LAGUNA HILLS, Calif., Sept. 15, 2016 (GLOBE NEWSWIRE) — 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®, today addressed shareholders on the development of PharmaCyte’s therapy for advanced pancreatic cancer.
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.”
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing 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. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. 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 comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as an “artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “plan” and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations: PharmaCyte Biotech, Inc. Investor Relations Department Telephone: 917.595.2856 Email: [email protected]
