On December 11, 2019 PharmaCyte Biotech (OTCQB: PMCB) reported that it 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 (Press release, PharmaCyte Biotech, DEC 11, 2019, View Source [SID1234552264]).

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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: View Source