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Very nice post, as usual, Bill. Enjoy your hazy, lazy day...
Very well said, Bio.
Great interview with Dr Crabtree. Really good source of information and all you have to do is press play and listen. I learned a lot listening to the interview.
Thanks Pete...
http://www.pharmacytebiotech.com/new-advances-in-diabetes-treatment-insulin-producing-cells-that-could-replace-injections/
PharmaCyte Biotech Creates Faster Path to the Clinic for Company's Diabetes Treatment
NEW YORK, NY--(Marketwired - May 20, 2015) - PharmaCyte Biotech (OTCQB: PMCB) has managed to do something that is rarely done in science -- bring together an international group of leading experts to work on one project. The project that is drawing their interest is PharmaCyte Biotech’s diabetes treatment and getting that treatment into the hands of insulin-dependent patients around the world. These experts have become known collectively as the "International Diabetes Consortium," and if PharmaCyte is to be successful, it will be due, in large part, to the work done by this team.
What PharmaCyte has accomplished with the 16-member Diabetes Consortium is to essentially speed up the time it will take to get the company’s diabetes treatment into human clinical trials. The treatment they’re all working to advance combines PharmaCyte Biotech’s signature live-cell encapsulation technology, Cell-in-a-Box®, with a novel cell line, called Melligen cells, that produces insulin in response to a patient’s blood sugar levels.
Earlier this month the first of the Diabetes Consortium’s work in animals with the Melligen cells returned favorable data to PharmaCyte and its investors. The company announced that its latest preclinical safety study showed that Melligen cells are as safe as the cells that were encapsulated with the Cell-in-a-Box technology and then used together with the cancer drug ifosfamide to treat patients with advanced pancreatic cancer in previously conducted clinical trials.
These results mean that the cells used in the company’s diabetes treatment are just as safe to use as the cells that the company uses in its pancreatic cancer treatment that is preparing to go into a Phase 2b or "mini" Phase 3 human clinical trial. PharmaCyte announced that additional safety, as well as efficacy and dose finding studies, of the Melligen cells are planned for the near future.
The additional studies that lie ahead for PharmaCyte will be where the Diabetes Consortium will shine. Dr. Eva Maria Brandtner is the Director of Diabetes Program Development at PharmaCyte, and like a conductor, she is responsible for orchestrating this large group of experts to a successful conclusion. After all, it will be the expertise that each member brings to the group that will benefit PharmaCyte and its treatment.
The CEO of PharmaCyte, Kenneth L. Waggoner, explains why the Diabetes Consortium was put together and some of its more important benefits. "We knew we had to find a way to condense the time it would take to get into clinical trials, given the world-wide and growing epidemic of patients who need insulin to treat their disease,” said Kenneth L. Waggoner. “We have assembled five prestigious research universities working on parallel but complementary research tracks at the same time, rather than conducting experiments sequentially as would normally be the case in a single institutional setting."
"This will dramatically shorten the time we need to conduct the bench and animals studies that are necessary before clinical trials on humans are undertaken. In addition, we have scientists in our Diabetes Consortium who have ‘one of a kind’ animal models that accelerate the time an animal develops diabetes -- again compressing the overall development timeline," said Waggoner.
The multidisciplinary, international team of experts that comprise this unique consortium should rapidly advance the development of PharmaCyte Biotech’s encapsulated cell based therapy for diabetes and should accelerate the development process as well as provide both compelling and comprehensive safety, dosing and clinical efficacy data.
I have been here since February 2014. This is my first bio and I have seen many take a stab on answering those questions. However, I have not known one person to make accurate predictions, including yours truly. Things seem to take longer with bios Just as you mentioned. So I would caution anyone to answer this type of question because someone is bound to try and hold them to it and very likely to call the company on the prediction a layman has made when it doesn't happen.
Best to just know all of these things are on the agenda or possible outcomes and just wait for them to happen, IMO.
Absolutely. Too many stuck in the past and trying to bring others into their miserable states of mind. I would never follow the advise of someone with an axe to grind. How can they possibly see anything when blinded by their own personal disgruntled past choices. Everyone knows any type of investment is risky. Those who can't move on from their own poor choices are stuck in a miserable state of being and we know misery loves company. I pass and chose to live in the present.
It's a tactic that does work to discourage those with a limited understanding of the company. That is why providing additional sources to back a perspective is important. Those who are really interested will take the time to do their DD and make an educated decision regarding all factors at play here...
Thanks for that DD.
I disagree, what you see below has all been accomplished in the past 18 months - Since KW came on board. Don't believe me, investors, do your own DD. The truth speaks for itself. No spin needed.
"The financial position of PharmaCyte Biotech has become the strongest in the Company’s history. We are virtually debt-free and have access to all of the necessary capital required to meet both our short-term and long-term financial commitments.
We are well underway in completing the necessary steps to commence three clinical trials using our Cell-in-a-Box® technology. The first will be a Phase 2b clinical trial of our pancreatic cancer treatment. Our pancreatic cancer treatment will be compared “head-to-head” with the current best available treatment for the disease. This treatment is the combination of gemcitabine with Celgene’s drug Abraxane®. We expect to begin this clinical trial in the third quarter of 2015.
We are also underway in completing preparations for two other clinical trials related to the “quality of life” of patients with advanced pancreatic cancer and other abdominal tumors. These clinical trials deal with treatments for the: (i) intractable and virtually untreatable pain about 20-25% of patients with advanced pancreatic cancer suffer from; and (ii) accumulation of fluid (knows as ascites) in the abdomen that is extremely uncomfortable for patients with pancreatic cancer and other abdominal tumors. Because ascites fluid can contain cancer cells and these cells can seed and form new tumors, oncologists must frequently remove ascites fluid from patients. This is costly and painful. There is no treatment on the market to slow down the accumulation of ascites fluid. We believe our treatment will. We expect to start both clinical trials late in the third quarter of 2015.
We commenced and concluded our first preclinical study (4 groups of tumor bearing mice) that was conducted by Translational Drug Development (TD2) in the U.S. to determine the ability of our treatment of Cell-in-a-Box® plus ifosfamide to delay the accumulation of malignant ascites fluid. An expanded study (12 groups of mice) is currently being conducted by TD2. This study is designed to further define the parameters that will be needed for our future clinical trial in this area.
Our treatment for advanced, inoperable pancreatic cancer was granted the Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in December 2014. Granting of this designation means that PharmaCyte Biotech will receive 7 years of marketing exclusivity in the U.S. for its pancreatic cancer treatment and reduced taxes and assistance from the FDA in the further development of our treatment.
We obtained the worldwide rights to use a genetically modified cell that produces insulin on demand in direct proportion to the amount of glucose (sugar) in their surroundings. These rights were obtained from the University of Technology Sydney (UTS) where Prof. Ann Simpson, along with her colleagues at UTS, have spent years developing this unique cell line called “Melligen.”
We have completed a study at the University of Veterinary Medicine Vienna (UVM) to determine if the Melligen cells have the propensity to form tumors in the body. The Melligen cells were found to be as “safe” as the genetically modified cells used in the previous clinical trials in pancreatic cancer in terms of potential tumor formation in the body over time. We have also begun studies to establish the parameters by which the Melligen cells can produce and store insulin in response to glucose levels in their surroundings.
Through a Collaborative Research Agreement with the Vorarlberg Institute for Vascular Investigation and Treatment in Austria, Dr. Eva-Maria Brandtner has been appointed our Director of Diabetes Program Development. Dr. Brandtner was responsible for studies with the Melligen cells during her previous tenure with our partner, Austrianova, as its Chief Scientist.
An international Diabetes Consortium has been established by PharmaCyte Biotech. The Diabetes Consortium brings together a global coalition of world class experts from various universities and institutions in several countries around the world. All 16 members of the Consortium are committed to developing a treatment for insulin-dependent diabetes using PharmaCyte Biotech’s Cell-in-a-Box® live-cell encapsulation technology combined with human non-pancreatic, insulin-producing cells.
Several contracts and Collaborative Research Agreements have been entered into with leading research universities, scientists, academics and institutions around the globe that will facilitate PharmaCyte Biotech’s development of its cancer and diabetes treatments.
We obtained the exclusive worldwide license from Austrianova to use the Cell-in-a-Box® live cell encapsulation technology in combination with compounds obtained or developed from constituents of Cannabis, known as cannabinoids, for the treatment of diseases and their related symptoms.
Progress is underway at the University of Northern Colorado in an attempt to identify a cell line that can be encapsulated using the Cell-in-a-Box® technology, which, in turn, can be used together with cannabinoid or cannabinoid-like prodrugs as treatment for deadly and difficult to treat cancers, such as brain cancer.
The company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to emphasize that it has fully transitioned from a nutraceutical company to a purely biotechnology company.
Significant changes have been made at the Board of Directors level, including a new member with major pharmaceutical experience being named as our first replacement Board member. Others members are in the final interview process, all of whom will be widely experienced in the life sciences."
http://www.biomedreports.com/20150518222991/qaa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction.html
Also important to know regarding CIAB's technology...
"Q: You’ve had several major peer-reviewed papers? What is the significance of these studies? Can you explain why these are key to PharmaCyte’s medical story?
KENNETH: There are three papers that have a direct effect on what we are doing at PharmaCyte Biotech. The first two have to do with our pancreatic cancer treatment and the third concerns our work with diabetes.
The first paper reports on the results of the Phase 1/2 clinical trial of our treatment in patients with advanced, inoperable pancreatic cancer. In this trial, 14 elderly and very sick patients were treated at a single study site in Germany with the combination of Cell-in-a-Box® plus low dose ifosfamide. All patients were treated with a single implantation of 300 Cell-in-a-Box® capsules with each capsule containing about 10,000 cells that are capable of converting the ifosfamide into its cancer-killing form. The capsules were implanted, using interventional radiography, with a catheter that was threaded through an artery in the leg to the pancreas where they were deposited as close to the cancerous tumor as possible. Then ifosfamide was administered intravenously at one-third of its “normal” dose. Only two treatments of ifosfamide were given about three weeks apart. This was a single-arm study; no comparator arm was used, but the results were compared to historical data for gemcitabine - the only drug approved at that time for the treatment of advanced, inoperable pancreatic cancer.
The results from this clinical trial showed that the Cell-in-a-Box® plus low dose ifosfamide combination increased the average lifespan of patients from about 5.7 months for gemcitabine to about 11 months with the combination and doubled the percentage of one-year survivors from 18% to 36%. Importantly, while the use of gemcitabine was associated with serious side effects, virtually no side effects were seen with the Cell-in-a-Box® plus ifosfamide treatment. The “quality of life” of the patients was vastly improved because of treatment. In addition, some beneficial effect was seen on metastatic lesions (from the pancreatic cancer) in the liver as a result of treatment with the Cell-in-a-Box® plus low dose ifosfamide combination. Thus, the major conclusion from this trial was that the combination of Cell-in-a-Box® plus low dose ifosfamide was a safe and effective treatment for patients with advanced, inoperable pancreatic cancer.
The second paper reports the results of a single-arm Phase 2 clinical trial in which 13 patients with advanced, inoperable pancreatic cancer were treated at 4 study sites in Europe. The only difference between this Phase 2 clinical trial and the Phase 1/2 clinical trial was that the dose of ifosfamide used was doubled to two-thirds of the normally used dose of this drug. This was done in an attempt to increase the anticancer effectiveness of the ifosfamide. The main conclusion taken from this trial was that the combination of Cell-in-a-Box® plus one-third the normal dose of ifosfamide was the appropriate treatment to use in all future clinical trials for a safe and effective antitumor treatment of advanced, inoperable pancreatic cancer.
The third peer reviewed paper titled, “Reversal of diabetes following transplantation of an insulin-secreting human liver cell line: Melligen cells” was published in the journal Molecular Therapy – Methods & Clinical Development. The article describes the development and preclinical testing of the Melligen cells developed by Prof. Simpson and her colleagues at UTS. Most importantly, however, the authors note that, for the Melligen cells to be effective in treating Type 1 diabetes in humans where the insulin-producing ß cells of the pancreas have been destroyed, it will be necessary to protect those cells from rejection by the body’s immune system after they have been introduced into the body. The article points out that one way to protect the Melligen cells would be to encapsulate the cells in protective “cocoons” prior to being placed into a diabetic patient. If this is done, the authors believe that encapsulated Melligen cells may offer a cure for Type 1 diabetes.
PharmaCyte Biotech’s live cell encapsulation technology, Cell-in-a-Box®, appears to be the ideal encapsulation technology for this purpose. In fact, Melligen cells have already been successfully encapsulated using the Cell-in-a-Box® process and experiments are already underway to ensure that encapsulation does not detract from the beneficial properties of the Melligen cells in any way."
http://www.biomedreports.com/20150518222991/qaa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction.html
The support is great to hear, Pete. You, I and many others have been supporters a while, and for good reason. News will come regarding recent trials. I am cautious about when the news will come but I do know it will come. I expect to continue to hear good results regarding Cell in a Box (R) technology.
Q. What makes your platform technology, Cell-in-the-Box, a value proposition?
KENNETH:
Cell-in-a-Box® is a remarkably versatile platform technology that can be used to develop treatments for all kinds of serious diseases, such as cancer and insulin-dependent diabetes. Cell-in-a-Box® is a type of technology where genetically modified living cells are encapsulated in small, pin-head-sized, spherical protective cocoons. These cocoons, or capsules, have pores in their outer shell that allow nutrients to enter the capsules to nourish the cells inside and to allow waste products from those cells to leave the capsules. The capsules are protective of the cells inside them because their pores are too small to allow the encapsulated cells to escape, where they would be destroyed by the patient’s immune system, and the pores are too small to allow the cells from the patient’s immune system to enter the capsules and destroy the cells inside.
Cell encapsulation has been around for many years. A number of materials have been used, the most common being alginate which is derived from seaweed. PharmaCyte Biotech is using cellulose sulphate for its cell encapsulation. Cellulose sulphate offers a number of advantages over other encapsulation materials because it is derived from a naturally occurring plant derived-polymer that is relatively easy to obtain at reproducible quality and is free from impurities. In addition, it has excellent biocompatibility. Cells in the capsules survive well and even grow within the capsules. Further, once the capsules are implanted into a body, they are not rejected by the body’s immune system and there is no immune or inflammatory response against the capsule material or the cells within the capsules. Cellulose sulphate encapsulated cells have already been tested in two human clinical trials and have been shown to be safe. In these trials, the cells in the capsules allowed lower, non-toxic doses of a chemotherapy drug to have equal or greater anti-tumor effects than standard, toxic doses of the same drug.
The Cell-in-a-Box® capsules are extremely robust and do not break down even after two years in a human body. The strength of our capsules allows them to be implanted using a needle or a catheter without damage to the patient. In addition, capsules containing living cells can be frozen and stored for more than 5 years, and when thawed, the frozen cells come back to life with more than 95% viability. These properties are important for long-term storage and for shipment over long distances as would be required for the commercialization of our encapsulated products. To our knowledge, no other form of live-cell encapsulation produces capsules that possess these unique properties. Without the ability to freeze the encapsulated cells, the capsules would need to be used almost immediately after production. This unique advantage alone sets PharmaCyte Biotech apart from any other cell encapsulation company in the world.
http://www.biomedreports.com/20150518222991/qaa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction.html
What is amazing is that anyone would try to spin this interview into more than just an informational interview. All I can hope is that the average reader is not so paranoid and they can do their own DD to see that all mentioned in the interview is valid AND achieving what Ken has in 18 months is truly notable.
