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Wow! That's not a good sign... LMAO
I guess I will be watching for quite a while.
Thanks Louie. I think I will put them back on my watch list. Who is Lap, btw?
Great info, GLTU...
I owned this one a few years ago and got out at .29. I see they are doing a lot more, focusing on HIV and overseas efforts is what is most notable for me.
If there are any long term holders here, what can you tell me about their current progress?
TIA
No, they did not report it and it is possible that they did not withdraw. I came to the conclusion myself by reading the meeting notes from the EMA and the company's PRs regarding ODD designations.
We applied circa September 2014. The December 2014 meeting notes showed they had questions for some companies and then the January 2015 notes showed that 14 companies withdrew their application. There were no notes as to denials for pancreatic cancer so I did not see that as a real possibility. I would have liked a PR regarding the EMA ODD application status but once we received FDA ODD, it was not necessary and I saw it was possible that we just withdrew.
I personally think that once we got ODD from the FDA, we decided to focus on our studies with TD2. After all, those trials will be coming up first. Also, we were granted FDA ODD in December 2014.
Each link I provided below supports everything I mentioned above. It may look like I over did it on the links but I was just trying to show "good faith", mixer.
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2015/01/WC500180405.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2014/12/WC500179564.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2014/12/WC500179288.pdf
http://www.dddmag.com/news/2014/10/nuvilex-applies-orphan-drug-designation-pancreatic-cancer-treatment
http://www.marketwatch.com/story/nuvilex-submits-application-for-orphan-drug-designation-to-the-european-medicines-agency-for-its-cell-in-a-boxr-treatment-for-pancreatic-cancer-2014-09-02
http://globenewswire.com/news-release/2014/12/22/693421/10113176/en/FDA-Grants-Orphan-Drug-Designation-to-Nuvilex-for-Pancreatic-Cancer-Treatment.html
Looks to me like we are going full speed ahead into trials. And long-term holders here know we have to dilute to pay for R&D... but we don't whine about it. We know it is what we have to do right now. And yes, we understand how it impacts our personal investment.
However, it is a matter of priorities and vision here. We have to get successfully through trials to get to market. I believe our investment will reach its full value when we start helping patients.
I think if you don't believe in what the company is doing and the full potential of this technology, this will be a real issue. However, if you do believe and you understand the business of R&D, it will be business as usual. Like it or not...
I was just trying to give you an opportunity to demonstrate some "good faith." Oh well...
Well, Cell in a Box(R) technology has only been licensed to PMCB for cancer since 2013. That is only 2 years. Also, Ken Waggoner has been here since late 2013, again, only 2 years. Any concerns about things that happened prior to 2013 are really unrelated to the current company's leadership and business model.
But it does sound so much more dramatic to make it sound like we have been working with this product for a decade. Only problem, it is just not true.
Fros, the good news is that this is science, which can be proven. In fact, Cell in a Box(R) technology has already been proven. This is evident by the number of peer reviewed studies reporting on the results of studies using Cell in a Box(R) technology. Peer reviewed, btw, means that other scientists verify the results. They are not misleading but simply reporting findings, related specifically to this technology. Nothing generic in these reports.
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.
The FDA will still need to approve but the chances of getting approval are much greater since the drug used is already approved, ifosfamide, and the device has proven to survive at least 2 years in the human body.
No need for major concern about this treatment getting FDA approval. We are already half way there.
Well we know the application was withdrawn. They can reapply when they start trials in 4Q. Please help me understand why this is so upsetting? Why do they need EMA ODD approval right now?
Also, we did not plan for FDA ODD and we did get that...
I think if a person needs everything to go according to plan, a biotech is certainly not the best investment. How could he or anyone for that matter, have known that follow-up studies would be needed. That is not speaking for him. It is just common sense.
Since this initial study for ascites, there have been 2 follow-up studies. One of them is still on-going. It is hard to report on something for which studies are still on-going.
http://www.marketwatch.com/story/pharmacyte-biotech-begins-second-follow-up-study-on-ascites-2015-07-23
Mixer, can you provide the link for that statement? I'd like to see the date that it was sent and the context in which the statement was made.
