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.
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with press releases, research reports, corporate videos, radio-style CEO interviews and feature news articles.
This article was written based upon publicly available information. Stock Market Media Group may, from time to time, include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB’s filings and disclosures. We also recommend, as a general rule, that before investing in any securities, you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks. We are not a registered broker, dealer, analyst, or advisor. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications about PMCB are not a recommendation to buy or sell a security.
Stock Market Media Group and its management may benefit from any increase in the share price of the profiled companies and hold the right to sell the shares bought at any given time including shortly after the release of the company’s profile. Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment. Under the Securities Act of 1933, Section 17(b), Stock Market Media Group discloses that it expects to be remunerated fifteen thousand dollars monthly from September 2019 to September 2020, paid for by a third party via bank wire, to produce content related to PharmaCyte. This article is the opinion of Stock Market Media Group and was written based upon publicly available information and interviews conducted by SMMG.
Stock Market Media Group does not own any shares in PharmaCyte and never accepts compensation in free-trading shares for its marketing services of the company being profiled, however third parties that might have compensated Stock Market Media Group may hold free-trading shares of the company being profiled and could very well be selling, holding or buying shares of the company’s stock at the same time the content is being disseminated to potential investors; this should be viewed as a definite conflict of interest and as such, the reader should take this into consideration.
If Stock Market Media Group ever accepts compensation in the form of free trading shares of the company being profiled and decides to sell these shares into the public market at any time before, during, or after the release of the company’s profile, our disclaimer will be updated accordingly reflecting the current position of those free trading shares received as compensation for our services.
For more information: www.stockmarketmediagroup.com
Contact: