Update from the company Released Today: PharmaCyte Biotech Successfully Accelerates Development of Container Closure Integrity Test for Pancreatic Cancer Clinical Trial Product.
Typically, pancreatic cancer has been notoriously aggressive, with a five-year survival rate of less than 10%. However, a potential solution to the alarming issue is creating a $4.2 billion market opportunity with Pharmacyte Biotech (Stock:PMCB) a prime beneficiary.
At the moment, pancreatic cancer, the third leading cause of cancer-related deaths will impact an estimated 57,600 Americans this year. Approximately, 47,050 are expected to die from it.
While the American Cancer Society has said the five-year survival rate for pancreatic cancer has reached double digits, it only increased by 1% to 10%. In addition, there’s still an unmet medical need for patients with locally advanced, inoperable pancreatic cancer (LAPC).
Currently, patients, who are diagnosed with late-stage pancreatic cancer, are offered one of two first-line chemotherapy treatments. Abraxane plus gemcitabine or a 4-drug combination therapy called FOLFIRINOX. But, once these treatments no longer offer any benefit to patients, sadly, their options for any meaningful effective treatment have run out.
Big changes may be on the way thanks to Pharmacyte Biotech (Stock: PMCB).
Just recently, the company announced final major study for its Investigational New Drug (IND) submission just began using its live-cell encapsulation device, Cell-in-a-Box.
The study, referred to as the “Stability Study” is a rolling two-year study to demonstrate how the frozen clinical trial product manufactured by Austrianova Singapore (Austrianova) for patients with locally advanced, inoperable, pancreatic cancer (LAPC) performs over time after being frozen for certain periods of time and then thawed and tested for functionality. While the study will continue for 2 years, the FDA requires 3 months of stability data to be included in the IND for its submission.
The tests for the Stability Study started approximately 3 months (the first time point in the 2-year study) from the issuance of the Certificate of Analysis for the second successful manufacturing run and will continue for 24 months. Data from the balance of the Stability Study will be provided to the FDA as the data becomes available.
Pharmacyte Biotech is Rapidly Advancing Towards a Much-Needed Solution
PharmaCyte is adopting a novel approach in providing treatments against diseases like cancer and diabetes. And, the technology powering Cell-in-a-Box®, the company’s cellulose-based live-cell encapsulation technology, is a powerful asset behind this California-based biotechnological company. More than just powerful, though, the technology may offer the capability of developing into a multi-purpose platform of focused treatments that can target multi-million dollar health market opportunities.
With this in mind, looking only at the updates of the clinically-indicative effectiveness against inoperable pancreatic cancer may not be doing justice to the full potential offered by the Cell-in-a-Box® technology.
In fact, the functionality of its live-cell encapsulation technology can work to generate long-term value through its ability to be modified and integrated to treat multiple diseases, diabetes, and other illnesses caused by cell mutation. Acknowledging these additional applications made possible by the Cell-in-a-Box® technology makes this product all the more valuable for long-term company growth.
PharmaCyte has clinically demonstrated that these implanted encapsulated cells can enter the blood supply and release an effective combination of cancer-fighting medications. Additionally, the cancer-killing potential of the drug may be strengthened as the delivery through the patient’s circulatory system near the tumor site allows for greater effectiveness.
PharmaCyte Biotech Conducting Manufacturing Facility Nearing cGMP Compliance
The company just announced that cGMP Validation, the company’s GMP consultant, is conducting its final audit of the manufacturing facility in Thailand where PharmaCyte’s clinical trial product was produced by PharmaCyte’s partner, Austrianova Singapore (Austrianova).
When the audit is completed, cGMP Validation will give PharmaCyte approval to import the clinical trial product to the company’s supply chain vendor in the United States who will store the product at -80C until it is needed.
In addition, Austrianova and cGMP Validation have now completed their work together to achieve what has been deemed cGMP compliant batch records for the two manufacturing runs successfully produced by Austrianova.
Both worked closely together to revise the batch records that were generated during the two manufacturing runs that produced PharmaCyte’s clinical trial product for its planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We continue to work through a checklist of items that are necessary to submit an acceptable Investigational New Drug application (IND) to the FDA. The work that cGMP Validation and Austrianova are currently performing to audit the manufacturing facility in Thailand and the work they have completed working together to make certain the batch records meet the cGMP requirements for manufacturing a clinical trial product was and continues to be incredibly detailed and must continue to follow strict FDA guidelines.
Why Consider Pharmacyte Biotech Today
There are plenty of reasons to pay close attention to Pharmacyte Biotech.
For one, Pharmacyte Biotech Inc. (Stock:PMCB) is a disruptor in a $4.2 billion pancreatic cancer market with a credible solution. Helping to meet an unmet medical need for patients with locally advanced, inoperable pancreatic cancer, the biotechnology company is developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.”
Two, its Cell-in-a-Box technology may be a game changer in treating pancreatic cancer, with a treatment for those with locally advanced, inoperable pancreatic cancer. And three, Pharmacyte Biotech is quickly moving toward its Investigational New Drug (IND) application with the U.S. FDA.
Three, it just announced final major study for its Investigational New Drug (IND) submission just began using its live-cell encapsulation device, Cell-in-a-Box.
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