Thanks
Thanks Bio. :)
An absolutely false statement. Here is some of what has been accomplished by Ken Waggoner since he has come 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.pharmacytebiotech.com/qa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction/
However, as you shared with us a few months back, Dr Von Hoff and TD2 have a more progressive trial design for Phase 1, article link below. Also, TD2 has recently started using new technology to provide real-time patient feedback. TD2's entire focus is getting drugs to market more quickly. It is important to keep all information relevant to what is happening today with PharmaCyte and it's partners.
TD2 and Navigating Cancer Partner to Bring Patient-Reported Outcomes to Clinical Trials Through a Cutting-Edge Mobile Application
Leading patient engagement and mobile care management solution and precision oncology CRO partner to revolutionize patient engagement in clinical trials
Business Wire TD2
April 20, 2015 12:01 AM
SCOTTSDALE, Ariz. & SEATTLE--(BUSINESS WIRE)--
TD2, the precision oncology CRO, and Navigating Cancer, the leading web-based patient care and engagement solution for oncology clinics, today announced a partnership to improve the engagement of patients in clinical trials and bring patient-reported outcomes to the clinical trials process.
The integration with Navigating Cancer’s mobile care management solution will allow patients participating in TD2-managed clinical trials to record adherence and report how they are feeling in real time through a simple-to-use mobile application. This information will be provided to TD2’s participating oncology trial sites to enhance the care of patients enrolled in clinical studies. This access to patient-reported experiences on emerging therapies will provide biotechnology and pharmaceutical companies with new insights that could be used to improve trial designs, develop unique clinical trial endpoints and add value in reimbursement decisions.
“Real-time patient-reported data using Navigating Cancer’s mobile solution is an important component of the TD2 clinical trial process,” said TD2 CEO Stephen Gately, Ph.D. “ This data will be used to support more efficient patient-focused clinical trial designs, and to potentially identify regulatory opportunities for new medicines that improve patient symptoms and functional abilities.”
"As a company dedicated to improving health outcomes through patient engagement, we believe that providing patients in clinical trials with a convenient, mobile means of reporting their own experiences on an investigative therapy in real time will be a game-changer for patient-centered drug development.” said Gena Cook, CEO of Navigating Cancer. “We are excited to partner with TD2 to ensure that patient’s experiences are reflected in health outcomes.”
About Navigating Cancer
Navigating Cancer is the leading patient engagement platform and mobile care management solution for cancer centers across the United States. For patients, Navigating Cancer provides a single, comprehensive hub that operates with any electronic health record system, enabling them to stay seamlessly informed and engaged in their own care across multiple clinics, caregivers and geographies. For providers, Navigating Cancer offers a convenient, scalable solution for care management and engagement, a vital tool in the evolution to value-based medicine, and an agile means of satisfying current requirements for Meaningful Use, Commission on Cancer and new payment reform models. For more information, visit: https://www.navigatingcancer.com
http://www.medelis.com/clinical-cancer-research-abstracts/complete-phase-ib-trial-design/
http://finance.yahoo.com/news/td2-navigating-cancer-partner-bring-040100983.html;_ylt=AwrTceOoCrlVIIQA5_wnnIlQ;_ylu=X3oDMTByM3V1YTVuBGNvbG8DZ3ExBHBvcwMzBHZ0aWQDBHNlYwNzcg--
Absolutely, Pete. Cell in a Box(R) is a delivery system, not a drug. The drug it currently delivers (ifosfamide) has been on the market for years. There is no need to approve a drug here. Only to approve the delivery system which we already know can stay in a human body for 2 years without being rejected.
They also may be prohibited from buying if they have material information that would affect the price of the stock.
The Law
In August 2000, the Securities and Exchange Commission (SEC) adopted new rules regarding insider trading (made effective in October of the same year). Under Rule 10b5-1, the SEC defines insider trading as any securities transaction made when the person behind the trade is aware of nonpublic material information, and is hence violating his or her duty to maintain confidentiality of such knowledge.
