PharmaCyte Biotech (OTCQB: PMCB) has reached the proverbial “home stretch” regarding its efforts to submit an Investigational New Drug Application (IND) to the U.S. FDA. It’s an IND that has been eagerly anticipated by the company’s shareholders since PharmaCyte met with the FDA in early 2017, and it would lay out PharmaCyte’s planned Phase 2b clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC.
The key to submitting the IND is and always has been satisfying regulatory requirements. In short, PharmaCyte must generate the necessary data that the FDA requires for any treatment—but especially a treatment that is deemed a “biologic” by the FDA and comprised of living cells that would be placed inside a human’s body.
PharmaCyte just announced that it has completed and passed 29 different tests from its Master Cell Bank (MCB), which is made up of cells that will be used in its planned clinical trial in patients with LAPC. The successful completion of these tests is the final hurdle before encapsulation and testing of the encapsulated cells can begin at Austrianova.
Vials of cells from the MCB have already been supplied to the company’s partner, Austrianova, for encapsulation. Austrianova will now be charged with completing the encapsulation process using PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box®, to create the thousands of capsules that will be necessary to conduct its planned clinical trial. Each capsule will contain 10,000 live cells, and then each syringe will be filled with 300 capsules—making up the finished product that will be sent to clinical trial sites.
The encapsulation process will be followed by a battery of tests that will generate the necessary data to satisfy regulatory requirements and should complete what has been a long, meticulous process and allow PharmaCyte to finally submit it’s IND to the FDA.
In addition to the 29 successful tests that PharmaCyte announced last week, the company has stated that a number of additional tests have also been a success (See www.PharmaCyte.com/news). This is all very good news for shareholders who have been clamoring for the start of a clinical trial, and it should bode well for a company that is trying to win the FDA’s approval when it does submit its IND.
PharmaCyte’s goal of starting a Phase 2b clinical trial to meet an unmet medical need in the treatment of patients with LAPC is a remarkable milestone for such a small company, and because their first ever trip inside the clinic involves presenting the FDA with a biologic treatment, the sheer complexity of this journey explains why the process has been so time consuming. PharmaCyte’s treatment for LAPC utilizes genetically engineered live human cells that produce a particularly potent cytochrome P450 enzyme that is able to activate the chemotherapy prodrug ifosfamide.
As previously mentioned, these cells are encapsulated using the Cell-in-a-Box® technology, and the tiny, pinhead-sized capsules are implanted near the cancerous tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor.
PharmaCyte’s treatment is not a single molecule drug. It’s not a drug at all actually. And because the treatment is made up of live human cells that are responsible for activating an already FDA-approved chemotherapy drug, the FDA expects every single cell to act exactly the same way, every single time, in every single test that PharmaCyte is required to conduct.
The FDA simply wants to know that the capsules and the cells that live inside them will remain exactly the same at all times when they are eventually placed inside the human body. And unfortunately there is no short cut when it comes to satisfying regulatory requirements.
The unmet medical need that PharmaCyte expects to address in its clinical trial is for those patients who no longer see any benefit from using the preferred standard of care, Abraxane® combined with gemcitabine, or FOLFIRINOX, another combination chemotherapy that is increasingly being used in the U.S. as the preferred standard of care. These patients must have tumors that no longer respond to these combination chemotherapies after they’ve been on the treatment for a period of between 4 and 6 months.
The good news for PharmaCyte’s patient shareholders is that the company has reached the “end of the line” in what has been a very long process. But, when it comes to the FDA and success in a clinical trial—especially for a small company like PharmaCyte—there is only one true shot at getting it right.
Stock Market Media Group will be interviewing PharmaCyte’s CEO, Kenneth L. Waggoner, and its Chief Scientific Officer, Prof. Dr. Walter H. Günzburg, to discuss the IND, encapsulation, testing, preparations for the upcoming planned clinical trial, among other topics. The radio-style interview will be released and announced publicly via a press release within the next 2 weeks.
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