This Q & A with Ken Waggoner is a must read for all shareholders. Nice DD, thanks... I think Ken sums up very well his accomplishments since coming on board...
Q: Can you describe some of the major milestones you’ve been able to accomplish since coming on board?
KENNETH: First and foremost, PharmaCyte Biotech has been completely transformed from a nutraceutical company into a pure biotechnology company. We are no longer in the nutraceutical business. Some of the other major milestones include the following:
· The financial position of PharmaCyte Biotech has become the strongest in the Company’s history. We are virtually debt-free and have access to all of the necessary capital required to meet both our short-term and long-term financial commitments.
· We are well underway in completing the necessary steps to commence three clinical trials using our Cell-in-a-Box® technology. The first will be a Phase 2b clinical trial of our pancreatic cancer treatment. Our pancreatic cancer treatment will be compared “head-to-head” with the current best available treatment for the disease. This treatment is the combination of gemcitabine with Celgene’s drug Abraxane®. We expect to begin this clinical trial in the third quarter of 2015.
· We are also underway in completing preparations for two other clinical trials related to the “quality of life” of patients with advanced pancreatic cancer and other abdominal tumors. These clinical trials deal with treatments for the: (i) intractable and virtually untreatable pain about 20-25% of patients with advanced pancreatic cancer suffer from; and (ii) accumulation of fluid (knows as ascites) in the abdomen that is extremely uncomfortable for patients with pancreatic cancer and other abdominal tumors. Because ascites fluid can contain cancer cells and these cells can seed and form new tumors, oncologists must frequently remove ascites fluid from patients. This is costly and painful. There is no treatment on the market to slow down the accumulation of ascites fluid. We believe our treatment will. We expect to start both clinical trials late in the third quarter of 2015.
· We commenced and concluded our first preclinical study (4 groups of tumor bearing mice) that was conducted by Translational Drug Development (TD2) in the U.S. to determine the ability of our treatment of Cell-in-a-Box® plus ifosfamide to delay the accumulation of malignant ascites fluid. An expanded study (12 groups of mice) is currently being conducted by TD2. This study is designed to further define the parameters that will be needed for our future clinical trial in this area.
· Our treatment for advanced, inoperable pancreatic cancer was granted the Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in December 2014. Granting of this designation means that PharmaCyte Biotech will receive 7 years of marketing exclusivity in the U.S. for its pancreatic cancer treatment and reduced taxes and assistance from the FDA in the further development of our treatment.
· We obtained the worldwide rights to use a genetically modified cell that produces insulin on demand in direct proportion to the amount of glucose (sugar) in their surroundings. These rights were obtained from the University of Technology Sydney (UTS) where Prof. Ann Simpson, along with her colleagues at UTS, have spent years developing this unique cell line called “Melligen.”
· We have completed a study at the University of Veterinary Medicine Vienna (UVM) to determine if the Melligen cells have the propensity to form tumors in the body. The Melligen cells were found to be as “safe” as the genetically modified cells used in the previous clinical trials in pancreatic cancer in terms of potential tumor formation in the body over time. We have also begun studies to establish the parameters by which the Melligen cells can produce and store insulin in response to glucose levels in their surroundings.
· Through a Collaborative Research Agreement with the Vorarlberg Institute for Vascular Investigation and Treatment in Austria, Dr. Eva-Maria Brandtner has been appointed our Director of Diabetes Program Development. Dr. Brandtner was responsible for studies with the Melligen cells during her previous tenure with our partner, Austrianova, as its Chief Scientist.
· An international Diabetes Consortium has been established by PharmaCyte Biotech. The Diabetes Consortium brings together a global coalition of world class experts from various universities and institutions in several countries around the world. All 16 members of the Consortium are committed to developing a treatment for insulin-dependent diabetes using PharmaCyte Biotech’s Cell-in-a-Box® live-cell encapsulation technology combined with human non-pancreatic, insulin-producing cells.
· Several contracts and Collaborative Research Agreements have been entered into with leading research universities, scientists, academics and institutions around the globe that will facilitate PharmaCyte Biotech’s development of its cancer and diabetes treatments.
· We obtained the exclusive worldwide license from Austrianova to use the Cell-in-a-Box® live cell encapsulation technology in combination with compounds obtained or developed from constituents of Cannabis, known as cannabinoids, for the treatment of diseases and their related symptoms.
· Progress is underway at the University of Northern Colorado in an attempt to identify a cell line that can be encapsulated using the Cell-in-a-Box® technology, which, in turn, can be used together with cannabinoid or cannabinoid-like prodrugs as treatment for deadly and difficult to treat cancers, such as brain cancer.
· The company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to emphasize that it has fully transitioned from a nutraceutical company to a purely biotechnology company.
· Significant changes have been made at the Board of Directors level, including a new member with major pharmaceutical experience being named as our first replacement Board member. Others members are in the final interview process, all of whom will be widely experienced in the life sciences.
http://www.biomedreports.com/20150518222991/qaa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction.html
He was appointed in November of 2013. And look at all that he has accomplished in less than 2 years. Pretty amazing, IMO.
Don't worry trently. There was just nothing to say yesterday. The interview conducted by a bio journalist is something to talk about today, however. :)
This is what I am awaiting to hear news about this year... I like that Ken made it clear to us, shareholders, what milestones we expect to accomplish this year.
