On August 3, 2020 PharmaCyte Biotech (OTCQB: PMCB) reported that it 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) (Press release, PharmaCyte Biotech, AUG 3, 2020, View Source [SID1234562712]). 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.
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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."
Of note, a DMF is a prerequisite to securing approval and commercialization and "ensures confidentiality of proprietary information" related to the Active Pharmaceutical Ingredient (API). It is this confidentiality that is sacred to both Austrianova and PharmaCyte and exactly why it’s one of the very last items to be crossed off the lengthy checklist before the IND can be submitted.
Dr. Salmons agrees, "Information on the drug product must be included in the IND and detailed information on, among other things, the manufacture and testing of the drug product, is contained in the DMF. So, in a way, it can be considered the final piece of the puzzle."
In reality, just 2 items remain before PharmaCyte can submit its IND and both will likely be accomplished in the coming days. In a June 23rd press release, PharmaCyte announced a list of tasks that needed to be completed before it could submit its IND to the U.S. FDA. Most of that work was performed by PharmaCyte’s consultants and has been completed.
PharmaCyte’s CEO, commenting on the status of the IND, said, "Virtually all of the IND has been completed. During the last few months, we have completed the Trial Protocol, the Investigator’s Brochure, the Environmental Analysis, the General Investigation Plan, the Introduction Summary, the Nonclinical Overview, the Clinical Overview, the Nonclinical Written and Tabulated Summaries, the Pharmacy Manual, the Study Reports and related information of the prior clinical studies pertinent to the treatment for LAPC, the Regulatory Publishing of the IND and supporting documents, and the Drug Master File. Some of these documents are being updated with new data.
"So, we’re now left with completing the Informed Consent, which is being prepared by our Principal Investigator, Dr. Manuel Hidalgo and his staff, and we need to hire a Chief Medical Officer (CMO) in oncology to represent the company’s interest in the planned clinical trial. Two well-qualified candidates have been interviewed and the selection process is nearly complete. We expect that both the Informed Consent and the hiring of a CMO should be completed over the next week. When this is complete, we plan to file the long-awaited IND."
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source