NEW YORK, NY – 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.”
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: https://www.PharmaCyte.com/Cancer
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 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 cell encapsulation 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. Until the FDA allows us to commence the clinical trial described in our IND involving LPAC, we are not spending any further resources developing this program.