"1. Complete the population of our Board of Directors with individuals who have extensive experience in life sciences and who have associated business expertise.
2. Fully populate our Scientific Advisory Board with world-class physicians and scientists experienced in the fields of cancer and diabetes.
3. Initiation of the Phase 2b clinical trial in Australia in patients with advanced pancreatic cancer. This is expected to begin in late 3Q2015.
4. Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment dealing with pain associated with advanced pancreatic cancer. This trial, to be conducted in the U.S., is expected to begin in late 3Q2015.
5. Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment in slowing the accumulation of malignant ascites fluid. This trial, to also be conducted in the U.S., is expected to occur in late 3Q2015 or early 4Q2015.
6. The initiation of these three clinical trials is dependent on the approval for use of the Cell-in-a-Box® live cell encapsulation facility that has been constructed in Bangkok, Thailand, by our partner, Austrianova. This facility must be approved as being compliant with current Good Manufacturing Practices (cGMP) standards by Thailand’s and Australia’s drug regulatory authorities as well as by the U.S. FDA.
7. Completion of our laboratory and small animal studies with the Melligen cells that are necessary to develop our treatment for insulin-dependent diabetes. These studies are designed to obtain data that will be required by regulatory authorities before any human clinical trials can occur."
There are new people who visit the boards all the time. This interview is very informative about what Ken has done to build our infrastructure as well as what is to be expected this coming year...
No one said it was new news... It is an interview to inform those who don't already know. Additionally, it is an interview done with a bio journalist. I am not sure but this may be a first, adding credibility that this biotech has something of value to the medical community.
What I did learn is that the pain studies with TD2 may begin before the ascites studies making it clear there will be 3 separate trials scheduled to begin before the end of the year.
"Initiation of the Phase 2b clinical trial in Australia in patients with advanced pancreatic cancer. This is expected to begin in late 3Q2015.
Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment dealing with pain associated with advanced pancreatic cancer. This trial, to be conducted in the U.S., is expected to begin in late 3Q2015.
Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment in slowing the accumulation of malignant ascites fluid. This trial, to also be conducted in the U.S., is expected to occur in late 3Q2015 or early 4Q2015."
http://www.biomedreports.com/20150518222991/qaa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction.html
What Do You Know About Pharmacyte Biotech Inc (OTCMKTS:PMCB)
BY JUSTIN KINNEY ON MAY 18, 2015 MICRO CAP INSIDER, SMALL CAPS
Pharmacyte Biotech Inc (OTCMKTS:PMCB) continues to consolidate well over $0.15 after the explosive move the stock made from $0.10 to highs over $0.25.
PMCB continues to command a massive following that supports the stock and for good reason; when PMCB heats up it goes big running from a dime to over $0.60 a share this time last year.
Pharmacyte Biotech Inc (OTCMKTS:PMCB) is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon their unique, proprietary and patented cellulose-based live cell encapsulation technology known as Cell-in-a-Box®.
The live-cell encapsulation technology employed by Pharmacyte Biotech is a way to enclose living cells in protective “cocoons” about the size of the head of a pin. Each capsule can enclose approximately 10,000 cells and the technology is considered a “platform” upon which treatments can be developed.
Dr.Mark Rabe, chairman of the advisory board of Pharmacyte Biotech subsidiary, Medical Marijuana Sciences (MMS) summed it up perfectly when he said ”The live cell encapsulation platform employed by Nuvilex is a unique patented technology on which treatments can be developed for deadly and debilitating diseases such as cancer and diabetes. The technology has shown to be successful in the treatment of pancreatic cancer in initial clinical trials using the conventional chemotherapy drug ifosphamide. ”
To get a sense of just how valuable this technology could be, consider a recent report published by U.S. based market research company, Transparency Market Research “ the global diabetes devices and drugs market was valued at USD 54.04 billion in 2012 and is estimated to reach a market worth of USD 83.0 billion in 2019 growing at a CAGR of 5.9% from 2013 to 2019.
Many investors in the Company view Pharmacyte Biotech Cell-in-a-Box® cell encapsulation technology as THE future of diabetes treatment and suggest the Company is a prime buy out candidate from a major such as Bayer who may be closely watching PMCB.
PMCB has benefited from the pot connection; the sector is heating up again big time with a recent report from MMJ Business Daily suggesting that 2015 is expected not only to see more investment dollars flow into the market but it could even outpace the growth rate seen in 2014. States like Nevada, Illinois, Massachusetts, Oregon, and Alaska have all been identified as industry drivers this year. Furthermore, the rise in “big money” from some major investment funds has just started to hit the sector.
Pharmacyte Biotech subsidiary, Medical Marijuana Sciences, Inc., is exploring the benefits of using the Cell-in-a-Box(TM) technology in optimizing the anticancer effectiveness of cannabinoids while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments.
PMCB landed a leading figure in the medical marijuana field in Dr. Mark L. Rabe who was appointed as the Chairman of the Scientific Advisory Board of Medical Marijuana Sciences (MMS).
In fact Pharmacyte Biotech has been very successful in attracting top talent to the Company including their COO Dr. Crabtree who used to work at Bristol Meyers and successfully managed the project that achieved FDA approval for Taxol. Another huge asset is their Chief Scientific Officer ; Dr. Robert F. Ryan an expert in helping small companies in bringing their products to market through the rigorous FDA approval process.