Information is defined as being material if its release could affect the company's stock price. The following are examples of material information: the announcement that the company will receive a tender offer, the declaration of a merger, a positive earnings announcement, the release of the company's discovery such as a new drug, an upcoming dividend announcement, an unreleased buy recommendation by an analyst and finally, an imminent exclusive in a financial news column.
http://www.investopedia.com/articles/03/100803.asp#ixzz3hDklJHYM
Their stake is in finding a cure and/or aid for patients. They are all putting in their time and effort into getting this technology to patients.
"When completing DD here on PMCB it will be said that CIAB (Cell in a box) is a new revolutionary technology. It is NOT!! It's 20 years old and all test results PMCB talks about are OLD tests of (NovaCaps)!"
So, "20 years old" is not a reference to time? That does not make any sense at all. Of course stating that "It is not (revolutionary)...It's 20 years old...and all test results old..." is a reference to time. Being revolutionary has nothing to do with how old something is, it means to "cause a change".
http://investorshub.advfn.com/boards/manage_msg.asp?message_id=115719176
The definition of revolutionary has nothing to do with how long something has been around. Revolutionary is defined as "causing a great or complete change".
Cell in a Box(R) technology has the potential to do just that...
For example, if a Type 1 Diabetic no longer has to take insulin daily, that is revolutionary!
Now it can be said that it has not been done yet, but to say it won't be done is only one person's opinion. I know quite a few well-renowned medical professionals who would disagree with that opinion. They all have a lot at stake and are working diligently to bring this revolutionary technology to market.
$PMCB Enjoy Discovery Channel Video
Cell in a Box(R) technology today...
The first indication of passing a test is moving to the next step. Results were reported by the company as positive and now we are moving to human trials.
And the fact that we will be treating for pain associated with pancreatic cancer and malignant ascites for all abdominal cancers is very significant. If you want to hear actual results on what matters, human trials, you should come back in about a year. Otherwise, you will be just complaining day in and out for a long time when it is evident results will take time.
“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
Everything is a process, fros. Sometimes you just have to wait. The processes that bios have are really time intensive. Having concerns just because it takes a long time is unwarranted. Just like anything biological, it happens when its ready, not when we are ready for it to happen.
The work with Dr Von Hoff for pain and malignant ascites is new territory. So is our work with diabetes and Melligen Cells as well as creating a diabetes consortium.
The only work we had done in the past with Cell in a Box was pancreatic cancer. Everything else is new. That is why we are conducting preclinical studies in these three areas with human trials to commence this year for pain and ascites. In fact, there is no treatment any where in the industry for pain associated with pancreatic cancer or malignant ascites for all abdominal cancers. New territory in the field of medicine. Revolutionary...
Q: Can you describe some of the major milestones you’ve been able to accomplish since coming on board?
KENNETH:
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.pharmacytebiotech.com/qa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction/
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.
Lots of buying interest on a Friday. I wonder what's up?
Sounds like we decided on ifosfomide. Now just working on "fine tuning" the treatment. Nice...
What just happened? Look at those bids!
I personally don't think we were denied with this most recent application. Most likely we withdrew our application and will reapply at a future date.
I am not concerned about the withdrawal, if that is what happened. I think we are focusing right where we need to be focused right now.
We have three trials coming up this year, one of them will be a multicentered approach, Phase 2B. Our CRO, Clinical Network Services, is based in Australia so I would not be surprised to hear news about reapplication with the EMA and TGA before the end of the year.
The show isn't over yet fros...
It is really difficult to answer that question unless you have experience with GMP compliance.
However, here are a few of my thoughts. This is Austrianova's first time building their own GMP facility. Whenever a venture is in new territory, lessons have to be learned. We may have needed equipment or other things that were not anticipated. Additional costs may slow things down. Also, when we originally anticipated having GMP approval by the end of 2014, we were not working with a U.S. entity. Once we started working with Dr Von Hoff, the FDA got involved. Seeing that the facility is in Thailand, there may be additional steps to getting approval through all agencies. There may be other possible reasons that I missed and I am hardly an expert. :)
However, the good news is, we are still on track for trials to begin at the end of 3q so it does not appear that we believe we are in jeapordy of not getting approval.
Very important information Pete. Thank you...
To ignore reality and focus only on possible pitfalls is also crazy.
