"Cause or Consequence?

Pancreatic cancer and diabetes are locked in a complicated dance, both pathogenetically and temporally. In the setting of a new pancreatic cancer diagnosis, the timing and course of the diabetes can be divided into three main categories:

long-standing diabetes: present for at least 3 years;

new-onset diabetes: variably defined as less than 1-3 years;

rapidly-deteriorating diabetes: sudden worsening of chronic, stable diabetes.

Each situation begs the question, “Which came first, diabetes or pancreatic cancer?” Aside from the fact that both diseases occur in the same organ, there is not a priori reason that one should directly impact the other."

PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

For those who aren't familiar with the clinical trial process and the development of a therapy for pancreatic cancer, why is it important to have an experienced team surrounding PharmaCyte's technology heading into its clinical trial?

Dr. Manuel Hidalgo: “I cannot emphasize enough how important having an experienced team is to conducting any clinical trial, but even more a trial with a new technology like Cell in a Box®. Elements of an experienced team range from proper patient selection to the delivery of the treatment and monitoring safety and efficacy. Each one of these elements, just to name a few, requires careful attention to details, proper documentation and communication. As this is a new technology and is a non-conventional one, these details become even more important. This is like a performance. The sheet music (protocol) is important but the conductor (investigator) and the orchestra (research team) are also critical.”

The Chief Executive Officer of PharmaCyte explained retention of Facet, “After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.

“Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet.”

In the company’s upcoming trial, the comparator arm that PharmaCyte’s pancreatic cancer therapy will be compared to is the combination of the cancer drug 5-fluorouracil (FU) and the compound leucovorin (LV). The necessary and quick decision was made by Dr. Manuel Hidalgo, the Principal Investigator for the upcoming clinical, Dr. Daniel Von Hoff with Translational Drug Development (TD2), the CRO for PharmaCyte’s clinical trial, and Dr. Matthias Löhr, the Chairman of PharmaCyte’s Medical and Scientific Advisory Board.

TD2 has been involved in many clinical trials. What are your early impressions of PharmaCyte's pancreatic cancer therapy?

Dr. Stephen Gately: “New and effective therapies for patients with pancreas cancer are clearly needed. We have reviewed PharmaCyte’s prior human clinical data and are encouraged that this approach may provide clinical benefit for patients with pancreas cancer. TD2 is grateful for the opportunity to work with PharmaCyte’s team on this exciting project.”

PharmaCyte does not plan to publish a date for the filing of its IND. At the current time, it’s extremely difficult for the company to supply a development timeline that will accurately predict when the IND will be filed. It would be irresponsible of the company to release what, at this point, would be a “hopeful” date for filing the IND. This date could change from day-to-day and week-to-week based upon several unforeseen variables – many of which are beyond PharmaCyte’s control. This means that we cannot give an accurate timeline for filing the IND because we too are awaiting a list of items to be completed by others.

“An IND encompasses many things, dealing with the manufacture and characterization of the product candidate, the clinical study design and nonclinical studies. PharmaCyte’s therapy for pancreas cancer has undergone or been part of several studies, so incorporation of that information into the IND is not ‘rate limiting’ or ‘slowing down the progress towards submitting an IND.’ The clinical study design that PharmaCyte agreed to undertake after meeting with the FDA is currently being drafted. This is also not rate limiting. To conduct the clinical trial, PharmaCyte will need to manufacture, test and release a Master Cell Bank, a Working Cell Bank and the encapsulated live cells. This information is also required to be described and documented in detail in the IND. The manufacture of these items is the rate limiting factor involved in submitting the IND.”

“Before the IND is filed, the following items must be available for inclusion:

(a) Documentation of preclinical work done on the cells.
(b) Toxicology studies.
(c) Documentation of preclinical work done on the capsules themselves.
(d) A wide array of CMC (Chemistry, Manufacturing and Controls) documentation that verifies that the final biologic product (the encapsulated cells) has been produced under current Good Manufacturing Practices (cGMP)-compliant conditions.
(e) Labeling for the final investigational biologic product.
(f) Previous evidence of human experience with the pancreas cancer therapy (low-dose ifosfamide plus Cell-in-a-Box® encapsulated genetically modified human cells).
(h) The Investigator’s Brochure.
(i) The Informed Consent Form
(j) The Case Report Form”

PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

For those who aren't familiar with the clinical trial process and the development of a therapy for pancreatic cancer, why is it important to have an experienced team surrounding PharmaCyte's technology heading into its clinical trial?

Dr. Manuel Hidalgo: “I cannot emphasize enough how important having an experienced team is to conducting any clinical trial, but even more a trial with a new technology like Cell in a Box®. Elements of an experienced team range from proper patient selection to the delivery of the treatment and monitoring safety and efficacy. Each one of these elements, just to name a few, requires careful attention to details, proper documentation and communication. As this is a new technology and is a non-conventional one, these details become even more important. This is like a performance. The sheet music (protocol) is important but the conductor (investigator) and the orchestra (research team) are also critical.”

The Chief Executive Officer of PharmaCyte explained retention of Facet, “After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.

“Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet.”

In the company’s upcoming trial, the comparator arm that PharmaCyte’s pancreatic cancer therapy will be compared to is the combination of the cancer drug 5-fluorouracil (FU) and the compound leucovorin (LV). The necessary and quick decision was made by Dr. Manuel Hidalgo, the Principal Investigator for the upcoming clinical, Dr. Daniel Von Hoff with Translational Drug Development (TD2), the CRO for PharmaCyte’s clinical trial, and Dr. Matthias Löhr, the Chairman of PharmaCyte’s Medical and Scientific Advisory Board.

