NEW YORK, NY, Oct. 16, 2019 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has now moved one step closer to submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to request a clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) in the United States.  The company has successfully completed the first of two manufacturing runs to produce the clinical trial product (Cell-in-a-Box® capsules) it needs for its upcoming Phase 2b clinical trial in LAPC. 

Kenneth L. Waggoner, PharmaCyte’s Chief Executive Officer, said that the completion of the first manufacturing run “is a major milestone” towards the completion of the IND.

A few other key events will play themselves out in the weeks to come—all leading to the submission of the IND.  The first of which has already begun.  PharmaCyte stated this week that the second of two staggered and back-to-back manufacturing runs is already underway, and that the cells from the company’s Master Cell Bank (MCB) are growing well in this second run and will be encapsulated within the next week or two.

A successful second run should be regarded as an even greater milestone and extremely good news for the company and its shareholders as it will represent the conclusion of all necessary manufacturing runs on the way to submitting an IND.  cGMP Validation is the company that will take responsibility for PharmaCyte’s clinical trial product coming into the United States and being used in human patients, so two successful manufacturing runs undoubtedly gives cGMP Validation the comfort level it needs to take on this responsibility.

Waggoner said of the second manufacturing run, “Our cGMP expert has recommended that a second manufacturing run be done because, by doing so, we can firmly validate to the FDA that our manufacturing process is both reproducible and robust. Also, additional information on duplicate manufacturing runs may be beneficial to our cGMP expert, who will also serve as our ‘Release Agent’ so that our clinical trial product can be used in human patients in the U.S. in a clinical trial.”

Validating that the company’s manufacturing process is both “reproducible and robust” to the FDA is significant today and well into the future for PharmaCyte, according to the company’s CEO.

“Although we have been advised that the IND for a Phase 2 clinical trial doesn’t require information related to successful duplicate manufacturing runs, it’s important for us to take the extra time to complete the second manufacturing run because the manufactured product is not only the ‘centerpiece’ of our planned clinical trial in LAPC, but it will also likely play a similar role in the treatment of other forms of cancer.”

The most important event left to complete outside of the final manufacturing run is “release testing” of the clinical trial product.  PharmaCyte said that a representative sample of frozen syringes from the first successful manufacturing run, which are filled with 300 Cell-in-a-Box® capsules each, are in the process of being shipped to external testing labs for the release testing that is required by the FDA. 

The data that those tests will produce are all that remains for the company to complete the IND and then submit it to the FDA.

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 was remunerated fifteen thousand dollars 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.

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:

Stock Market Media Group

info@stockmarketmediagroup.com