On September 15, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that they addressed shareholders on the development of PharmaCyte’s therapy for advanced pancreatic cancer today (Press release, PharmaCyte Biotech, SEP 15, 2016, View Source [SID:SID1234515154]).
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The Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner, commented, "We understand that shareholders are frustrated with our current share price; however, the share price doesn’t reflect where PharmaCyte is today. In what has been a relatively short time for a biotech company, we have dramatically moved our Cell-in-a-Box technology forward along the path toward the clinic, we have surrounded our technology with some of the best minds in the industry and we have put together a team that is working diligently every single day to get PharmaCyte in front of the U.S. Food and Drug Administration (FDA) so that we can clear the final hurdles that will allow us to begin our clinical trial in advanced pancreatic cancer. There are numerous moving parts on many fronts. Just because our shareholders aren’t seeing news on a weekly basis, this does not mean there isn’t a flurry of work being done every single day.
"It is important for our shareholders to realize that PharmaCyte’s pancreatic cancer therapy is classified by drug regulatory authorities as a ‘biologic’ rather than a single molecule drug or a New Chemical Entity (NCE). This is because our therapy involves the use of living, genetically altered human cells. The overall development process is much more involved and more complex for a biologic than an NCE. Nevertheless, PharmaCyte’s therapy is moving forward at a realistic pace. Our partner Austrianova will be carrying out an engineering manufacturing ‘run’ in the near future of the production of the capsules that will be used with low dose ifosfamide as our pancreatic cancer therapy. If successful, not only will this run define the specifications of the capsules that will be use to encapsulate the living cells, it will also set the stage for cGMP production of the capsules for our planned clinical trial.
"An example of the different environment that we’re working in is that biologic products – particularly encapsulated living cell products like PharmaCyte’s and unlike most pharmaceutical products which can be simply ‘end-sterilized’ and delivered as sterile products – must be kept alive from the moment the cells are thawed from the frozen research cell bank and then encapsulated until they are implanted in a patient. At all times during these operations our product must be kept free of contamination by bacteria, yeast and fungi. Thus our biologic product is more akin to a live vaccine or to a stem cell therapy. The cell culture medium used to maintain the living cells within the capsules is also an excellent growth medium for all of those previously mentioned undesirable contaminants. Contaminant and other testing of our research cell bank is underway at ViruSure, one of PharmaCyte’s contractors, while Austrianova continues to make steady progress in order to manufacture cGMP clinical trial material that we will need to begin the trial.
"It goes without saying that great care has to be taken at every step to ensure the maintenance of aseptic conditions; this is one reason for carrying the production out in an ‘isolator’ that prevents actual contact between production staff and the product being manufactured. A living cell product also brings with it new regulatory challenges. PharmaCyte has been steadily working through these challenges with a number of regulatory advisors both in the United States and in the United Kingdom. These exciting new "Advanced Medicinal Products" are the future of treatment for serious diseases, and in many ways pioneering companies, like PharmaCyte, are working with the regulators to lay the ground work for tomorrow’s regulatory framework."