Pharmacyte Biotech has made some huge steps recently towards accelerated FDA approval for its pancreatic cancer treatment using Phase 2b data that outperformed Eli Lilly’s Gemzar in prior trials; according to available information the Cell-In-The-Box technology beats the current Gold Standard on The market, and we are talking about a market worth billions. Pharmacyte Biotech has made some huge steps recently towards accelerated FDA approval for its pancreatic cancer treatment using Phase 2b data that outperformed Eli Lilly’s Gemzar in prior trials. The New Year promises to be big for Pharmacyte Biotech. We will be updating on PMCB when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with PMCB.
Disclosure: we hold no position in PMCB either long or short and we have not been compensated for this article.
Hey Bill, how are the hills of Tennessee? Good to hear from you...
I disagree, everything we do builds tomorrow, which is exactly the point I am making. We are in the midst of the process. Just think about baking a cake, first you determine what ingredients you need, then you get them, then you start putting it all together, then it has to bake a while. It's not magic, it takes time and effort. The principles are the same in all of life. Everything is a process. Just because someone may demand that the cake should be ready in 10 minutes, won't make it happen. They can even determine it will take 50 minutes to bake but that could vary depending on the altitude, the oven, the type of pan used, etc. etc... Life teaches these lessons...
We are good though, mixer. I think I get your point. We just have different experiences and aspirations.
Thanks Bio...
So let's take a look at the most recent and material past events. Our acquisitions of Cell in a Box technology, Dr Von Hoff and Ken Waggoner. This is enough to pull me into the present since the old is truly irrelevant, especially in light of the aforementioned. The technology is revolutionary (CIAB), the studies with Dr Von Hoff and TD2 are treating pain associated with pancreatic cancer and malignant ascites for all abdominal cancers, and Ken Waggoner has built the infrastructure to take us where we need to be for success. A good example of his tactics is the diabetes consortium that could help to cure diabetes.
Like it or not, the past is gone. All we have is today and our future.
http://www.pharmacytebiotech.com
Get 'em Pistol Pete and safe travels... :)
Thanks Pete. How is your trip?
I expect this process to be completed in time, just like everything else. In all business, as in life, target goals are set to keep folks working towards a common objective. It's pretty basic stuff. No target, no focus. Businesses reset targets all the time. That is why business plans are written over and over again. It is also why we have quarterly reports, things change. Those who can adapt to change, survive. To be inflexible, is to break under pressure... Pretty basic IMO, but glad to offer my perspective...
"Preparations for the Phase 2b clinical trial in patients with advanced, inoperable pancreatic cancer are ongoing. Major documents, including the Investigators Brochure and a clinical protocol (a recipe for conducting the clinical trial) are in preparation, with the assistance of Clinical Network Services (CNS) - one of Australia's leading Clinical Research Organizations. The target date for the initiation of the Phase 2b clinical trial in Australia is the third quarter of 2015.
We initially reported that we expected to begin our Phase 2b clinical trial in the first quarter of 2015; however, we are awaiting the Good Manufacturing Practices (GMP) regulatory approval process that our partner, Austrianova, is currently involved with in order to get the GMP-compliant facility at the Thai Science Park in Bangkok, Thailand, approved to produce Cell-in-a-Box® capsules for human clinical trials. Austrianova believes the process will now be completed in the third quarter of 2015."
http://globenewswire.com/news-release/2015/03/16/715481/10124852/en/PharmaCyte-Biotech-Provides-Update-on-Corporate-Developments-and-Progress-With-Cancer-and-Diabetes-Programs.html
Absolutely and I can afford my investment so WTF, it's worth the risk, IMO. LOL
No revenue yet. But a lot of work being done behind the scenes to make that happen. I am long term here. I expect Cell in a Box to be a blockbuster in the future. I can weather the costs to make that happen...
It is activated by low oxygenation, yes, but it is only one drug. We can target more than one drug with our delivery system. That is why we are conducting a follow up preclinical study with 12 different treatments that can be used for all abdominal cancers. Revolutionary... Merck's is for pancreatic cancer alone. Because ours is a delivery system, there are so many potential uses...
"In the initial study, mice given an aggressive human ovarian cancer (ES-2), which produces significant amounts of malignant ascites fluid, were divided into 4 groups. There were 10 mice in each group. The mice in Group 1 served as a control group. Group 2 was made up of mice treated with PharmaCyte Biotech’s pancreatic cancer treatment. Group 3 was treated with cisplatin, a chemotherapy drug often used to treat ovarian cancer. Group 4 was treated with a combination of PharmaCyte Biotech’s pancreatic cancer treatment and cisplatin.
The follow-up study will use the same ES-2 ovarian cancer model. In this study, the mice will be divided into 13 different treatment groups, with 10 mice in each group. The follow-up study is designed to better define the parameters that will be needed to design a future Phase 1 clinical trial in humans that suffer from malignant ascites fluid accumulation as a result of their abdominal cancers, such as pancreatic, liver, ovarian, uterine and colon. The study will be conducted by Translational Drug Development (TD2) in the U.S. which was designed by pancreatic cancer expert Dr. Daniel D. Von Hoff, Chief Development Officer of TD2."
http://www.pharmacytebiotech.com/pharmacyte-biotech-initiates-expanded-follow-study-united-states-accumulation-malignant-ascites-fluid/
No worries. So many looking for a cure out there but the delivery system we have is what makes us unique...