We have worked with other GMP facilities that have stored CiaB in the past so there is no reason to think we won't get GMP for our Thailand facility. We have a full blown team of highly esteemed medical professionals who want to work with this technology and have witnessed its potential for revolutionary treatment. We have a diabetes consortium to help bring treatment to market faster. We have an ATM of cash available for expenses through Chardan.
All factual information. It is just a matter of perspective.... Some hope to see this fail and others hope for its success.
I agree, nothing hidden here, everything is evident, including the fact that this technology is being backed by some of the most successful oncologists in the world.
Once a major milestone is achieved, those institutional investors that have us on watch will buy in big and others will follow. There is no stopping this train. We are gaining momentum, in fact. I am just as confident as our Medical Teams and CEO that we will accomplish our objectives.
There are no real institutional investors at this point and they are likely waiting for some key milestones like recent human trial results, FDA approval/fast tracking, and possibly even GMP approval. But that's how fast the value can change when you've got the right infrastructure, which we are in the process of building methodically.
The pps is what it is because the market is not fully aware of the potential of this technology, but there are quite a few medical professionals who are aware and they will be helping us get this to market awareness.
Do not be misguided....
Very nice post, Bio....
"Dr. Hidalgo is also a co-founder and Chairman of the international Pancreatic Cancer Research Team (PCRT), and works with co-founder Dr. Daniel Von Hoff, who also serves as the Chief Development Officer of Translational Drug Development or TD2. "
Signs are everywhere... Dr Hidalgo has been working with the PCRT at TD2 and Dr Von Hoff during our preclinical trials. Dr Von Hoff approached KW to test additional uses for Cell in a Box(R) technology, results have been reported as being good and now, we have someone associated with Dr Von Hoff on our SAB
“Games are won by players who focus on the playing field –- not by those whose eyes are glued to the scoreboard.”
Warren Buffett
The stars are aligning very well, IMO: Doctors Gunzburg, Crabtree, Salmons, Lohr, Von Hoff and now Dr. Hidalgo. Really adding up to be an ALL STAR team with the big hitter Cell in a Box(R) technology at the helm of treating diabetes, pain, malignant ascites, pancreatic and all abdominal cancers.
And all this for a treatment that has already been proven. The probability of the value of this technology being realized is very high, IMO.
http://www.pharmacytebiotech.com/pancreatic-cancer/
Ken Waggoner, our CEO....
The Benefits Of Establishing A Consortium For Drug R&D
By Kenneth L. Waggoner, Chief Executive Officer, President, General Counsel and Chairman of the Board, PharmaCyte Biotech
Scientific research is a cooperative enterprise. Researchers working today are standing on the shoulders of those who have gone before, and they are paving the way from the next generation of scientists. Today's researchers attend conferences and exchange ideas in a collaborative effort to solve the puzzles of nature. Commercializing medical treatments and profiting from discoveries is much more competitive, sometimes inhibiting further research into a disease because of the need to monetize intellectual property.
Another hurdle to overcome in medical research is simply the vast amount of work being done around the world. Although there has been a revolution in communications in the last couple of decades, it doesn't always follow that we communicate as well as we can or as well as we should. Today, researchers in Japan, Switzerland, and America who are working on complementary projects can, in theory, pick up a phone, send emails, text, tweet and video chat to pick each other’s' brains, share insights, and report findings. But do they do this as effectively and efficiently as possible? Sadly, the answer is no. Often, researchers are unaware of studies others are undertaking that might benefit their own work.
To overcome the tension between research and commercialization and to manage the vast amounts of data being generated, those engaged in bio-technology often form a consortium to address a specific disease. The function of these consortia is to provide a more integrated approach to research and thereby speed treatments to patients.
For example, the Lupus Clinical Trials Consortium was established in 2002 “to support the process of getting promising new therapies for lupus tested and into the marketplace.” The Lupus Clinical Trials Consortium has over 20 academic institutions which receive infrastructure support grants to support readiness for testing new lupus therapies. The Lupus Clinical Trials Consortium is not a clinical trial sponsor, contract research organization, site management organization, or similar entity. The Lupus Clinical Trials Consortium does not participate in the conduct of clinical trials.” It is a charitable, tax exempt organization under Section 501(c)(3) of the Internal Revenue Code.
