PharmaCyte Biotech, Inc. (OTCQB: PMCB) is closing in on what will be a landmark event in this small company’s history—a clinical trial in the United States under the watchful eye of the most powerful drug regulatory agency in the world, the U.S. Food and Drug Administration (FDA). It would be the company’s first clinical trial ever and could serve as the event that changes the way solid cancerous tumors are treated, while at the same time, proving that PharmaCyte has what is considered the “Holy Grail” for diabetes—an encapsulation technology that can live inside the human body and protect the cells inside from the body’s own immune response.
PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box®, is a one-of-a-kind cell encapsulation technology, and its planned clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC, could very well attract a lot of attention from companies, organizations and investors in both the cancer and diabetes spaces.
What makes this cell encapsulation different than others that have been tried? For the treatment of cancer, PharmaCyte’s Cell-in-a-Box® technology is made up of tiny pinhead-sized porous capsules that contain about 10,000 live cells. Unlike many other encapsulation materials, the Cell-in-a-Box® technology offers the following advantages for developing a therapy that will live inside the human body.
— Capsules are made of bio-inert material and are biocompatible
— Capsules have been proven to be safe, effective, and durable inside the human body
— Capsules do not elicit immune responses or damage surrounding tissues
— Capsules have pores for nutrient and waste transfer
— Pores are too small for immune system cells to enter or encapsulated live cells to leave
Manageable logistics and long shelf life
— Other encapsulation materials – such as alginate – are less robust and stable. The others break down in a relatively short period of time in the body, allowing the immune system cells to destroy the cells inside of the capsules
— None of the others can effectively freeze live cells to ship them to anywhere in the world and then be thawed with approximately 95% viability of the encapsulated live cells
PharmaCyte’s pancreatic cancer candidate is a “targeted chemotherapy” treatment that has proven itself effective and safe to use in past clinical trials. It’s a therapy that has shown little to no treatment-related side effects, and it could significantly reduce tumor size. Chemotherapy with little to no side effects is unheard of in the cancer arena, and, if PharmaCyte is successful in FDA clinical trials, this treatment could truly change the way that patients with solid tumors are treated well into the future.
If given the go-ahead by the FDA to enter a clinical trial after PharmaCyte submits its Investigational New Drug application (IND), it will be the company’s pancreatic cancer treatment that is under the watchful eye of the FDA, but let’s be honest—it is the company’s live-cell encapsulation technology that is truly on trial in the court of public opinion when it comes to future possibilities for Cell-in-a-Box® and its potential applications for solid cancerous tumors and diabetes.
Why would there be so much interest in a “targeted chemotherapy” treatment with little to no treatment-related side effects or in a live-cell encapsulation technology that can survive inside the human body without being attacked by the body’s own immune system cells? Well, sadly it really is all about money. Undoubtedly a better treatment for patients who suffer from LAPC is long overdue; however, developing treatments for other solid cancerous tumors and diabetes are far more lucrative.
Numbers don’t lie and as of 2016, $827-billion are spent annually in the treatment of diabetes worldwide. This is a staggering number, but it certainly sheds some light on why a treatment for diabetes that doesn’t include monitoring glucose levels, diabetics sticking their fingers many times a day, wearing insulin pumps, etc. is being sought by many companies, organizations and universities.
And this is just diabetes. There are many cancers that a therapy like PharmaCyte’s could potentially be developed for as well, including ovarian, liver, breast, and colon.
In a press release earlier this year, PharmaCyte’s CEO stated that the possibility exists that if the data produced in a planned clinical trial from PharmaCyte’s therapy are significantly better than the data from the comparator arm(s), this may allow PharmaCyte to apply to the FDA for accelerated approval. It is this data along with the survivability of the capsules and the cells inside the capsules that many will be waiting to see. Accelerated approval could be accomplished if PharmaCyte applies for and receives approval for either the Breakthrough Therapy designation or the Fast Track designation.
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 as close as possible to the site of the patient’s tumor.
Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at about one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted, and 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.
Meanwhile, PharmaCyte already has a diabetes candidate as well. Its therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating 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 and/or beta islet cells. The encapsulation for this therapy is also done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they function as a “bio-artificial pancreas” for purposes of insulin production. Additionally, PharmaCyte says it plans to explore the encapsulation of beta islet cells as an alternative to using genetically modified human cells.
The path forward is clear, and there really is only one thing left to do. PharmaCyte must get the FDA’s approval to begin a clinical trial for the treatment of LAPC, and then use that trial as an opportunity to prove to its shareholders and to those in both the biotechnology and pharmaceutical sectors that are developing treatments for cancer and diabetes that this one-of-a-kind cell encapsulation technology can dramatically change the way that these two diseases are treated.