Here is an article regarding the approval and treatment. No special delivery method mentioned. Just the prodrug. If there were a special delivery method, that would be competition for us, but their treatment is like all other chemo drug combo treatments. It may work better than the others but Cell in a Box IS a delivery method which is why it is revolutionary. It could possibly be used to deliver Merck's drug combo...
http://wkrn.membercenter.worldnow.com/story/29039640/merck-kgaa-darmstadt-germany-receives-fda-fast-track-designation-for-evofosfamide-for-the-treatment-of-patients-living-with-advanced-pancreatic-cancer
Evofosfomide is a prodrug just like ifosfomide. However, Merck does not use a targeted method like PMCB with Cell in a Box technology. The delivery method is the difference with CiaB. Less of a prodrug is needed which reduces toxicity.
We ended nicely today on low volume, up 6.45%. The news shared earlier this week regarding the Melligen cells being proven safe in preclinical trials was significant.
http://www.nasdaq.com/press-release/pharmacyte-biotechs-melligen-cells-prove-safe-in-first-preclinical-test-20150506-00820
Looking good so far today. Nice volume, nice forward movement. Let's hope we close nicely into the weekend...
Great post Rudy. Summarizes our status on several fronts very well. Keeping a mindset of a long hold is important. Otherwise you will get caught up in unrealistic urgency that something needs to happen now or soon. It will happen when it happens. As long as we are moving forward, even with the smallest of milestones, I look forward to a multitude of successes. Long and steady...
"Our favorite holding period is forever."
"Why not invest your assets in the companies you really like? As Mae West said, 'Too much of a good thing can be wonderful'."
"If past history was all there was to the game, the richest people would be librarians."
"Look at market fluctuations as your friend rather than your enemy; profit from folly rather than participate in it."
"Only buy something that you'd be perfectly happy to hold if the market shut down for 10 years."
"A public-opinion poll is no substitute for thought."
"Someone is sitting in the shade today because someone planted a tree a long time ago."
"No matter how great the talent or efforts, some things just take time. You can’t produce a baby in one month by getting nine women pregnant."
Warren Buffett
Some of my personal favorites...
I believe very strongly in the potential revolutionary health benefits of Cell-in-a-Box(R) technology. Long and strong here...
http://www.pharmacytebiotech.com/live-cell-encapsulation/
Pharmacyte Biotech is Redefining the Term "Diabetes Treatment" (PMCB, NVO, MNKD)
Novo Nordisk A/S (NYSE:NVO) and MannKind Corporation (NASDAQ:MNKD) tend to garner the most attention in the diabetes space, but Pharmacyte Biotech Inc. (OTCMKTS:PMCB) may be sitting on the next big diabetes breakthrough.
When investors think of diabetes treatment stocks, names like MannKind Corporation (NASDAQ:MNKD) and Novo Nordisk A/S (NYSE:NVO) come to mind. And well they should. Novo Nordisk is the biggest supplier of insulin in the world, and controls half of that market by itself. MannKind changed the world - at least in a small way - last year by winning the FDA's approval for an inhaled insulin, negating the need for constant injections with a needle.
Another name may soon be joining that list of highly-regarded diabetes treatment stocks, however... Pharmacyte Biotech Inc. (OTCMKTS:PMCB).
Diabetes, in simplest terms, is an excess of glucose (sugar) in the bloodstream. Normally the human body can process and remove this glucose with insulin produced naturally produced by the pancreas. For diabetics, however, the insulin-producing beta cells in the pancreas are destroyed by that body's immune system. Though type 2 diabetes can often be treated by weight loss and better dietary habits, type 1 diabetes - "the bad one" - cannot be self-regulated by diet and exercise.
Proposed solutions to the type 1 diabetes problem have been varied, and each has its merits.
The simplest solution is injecting insulin into the diabetic patient's bloodstream. This is the solution Novo Nordisk introduced nearly a century ago, and is the primary approach still used today. The downside? Even a small needle is still a needle, and the required dosage is forever changing with a diabetic's glucose levels.
MannKind Corporation arguably introduced the biggest leap in the world of insulin treatments last year, winning the FDA's approval for AFREZZA... and inhaled form of insulin. While this approach circumvents the needle, questions remain over the long-term safety of delivering insulin through the lungs.
And in between those two milestones, several companies toyed with the idea of depositing or replacing the islet cells in the pancreas as a cure for type 1 diabetes, which would effectively serve as a cure for the disease. These ideas showed promise too, but were largely problematic. Either they were still ultimately attacked by the immune system, or the mechanical structure required to place them in the pancreas failed.
To this day, the only viable treatment of type 1 diabetes is the original one... forcing insulin into the bloodstream from outside the body, one way or another. Pharmacyte Biotech may be about to change this with what could effectively be seen as a cure for the disease.
The technology is called Cell-in-a-Box. Pharmacyte Biotech developed it as a means of depositing living, normally-functioning cells into a particular part of the body where their presence would have a therapeutic effect. In this case, the cells "in the box" would be insulin-producing islet cells placed within the pancreas. Just like a patient's own cells would detect the presence of glucose and begin producing insulin, the cells inside the encapsulation are capable of sensing high levels of glucose and produce an appropriate amount of insulin.
