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|Day's Range||0.0281 - 0.0320|
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PharmaCyte Biotech (PMCB) continues to work with consultants to prepare its Investigational New Drug application (IND). At the same time, PharmaCyte is reportedly completing the remaining tests that will provide the last major pieces of non-medical information for the company to complete the IND package that it will submit to the U.S. Food and Drug Administration (FDA) for its planned Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC) using its signature technology, Cell-in-a-Box® together with the cancer prodrug ifosfamide, at trial sites within the United States. In light of new guidelines coming down from the FDA on conducting clinical trials and several biotechnology companies already pausing their clinical trials during this global COVID-19 pandemic, in addition to needing some clarification on two additional tests that were addressed in PharmaCyte’s recent Quarterly Report on Form 10-Q (10-Q), we talked to the Company’s Chief Executive Officer (CEO), Kenneth L. Waggoner, to gain a better understanding of how COVID-19 may be affecting the company’s work to complete its IND.
PharmaCyte Biotech receives Certificates of Analysis and batch records for the manufacture of its clinical trial product to treat pancreatic cancer.
PCG Media covers the value that PharmaCyte's Cell-in-a-Box® technology can bring to the pancreatic cancer market. Future indications expected to target diabetes and cannabinoid therapy. New York, New York--(Newsfile Corp. - February 11, 2020) - Investors searching for emerging leaders in the cellular therapeutics sector may find interest in PharmaCyte Biotech, a company committed to its development of cancer and diabetes treatments that have the potential to revolutionize the current standard of care in treating ...
Soulstring Media Group covers how this emerging biotech can become a potential leader in treating pancreatic cancer and diabetes with its Cell-in-a-Box(R) technology Miami Beach, Florida--(Newsfile Corp. - February 6, 2020) - For investors interested in finding undervalued opportunity, PharmaCyte Biotech may be a stock to watch as the company positions itself to potentially create enormous shareholder from its ongoing development of cellular therapies targeting cancer and diabetes. Just last week, PharmaCyte (OTCQB: PMCB) ...
PharmaCyte Biotech (PMCB) is about to embark upon a planned U.S. FDA Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC) at trial sites all over the United States, and with that journey comes the need to keep its signature technology, Cell-in-a-Box®, protected should it one day receive marketing approval from drug regulatory agencies in the U.S. and Europe. PharmaCyte’s Cell-in-a-Box® technology for the treatment of pancreatic cancer is certainly protected well into the future if/when it does receive the coveted marketing approval it’s striving for upon the completion of clinical trials. Currently, PharmaCyte is revamping its provisional patent application and its strategy related to full patent protection.
PharmaCyte Biotech (PMCB) announced that its clinical trial product, which will be employed during the company’s upcoming Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC), has passed each of the U.S. Food and Drug Administration’s (FDA) required “release tests” for safety and functionality. With a clinical trial product that has proven to be safe and functional, PharmaCyte is now “on-the-clock” for its submission of an Investigational New Drug application or “IND” package to the U.S. FDA requesting a Phase 2b clinical trial in LAPC at trial sites throughout the United States.
This month the American Cancer Society announced that for the first time ever, the 5-year survival rate for pancreatic cancer has reached double digits. While this is certainly good news, the increase in the 5-year survival rate was up just 1% to 10%, and there is still an unmet medical need for patients with locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte Biotech (PMCB) continues to move toward a planned Phase 2b clinical trial in LAPC to address those patients who no longer see any benefit after being treated for 4-6 months with one of two first-line therapies for the disease.
PharmaCyte Biotech’s (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.
PharmaCyte Biotech (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.
PharmaCyte Biotech (PMCB) has reduced a long list of FDA-required items to just one last important component—release testing—before it can submit an Investigational New Drug application (IND) to the U.S. FDA. PharmaCyte’s IND application will request permission from the FDA to conduct a Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). With the FDA’s approval to begin a clinical trial, PharmaCyte’s opportunities for funding improve dramatically.
Clinical trials are essential for the development of new treatments, and PharmaCyte will enter this upcoming trial with two essential goals in mind—the future of its pancreatic cancer treatment and the future of its technology. First, successfully shrinking tumors would address a real unmet medical need for a group of patients that no longer realizes any benefit from either of the two first-line therapies. Second, and of equal importance for the small California-based biotech, will be to utilize the company’s first-ever clinical trial to validate or prove that its signature live-cell encapsulation technology, Cell-in-a-Box®, is both effective and safe to use in humans. When asked about the importance of validating its technology in a clinical trial setting in relation to the company’s future, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “PharmaCyte is on the precipice of completely changing the paradigm for how diseases are treated in the future.
NEW YORK, NY, Oct. 16, 2019 -- PharmaCyte Biotech (OTCQB: PMCB) has now moved one step closer to submitting an Investigational New Drug application (IND) to the U.S. Food and.
During a conference call with shareholders late last week, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, told shareholders that the company is in the final days of the first of two back-to-back, staggered manufacturing runs, and that he is “very encouraged” by the reports he’s getting from Austrianova—the company conducting the manufacturing runs to produce the Cell-in-a-Box® capsules for PharmaCyte’s upcoming clinical trial. Once this first manufacturing run is completed successfully, the final stage in the process—testing those capsules and the live cells inside that make up the Cell-in-a-Box® technology—can begin. The capsules will be placed into syringes and then those syringes will be frozen and stored in a freezer at Austrianova’s manufacturing facility in Thailand. Soon thereafter, a representative sample of the Cell-in-a-Box® syringes will be thawed and a series of tests (release testing) will begin. These FDA-required tests are necessary for PharmaCyte to be able to use its product in human beings in a clinical trial.