Disruptor in a $4.2 Billion Pancreatic Cancer Market!

PMCB biotech stock

Pharmacyte Biotech (Stock:PMCB)

 

·       Disruptor in a $4.2 billion pancreatic cancer market with a credible solution

·       Continues to move toward a planned Phase 2b clinical trial in LAPC to address patients who no longer see any benefit after being treated for 4-6 months with one of two first-line therapies for the disease.

·       Its therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form.

·       Successfully completed the crucial pyrogenicity testing that is required by the U.S. Food and Drug Administration (FDA) of the encapsulation material used to manufacture PharmaCyte’s Cell-in-a-Box® capsules 

·       Just entered into a license agreement for CV-19 diagnostics tests

 

Cancer facts are still alarming – and in dire need of urgent attention.

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.

However, big changes may be on the way.

 

In fact, PharmaCyte Biotech (Stock:PMCB) is hoping to change things for the better – and give patients a second chance on life.

 

By using its cellular targeted-chemotherapy to make inoperable tumors—operable—as pancreatic cancer is usually only controllable through removal by surgery and only if found before it has spread to other parts of the body and other organs. 

Currently, the company is in the final stages in its efforts to submit an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA).  Once the IND is submitted, PharmaCyte will hope to obtain permission from the FDA to begin its planned clinical trial.

 

Symbol: PMCB

Company: PharmaCyte Biotech Inc.

Latest News: https://pharmacyte.com/news/

Company Website: https://pharmacyte.com

Who is Pharmacyte Biotech (Stock:PMCB)

Pharmacyte Biotech Inc. (Stock:PMCB) is a disruptor in a $4.2 billion pancreatic cancer market with a credible solution. 

PMCB Disruptor

Helping to meet an unmet medical need for patients with locally advanced, inoperable pancreatic cancer (LAPC), 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®.”

 

Its therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. Its therapy for Type 1 diabetes and in-sulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release in-sulin in response to the levels of blood sugar in the human body.


At the moment, PharmaCyte Biotech 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.

Breaking News PMCB 5/4/2020: Completes Medical Manual for IND Filing

FULL PRESS

Pharmacyte Biotech: Recent Catalysts

Rapid Advancement for a 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.

Furthermore, as PharmaCyte already has a well-established foundation allowing for rapid development of technology that can meet critical unmet medical needs, the timeliness of the product has drawn attention from physicians and hopeful patients. In this case, the encapsulating of genetically engineered human cells have demonstrated the unique capability to convert inactive chemotherapy drugs into active “cancer-killing” armies.

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 has shown through case studies that its technology can take a chemotherapy drug, such as ifosfamide, and permit it to move through the pores in encapsulated cells and trigger the live cells to act as a “bio-artificial liver” that can activate the chemotherapy drug at the site of the cancer.

 

Successfully Completed Pyrogenicity Testing: PharmaCyte successfully completed the crucial pyrogenicity testing that is required by the U.S. Food and Drug Administration (FDA) of the encapsulation material used to manufacture PharmaCyte’s Cell-in-a-Box® capsules. The capsules, which house live human cells, passed the test and are deemed non-pyrogenic.

 

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed pyrogenicity testing, “While we never doubted that the capsules would be pyrogen free, we are very pleased that this vital FDA-required study has been successfully completed. We continue to remain centrally focused on submitting an Investigational New Drug application (IND) to the FDA.”

 

“To that end, our team works every single day to complete the necessary items that will allow PharmaCyte to submit an IND for its planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer. Meanwhile, as each test and item are completed, our team of experts and consultants is diligently compiling the data from these completed items and creating our IND package in real time.”

 

All medical products that are delivered to the body have to be pyrogen free. Pyrogens are fever inducing substances that can cause side effects and influenza-like symptoms. Substances produced by bacteria (endotoxins) can be pyrogens, but other nonbacterial substances can be pyrogenic too.

 

The Cell-in-a-Box encapsulation procedure uses starting materials that have been tested and shown to be endotoxin free. However, the encapsulation process and machinery used for production of PharmaCyte’s CypCaps might potentially introduce nonbacterial pyrogens into the material used to encapsulate the human cells.

 

The United States Pharmacopeia1 as well as the FDA2 require that advanced therapeutic medicinal products like CypCaps have to be tested for pyrogens.

 

Entered into License Agreement for CV-19 Diagnostics Kits:  Pharmacyte is seizing the opportunity to offer testing kits for the coronavirus, partnering with Hai Kang Life Corporation  to deliver a testing solution that could offer a much more accurate test than is currently being used globally.

 

The first step is to apply to the U.S. FDA for Emergency Use Authorization and prove that the test manufactured by Hai Kang works for the purposes of detecting the SARS-CoV-2 virus.  It’s a process that can take as little as a few weeks. 

 

“We will be able to help with the shortage of accurate diagnostic kits.  If we obtain approval, it should provide an immediate and material stream of revenue to us to help fund our other endeavors, while at the same time, helping a world in dire need for the product we are trying to get approved for use in the clinic,” noted the company.

 

Better, according to Hai Kang’s founder and current chairman, Professor Albert Cheung-Hoi Yu, Ph.D., this test is 10 times more sensitive than the other tests being used to detect the virus. 

 

Hai Kang says that its testing kit, on the other hand, eliminates the false negatives by improving upon the RT-PCR tests with its own Enhanced Fluorescent Real-Time Reverse Transcription-Polymerase Chain Reaction (ERT-PCR) tests, which are so sensitive that they only require a minimum sample to detect the virus.  The company states that the RT-PCR detection technology being used around the world must use 50 to 100 viral genes for testing, while Hai Kang’s ERT-PCR test only needs to use one viral gene to detect the virus.

In Conclusion

There are plenty of reasons to pay close attention to Pharmacyte Biotech.

For one, Pharmacyte Biotech Inc. (OTC: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 (LAPC), 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®.”

In fact, 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 (LAPC).


Two, it just partnered with Hai Kang Life Corporation  to deliver a testing solution that could offer a much more accurate test than is currently being used globally.  In fact, the test is reportedly 10 times more sensitive than the other tests being used to detect the virus. 

“We will be able to help with the shortage of accurate diagnostic kits.  If we obtain approval, it should provide an immediate and material stream of revenue to us to help fund our other endeavors, while at the same time, helping a world in dire need for the product we are trying to get approved for use in the clinic,” noted the company.

Key Points

·       Disruptor in a $4.2 billion pancreatic cancer market with a credible solution

·       Continues to move toward a planned Phase 2b clinical trial in LAPC to address patients who no longer see any benefit after being treated for 4-6 months with one of two first-line therapies for the disease.

·       Its therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form.

·       Sccessfully completed the crucial pyrogenicity testing that is required by the U.S. Food and Drug Administration (FDA) of the encapsulation material used to manufacture PharmaCyte’s Cell-in-a-Box® capsules 

·       Just entered into a license agreement for CV-19 diagnostics tests


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