For prostate cancer, The Prostate Cancer Clinical Trials Consortium (PCCTC) is a 13-member clinical research group sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research Program (PCRP), with its Coordinating Center headquartered at Memorial Sloan Kettering Cancer Center.” The “members of the PCCTC work together on a single mission: to design, implement, and complete hypothesis-driven Phase 1 and Phase 2 trials in prostate cancer, translating scientific discoveries to improved standards of care for patients.”
For private sector participants, the Biomarkers Consortium is a good example. A recent press release on developments in antibiotics that rely on biomarkers noted, “Scientific and financial contributions in support of this project have been provided by Actelion Pharmaceuticals, AstraZeneca, Basilea Pharmaceutica International, Cempra Pharmaceuticals, Cerexa, a wholly-owned subsidiary of Forest Laboratories, Cubist Pharmaceuticals, Merck, Nabriva Therapeutics and Trius Therapeutics. Clinical trial data were also contributed to the collaboration by Cerexa and Cubist, as well as by Durata Therapeutics and Pfizer.”
My company, PharmaCyte Biotech, is 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. We were looking at our research schedule, and it seemed like we would be able to get our treatment for diabetes into clinic trials no sooner than 2020. That just wasn't good enough. Although we aren't Pfizer or AstraZeneca, I thought that a consortium approach to our research could improve that time-frame. So, we formed our International Diabetes Consortium. Now, thanks to this approach, our treatment may be in clinical trials by 2016.
Challenges And Opportunities
Recruitment: The toughest part of establishing a consortium is recruiting the right people. To succeed at this, three things must happen. First, you have to identify among the best researchers pursuing the most promising therapies. Second, you have to demonstrate that the consortium will improve their research capacity without undermining the originality of their work—help them break out of the silos. Third, leaders and coordinators of research have to have the support of the entire membership; internal bickering and fiefdom building has to be considered out of bounds.
Relations With Research Institutions: In most instances, you will have a relationship with the research institution for which your recruits work. This is preferred because all the legal, financial, and other complications have been settled already. In cases where you don't, you will have to sign deals to handle these things. However, if you have an eager recruit, you also have an eager internal salesperson pushing for an agreement.
Mechanics For Sharing: In the bad old days before the Internet, clearinghouse functions probably worked against creating a consortium. Now, electronic exchange of data by e-mail, Dropbox, or other file sharing methods makes it vastly simpler. You just need one person, and usually it’s the researcher who volunteers to coordinate the exchange.
Costs: What is most amazing is that the cost of forming a consortium is negligible. Since the researchers are already being paid by their institutions, you don't need a secretariat of any size (administration is usually a small chore as part of a person's working day). Computerization and the Internet have also more or less eliminated costs.
Benefits: A consortium can do two things that need doing: First, it can reduce the amount of time research takes meaning that treatments get to patients faster. Second, it encourages the exchange of ideas that can lead to new concepts and approaches. The intellectual cross-pollination is difficult to measure, but it is clearly there every time a scientist says “Why didn't I think of that before?” Those moments are frequent for the members of our International Diabetes Consortium.
Obviously, the expertise and scientific principles required remain the same. Ultimately, what we are proposing here is not so much a shift in the scientific research, but rather that there is a much better way of managing the information flow among researchers in pursuit of a common goal.
Kenneth L. Waggoner has almost four decades of experience in management, business, operations and law. Mr. Waggoner started his career as an attorney in private practice. Notably he was a senior partner with Brobeck, Phleger, and Harrison, named one of the top two law firms worldwide that provide services to biotechnology clients including Chiron, Amgen, Biogen Idec, Sangamo, Ligand, DepoTech, and many others. He was the Managing Partner of Brobeck’s Los Angeles office. Mr. Waggoner was also a member of the Executive Committee for almost ten years and on the Policy Committee for numerous years managing Brobeck’s worldwide operations with annual revenues in excess of $750,000,000. While at Brobeck, Mr. Waggoner was the Co-Chairman of Brobeck’s world-wide Environmental Law Group. Mr. Waggoner received his Juris Doctorate with honors in 1973 from Loyola University School of Law in Los Angeles.