pancreatic Cancer

NEW YORK, NY, Aug. 03, 2020 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has reached what can only be described as a momentous milestone in its history and what should be considered a remarkable moment for any small biotech—the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA).  This upcoming interaction with the FDA to request a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) is the product of years of meticulous work and dedication to the development of a treatment for the third leading cause of cancer-related deaths in the United States.

Pancreatic cancer is a hard-to-treat disease with only a 9% five-year survival rate, so the recent announcement that PharmaCyte’s partner, Austrianova, has submitted a Drug Master File (DMF) to the FDA is welcomed news because it symbolizes the IND package that we expect will be submitted to the FDA early this month (August) is very near completion. 

PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, said “We’ve reached an exciting milestone at PharmaCyte that has us on the precipice of reaching our long-awaited goal of submitting an IND.  We’re elated to announce that our partner, Austrianova, submitted a DMF with the FDA for the production of our Cell-in-a-Box encapsulated cell product CypCaps.  This DMF is an important and significant event since it is the last prerequisite for the formal FDA application process.  It will support and now facilitate the submission of our IND.”

Dr. Brian Salmons, the CEO and President at Austrianova, said, “The DMF provides all of the confidential and detailed, comprehensive, information covering the production of Cell-in-a-Box encapsulated cell products, including PharmaCyte’s CypCaps product.  

“As you well know, the DMF is an important milestone event that represents a culmination of many years of work on the GMP-production process, the studies that led to the parameters chosen, the materials used in the manufacturing and their specs, processing, packaging, and storing of the Cell-in-a-Box encapsulated cell products, including CypCaps. It also provides detailed information on Austrianova's production facilities in Thailand where the CypCaps product is produced under GMP.”