PharmaCyte Biotech Set to Reach Three Major Milestones in 2020
NEW YORK, NY, Jan. 06, 2020 (GLOBE NEWSWIRE) -- PharmaCyte Biotech’s (OTCQB: PMCB) shareholders should expect 2020 to be the year that ushers in a host of much-anticipated milestones. This year the company’s therapy for locally advanced, inoperable pancreatic cancer (LAPC) should finally start to realize a number of key milestones that are both vital to the development of PharmaCyte’s leading product candidate and essential to the biotech investor.
There are 3 milestones specifically that shareholders should be mindful of that could generate the kind of price appreciation that biotech investors have come to enjoy in both big and small bio/pharma companies with each of these same expected milestone announcements.
The first of those milestones, which shareholders should be prepared for, is the submission of an Investigational New Drug application (IND) to the U.S. FDA requesting authorization to administer its investigational therapy to humans in a proposed Phase 2b clinical trial.
Following the submission of an IND, even greater anticipation will grow for what could be a momentous milestone and one that would essentially be announced only weeks later. The second of the 3 milestones that shareholders will be eyeing is the FDA’s response to PharmaCyte’s request to begin a clinical trial. After submission, the FDA will notify PharmaCyte of the date it receives the application through an IND acknowledgment letter, and it is that date that starts the clock on the FDA’s 30-day response time.
An IND application may go into effect:
-- 30 days after the FDA receives the application, unless the FDA notifies PharmaCyte that the investigations described in the application are subject to a “clinical hold” while the FDA collects more information; -- or by being notified earlier than the 30 days by the FDA that the clinical investigations described in the IND may begin.
PharmaCyte needs the IND “in effect” so that the company’s investigational new therapy can be shipped to the investigator(s) named in the IND application. An investigator may not administer an investigational new drug/therapy to humans until the IND application goes into effect.
If given the go-ahead by the FDA to proceed with its proposed Phase 2b clinical trial, PharmaCyte will be one of very few OTC microcap companies to have accomplished this major achievement. An approved IND would mean that the small California-based biotech company could begin a list of preparations to start an FDA clinical trial, including naming clinical trial sites and the recruitment of patients for the trial.
With an IND in effect, the suspense among shareholders and the biotech community for the third and undoubtedly the most exciting of the upcoming 2020 milestones would be palpable—the enrollment of the first patient. Approval means that PharmaCyte could embark upon enrolling the first patient into its proposed multi-site, two-armed Phase 2b clinical trial, and enrolling that first patient would represent a colossal milestone for the company and highlight years of hard work to reach the clinic. It is a milestone that is considered big news for any biotechnology or pharmaceutical company and its investors, but for a small biotech company like PharmaCyte, it should be seen as an even greater feat.
A thumbs-up from the FDA means that PharmaCyte would strengthen its hand regarding potential clinical trial funding. The company will instantly have more credibility given it has the FDA’s “blessing” to further its investigations in a clinical trial, and PharmaCyte will only need to pay as each patient is enrolled into the trial. The company will not need to fully fund a clinical trial upon approval, and given the recruitment process for cancer clinical trials, PharmaCyte can easily fund a trial using a “pay-as-you-go” system.
Also, PharmaCyte will only need to fund those patients who will receive the company’s therapy for LAPC, its signature live-cell encapsulation technology, Cell-in-a-Box® plus low doses of the cancer-killing drug ifosfamide. Patients enrolled in the opposite arm will receive an already-approved FDA drug; therefore, each of these patients’ insurance will pay for their treatment in the clinical trial.
2020 should bring into focus an array of milestones for the company, and it should prove to be the year that offers the company’s shareholders plenty of opportunities to build enthusiasm from each milestone announcement to the next expected milestone. Each milestone, from the IND submission to hopefully what will be a positive FDA response to the IND, to the subsequent start of a clinical trial with the enrollment of the first patient, are all important to both the company and to its shareholders because these accomplishments represent very important events in the operation of a biotechnology company and monumental achievements for a biotech operating as a microcap company.
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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