TD2 has been involved in many clinical trials. What are your early impressions of PharmaCyte's pancreatic cancer therapy?

Dr. Stephen Gately: “New and effective therapies for patients with pancreas cancer are clearly needed. We have reviewed PharmaCyte’s prior human clinical data and are encouraged that this approach may provide clinical benefit for patients with pancreas cancer. TD2 is grateful for the opportunity to work with PharmaCyte’s team on this exciting project.”

PharmaCyte does not plan to publish a date for the filing of its IND. At the current time, it’s extremely difficult for the company to supply a development timeline that will accurately predict when the IND will be filed. It would be irresponsible of the company to release what, at this point, would be a “hopeful” date for filing the IND. This date could change from day-to-day and week-to-week based upon several unforeseen variables – many of which are beyond PharmaCyte’s control. This means that we cannot give an accurate timeline for filing the IND because we too are awaiting a list of items to be completed by others.

“An IND encompasses many things, dealing with the manufacture and characterization of the product candidate, the clinical study design and nonclinical studies. PharmaCyte’s therapy for pancreas cancer has undergone or been part of several studies, so incorporation of that information into the IND is not ‘rate limiting’ or ‘slowing down the progress towards submitting an IND.’ The clinical study design that PharmaCyte agreed to undertake after meeting with the FDA is currently being drafted. This is also not rate limiting. To conduct the clinical trial, PharmaCyte will need to manufacture, test and release a Master Cell Bank, a Working Cell Bank and the encapsulated live cells. This information is also required to be described and documented in detail in the IND. The manufacture of these items is the rate limiting factor involved in submitting the IND.”

“Before the IND is filed, the following items must be available for inclusion:

(a) Documentation of preclinical work done on the cells.
(b) Toxicology studies.
(c) Documentation of preclinical work done on the capsules themselves.
(d) A wide array of CMC (Chemistry, Manufacturing and Controls) documentation that verifies that the final biologic product (the encapsulated cells) has been produced under current Good Manufacturing Practices (cGMP)-compliant conditions.
(e) Labeling for the final investigational biologic product.
(f) Previous evidence of human experience with the pancreas cancer therapy (low-dose ifosfamide plus Cell-in-a-Box® encapsulated genetically modified human cells).
(h) The Investigator’s Brochure.
(i) The Informed Consent Form
(j) The Case Report Form”

Annual diagnoses and deaths of pancreatic cancer in China are now beyond the number of cases in the United States. GLOBOCAN 2012 estimates that cases in China account for 19.45% (65727/337872) of all newly diagnosed pancreatic cancer and 19.27% (63662/330391) of all deaths from pancreatic cancer worldwide.

One in three of world’s adults with diabetes is in China, WHO reports.

Prevalence of chronic disease among Chinese has risen more than ninefold in a generation, far faster than in rest of world, thanks to unhealthy lifestyles, population growth and ageing

China will compel Saudi Arabia to trade oil in the Chinese yuan, posing a threat to the U.S. dollar's status as the world's reserve currency. Carl Weinberg, chief economist and managing director at High Frequency Economics, told CNBC that Beijing stands to become the most dominant global player in oil demand since China usurped the U.S. as the "biggest oil importer on the planet.":

Saudi Arabia has "to pay attention to this because even as much as one or two years from now, Chinese demand will dwarf U.S. demand," Weinberg said.

"I believe that yuan pricing of oil is coming and as soon as the Saudis move to accept it — as the Chinese will compel them to do — then the rest of the oil market will move along with them."

Chinese e-commerce giant Alibaba is on track to overtake U.S. rival Amazon as the world's top cloud computing services firm, according to the Alibaba-owned South China Morning Post. Simon Hu, president of Alibaba Cloud, told the Hong Kong daily that China's vast domestic market and the Chinese government’s “Belt and Road Initiative” gives the company its confidence:

“We have taken on Amazon on all fronts as our benchmark over past three years. Some of our products have already exceeded theirs,” Hu told the South China Morning Post on the sidelines of the Alibaba Computing Conference in the Chinese city of Hangzhou, where the company is based.

“While market expansion needs to be step by step, the technical capabilities of Alibaba Cloud are as good as Amazon’s AWS,” said Hu. He had vowed in 2015 to “match or surpass Amazon in four years” in terms of customers, technology and worldwide scale.

Cancer is currently one of the most important public health problems in the world. Pancreatic cancer is a fatal disease with poor prognosis. As in most other countries, the health burden of pancreatic cancer in China is increasing, with annual mortality rates almost equal to incidence rates. The increasing trend of pancreatic cancer incidence is more significant in the rural areas than in the urban areas. Annual diagnoses and deaths of pancreatic cancer in China are now beyond the number of cases in the United States. GLOBOCAN 2012 estimates that cases in China account for 19.45% (65727/337872) of all newly diagnosed pancreatic cancer and 19.27% (63662/330391) of all deaths from pancreatic cancer worldwide. The population’s growing socioeconomic status contributes to the rapid increase of China’s proportional contribution to global rates. Here, we present an overview of control programs for pancreatic cancer in China focusing on prevention, early diagnosis and treatment. In addition, we describe key epidemiological, demographic, and socioeconomic differences between China and developed countries. Facts including no nationwide screening program for pancreatic cancer, delay in early detection resulting in a late stage at presentation, lack of awareness of pancreatic cancer in the Chinese population, and low investment compared with other cancer types by government have led to backwardness in China’s pancreatic cancer diagnosis and treatment. Finally, we suggest measures to improve health outcomes of pancreatic cancer patients in China.