It's an idea that's been tried before, but as was noted, it's an idea that's generally failed one way or another. The game-changer Pharmacyte brings to the table, however, is the Cell-in-a-Box encapsulation biotechnology.
The key to Cell-in-a-Box is the combination of the right polymers added to the mix in the right way at the right time.
The process starts out with a mix of live cells (insulin-producing pancreatic cells in this case) and a polymer which is then passed through a droplet-forming device into a bath of another proprietary polymer. When the two polymers meet, a membrane is formed, with the living cells inside of it. This membrane keeps the cells in, lets insulin out, lets nutrients in, and most important, prevents the body's immune system from destroying these cells.... something most previous encapsulation attempts couldn't do.
And that's the proverbial quantum leap for diabetics - an encapsulation technology that actually works for the long haul.
There's still work to be done. Cell-in-a-Box as a treatment pathway for type 1 diabetes is currently in the preclinical research phase, though it was recently validated as a safe biotechnology by University of Veterinary Medicine Vienna. Then again, its confirmed safety can't even be counted as a pleasant surprise, as it's the same delivery technology that's now part of a phase 2 study as a treatment means for pancreatic cancer.
Whatever the case, Pharmacyte Biotech is one step closer to beginning human clinical trials of the diabetes treatment approach. That alone could prove catalytic for its stock.
http://www.smallcapnetwork.com/Pharmacyte-Biotech-is-Redefining-the-Term-Diabetes-Treatment-PMCB-NVO-MNKD/s/via/10/article/view/p/mid/3/id/534/
Thanks for sharing your story. It really helps paint the picture of how significant this treatment could be.
I have been holding over a year now and it is so much fun to get into trials. This is my first bio but I feel like the human trials are going to be the best part. That will be when we can see the impact of the treatments. It will feel good to be a part of improving the "quality of life" for so many.
Enjoy the ride and I wish you and yours the best...
It's also kind of exciting to see this news make Yahoo's Home Page. This is significant news for stakeholders everywhere, including the millions who have diabetes...
https://www.yahoo.com
This is an update that we, as shareholders have been waiting to hear.
3/16/15 - "Studies are in progress at the University of Veterinary Medicine, Vienna (UVM) to determine if Melligen (human, non-pancreatic, insulin-producing) cells are tumorigenic and to establish parameters by which these cells (human, non-pancreatic, insulin-producing) can produce and store insulin in response to glucose levels in their surroundings. The coordinator for these studies is Dr. Constantine Konstantoulas of UVM."
http://www.pharmacytebiotech.com/pharmacyte-biotech-provides-update-on-corporate-developments-and-progress-with-cancer-and-diabetes-programs/
5/6/15 - "We are pleased that our first test of the Melligen cells has shown favorable results. Given these results, we are moving forward with our efforts on multiple fronts to develop a treatment for insulin-dependent diabetes using PharmaCyte Biotech's Cell-in-a-Box(R) technology to encapsulate Melligen cells."
PharmaCyte Biotech's Melligen Cells Prove Safe in First Preclinical Test
Very good news for shareholders. Not meaningful for others.
http://finance.yahoo.com/news/pharmacyte-biotechs-melligen-cells-prove-133000003.html
PharmaCyte Biotech's Melligen Cells Prove Safe in First Preclinical Test
Today : Wednesday 6 May 2015
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 the Institute of Virology at the University of Veterinary Medicine Vienna, one of the partners in PharmaCyte Biotech's international Diabetes Consortium, has completed the first round of safety testing of the Melligen cells in mice.
The study showed that Melligen cells are as safe as the cells that were encapsulated with the Cell-in-a-Box® technology and then used together with the cancer drug ifosfamide to treat patients with advanced pancreatic cancer in previously conducted clinical trials. This safety study is the first study in animals of the Melligen cells that has been done as part of the work of the international Diabetes Consortium. Additional safety, as well as efficacy and dose finding studies, of the Melligen cells are planned for the near future.
Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, said, "We are pleased that our first test of the Melligen cells has shown favorable results. Given these results, we are moving forward with our efforts on multiple fronts to develop a treatment for insulin-dependent diabetes using PharmaCyte Biotech's Cell-in-a-Box® technology to encapsulate Melligen cells. We believe that, by implanting encapsulated Melligen cells into diabetic patients, we will be able to eliminate the need for daily injections of insulin in diabetic patients. In our opinion, this therapy is at the forefront of finding a cure for Type 1 diabetes and for those patients with Type 2 diabetes in need of insulin."
Melligen cells have shown promise as a potential treatment for insulin dependent diabetes through the genetic engineering of human, non-pancreatic beta cells that makes the Melligen cells capable of regulating blood sugar levels by producing insulin on demand. In the past, when Melligen cells were transplanted into diabetic mice, the blood glucose levels of the mice became normal. This observation illustrates that Melligen cells can reverse the diabetic condition in animals.
PharmaCyte Biotech has the exclusive worldwide rights to use the Melligen cells to treat diabetes. These rights were obtained from the University of Technology Sydney (UTS) where Prof. Ann Simpson, along with her colleagues at UTS, have spent years developing this unique cell line.
http://finance.yahoo.com/news/pharmacyte-biotechs-melligen-cells-prove-133000003.html