NEW YORK, NY, Dec. 11, 2019 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has a clinical trial product, a clinical trial protocol, including a clinical trial design, a Principal Investigator, and the company is ready to present its treatment for locally advanced, inoperable pancreatic cancer (LAPC) to the U.S. FDA in an effort to secure approval to begin a Phase 2b clinical trial in LAPC.  

LAPC is a hard-to-treat disease that leaves patients with very little hope after first-line therapies, Abraxane plus gemcitabine or FOLFIRINOX, no longer offer any benefit to this patient population.  The company’s Chief Operating Officer, Dr. Gerald W. Crabtree, said of this group of patients, “Here we have a cadre of patients that are virtually untreatable.  They respond to a certain degree to first-line treatment and then can no longer respond, and there they sit with very little option for further response.”

However, hope, in the form of a unique live-cell encapsulation technology, could very well be on the way for patients who are stricken with LAPC if the FDA approves PharmaCyte’s Investigational New Drug application (IND).  Pancreatic cancer is usually only controllable through removal by surgery and only if found before it has spread to other parts of the body or other organs.  PharmaCyte’s treatment, which consists of its signature live-cell encapsulation technology, Cell-in-a-Box®, plus low doses of the chemotherapy drug ifosfamide, has already proven in earlier Phase 1 and Phase 2 clinical trials that it can be effective in doing just that—shrinking tumors to the point that they become operable. 

Commenting on those earlier trials, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “What’s unique about our therapy is looking back at the earlier clinical trials, patients that had stage 4 metastatic pancreatic cancer had their tumors go from inoperable to operable.”

PharmaCyte plans to conduct a Phase 2b clinical trial with a treatment that uses genetically engineered cells to treat cancer.  Those cells have been engineered to produce an enzyme, which is normally produced in the patient’s liver, that will convert ifosfamide from its inactive form to its active form.  Essentially what patients with LAPC can expect from PharmaCyte’s treatment is that it diverts the conversion of ifosfamide from the patient’s liver, where normal conversion takes place, to the 300 Cell-in-a-Box® capsules, which contain a total of about 6.6 million live cells located in the blood supply to the pancreas and whose job it is to “wake up” the non-active drug right at the site of a patient’s tumor.

PharmaCyte’s Chief Scientific Officer, Prof. Dr. Walter H. Günzburg, says, “We’ll be placing those 300 capsules angiographically into the pancreas just upstream of the tumor.  The idea being that blood will then come in, bring the non-active prodrug, ifosfamide, to the capsules, and the drug will then be converted inside the capsules to its active form and the prodrug will stream directly into the tumor, so this gives the highest possible concentration of the tumor killing drug actually at the site of the tumor.”

For patients suffering from LAPC, this treatment is great news because a much smaller dose of the cancer-killing drug means that it’s a targeted chemotherapy with little to no side effects.  Dr. Günzburg added, “We’re converting the drug at the site of the tumor so that patients will experience a very high anti-tumor kill and a very low systemic toxicity.” 

Dr. Crabtree, who was part of the team at Bristol-Myers Squibb that brought the highly successful cancer drug Taxol® (paclitaxel) to market, said, “I’ve been in the cancer business for 50 years, and I’ve been involved in developing a lot of decent drugs—some very good drugs—and worked with some very good people, and this technology to me has been a revelation.  It’s completely different from anything else that I have ever experienced, and to me, it presents an absolute new way to treat a very difficult to treat tumor.

“Here we have a chance to have very good results with minimal side effects.  In the cancer business, you can’t ask for more than that.”

The pancreatic cancer community should be anxiously awaiting PharmaCyte’s submission of its IND to the FDA and the subsequent days following as everyone waits patiently for the FDA to  approve what could be a landmark clinical trial in LAPC.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. 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 encapsulating a human 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 developing the use of genetically modified liver cells and stem cells, as well beta islet cells, to treat diabetes. 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 a “bio-artificial pancreas” for purposes of insulin production.

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