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LOOKS LIKE PHARMACYTE BIOTECH ACQUIRING THE WORLD WIDE RIGHTS TO CELL IN A BOX WAS ON THE RIGHT TRACK ALL ALONG
LOOKS LIKE CELL IN A BOX HAS BEEN ON THE RIGHT TRACK ALL ALONG
Prof. Hans-Peter Hammes, M.D.
“I am very much looking forward to contribute to this exciting field on which so many patients with type 1 diabetes put a lot of hope. Since the early days of clinical training by Konrad Federlin, islet replacement therapy was on the agenda, and the prevention of diabetic microvascular complications by islet transplantation was among my earliest experimental studies.”
but then that is why us longs bought in the first place...we were able to vision what the right track was...
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PharmaCyte Biotech Appoints International Diabetes Expert to Its Scientific Advisory Board
SILVER SPRING, Md., Nov. 19, 2015 (GLOBE NEWSWIRE) -- 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®, announced today that Prof. Hans-Peter Hammes, M.D., has accepted an appointment to PharmaCyte’s Scientific Advisory Board. Prof. Hammes is recognized internationally as a preeminent figure in the treatment of diabetes and its complications. In addition to his appointment to the Board, Prof. Hammes has agreed to become a member of PharmaCyte’s international Diabetes Consortium and to serve as a consultant to PharmaCyte.
The Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner, commented, “We are honored that Prof. Hammes has agreed to join our Scientific Advisory Board and to serve as a consultant to the company. Prof. Hammes is one of Europe’s leading authorities in all aspects of diabetes and is well versed on the types of studies that will be needed to develop an effective treatment for the disease. It is indeed a privilege to have him join our team. Prof. Hammes’ enthusiasm for the work being done by the international Diabetes Consortium was shown by his active participation at this year’s annual meeting of the Consortium recently held in Vienna, Austria. Every member of the Consortium felt that Prof. Hammes’ contributions were invaluable. Prof. Hammes has already demonstrated he is going to be a major resource to Pharmacyte, as we develop our treatment for insulin-dependent diabetes.”
Prof. Hans-Peter Hammes, M.D., is a Professor of Internal Medicine and Endocrinology at the University Medical Center Mannheim, University of Heidelberg, Germany. Prof. Hammes received his medical degree from Westfälische Wilhelm-University in Münster, Germany. Since graduating in 1980, Prof. Hammes has held several positions in the field of diabetes, with emphasis on the biochemistry of diabetic complications, diabetic retinopathy, angiogenesis and predictors of vascular complication from diabetes. Prof. Hammes is recognized worldwide for his work on the retinopathy (damage to the eyes) that can result from diabetes.
Prof. Hammes was trained in diabetes by the one of the world’s most recognized authorities on the treatment of diabetes, Prof. Konrad Federlin, at the University of Giessen, Germany. In 1996, Prof. Hammes was named “Diabetologist” by the German Diabetes Association. Prof. Hammes is a member of several professional organizations, including the German Society of Internal Medicine, the German Society of Endocrinology and the European Association for the Study of Diabetes (EASD). Prof. Hammes was this year’s recipient of the prestigious Camillo Golgi Prize awarded by EASD at its annual meeting. He has co-authored over 200 scientific articles and books involving diabetes.
“I am very much looking forward to contribute to this exciting field on which so many patients with type 1 diabetes put a lot of hope. Since the early days of clinical training by Konrad Federlin, islet replacement therapy was on the agenda, and the prevention of diabetic microvascular complications by islet transplantation was among my earliest experimental studies.”
PMCB HEADED INTO A PANCREATIC CANCER HUMAN TRIAL SOON...
NOT TO MENTION CIAB FOR DIABETES...WITH A CONSORTIUM OF WORLD RENOWNED DOCTORS...
bull
Best for the small educated knowledgeable investor to BUY this PMCB before PMCB IS BOUGHT OUT...
you see I don't look at the small retail investor as being ignorant like some people do....
good luck to you on your TRADE...
bull
PMCB JUST RECEIVED ORPHAN DRUG DESIGNATION FROM THE EMA JUST LIKE THEY DID FROM THE FDA...
Best to BUY this PMCB...
bull
PMCB WILL GET cGMP JUST LIKE THEY GOT ODD FROM BOTH THE FDA AND THE EMA...
I would think a couple of people might be getting tired of being wrong about PMCB...
bull
There is a lot of information on PharmaCyte Biotech web site...a lot of due diligence can be done there and if you just google Cell in a Box you will find a lot...it is best to do your own due diligence when you buy a stock so that you get your information from the horses mouth...
ODD is Orphan Drug Designation...and I too believe we already have it...we would not have to go back through the meeting process...EMA just like the FDA is set up to help companies achieve ODD if they need some more information from them...
and those who want to deny it will be embarrassed when it's officially announced...
bull
For Pharmacyte Biotech, It's Not Even a Fair Fight (in a good way for PMCB)
Pharmacyte Biotech Inc. (OTCMKTS:PMCB) has the biotech industry's equivalent of Superman working in its corner.
How does the old saying from the world of business go? It's not what you know, buy who you know? If it's true (and it is), then Pharmacyte Biotech Inc. (OTCMKTS:PMCB) should be proud - and PMCB investors should be excited - about this week's news regarding the company's team member that's largely leading the company's development of a novel pancreatic cancer therapy.
For those investors that know Pharmacyte Biotech well, the name Manuel Hidalgo will certainly ring a bell. He's the gentlemen who was added to the company's Scientific Advisory Board in July, bringing with him a relevant curriculum vitae that's not only a bit of a show-stopper, but a dossier that doesn't even seem quite fair to the companies that will have to compete with Pharmacyte Biotech pancreatic cancer treatment.
Dr. Hidalgo is a co-founder and Chairman of the international Pancreatic Cancer Research Team (PCRT) along with co-founder Dr. Daniel Von Hoff, and is (or was, anyway - more on this in a moment) the Chief Development Officer of Translational Drug Development. The PCRT is a group of preeminent researchers dedicated to organizing and accelerating the clinical development of new agents for the treatment of patients with pancreatic cancer. Dr. Hidalgo has participated in the clinical development of more than 30 novel anticancer agents, including studies for the current gold standard for the treatment of advanced pancreatic cancer, the combination chemotherapy of gemcitabine and Abraxane(r). Dr. Hidalgo also led the early clinical trials of temsirolimus (Torisel(tm)), approved for use against advanced kidney cancer, and erlotinib (Tarceva(r)), approved for use against advanced non-small cell lung cancer as well against advanced pancreatic cancer when used in combination with gemcitabine.
That work history is significant.... especially the part about "has participated in the clinical development of more than 30 novel anticancer agents, including studies for the current gold standard for the treatment of advanced pancreatic cancer, the combination chemotherapy of gemcitabine and Abraxane." It matters, because those are the therapies PMCB will find on the playing field as it initiates its newly-redesigned Phase 2b study of Cell-in-a-Box delivery of ifosfamide. ... a redesign that was largely encouraged by Hidalgo after looking closely at the phase 1 results. The new direction will employ the company's Cell-in-a-Box technology as a means to treat a mostly unmet need within the realm of pancreatic cancer patients.
That's because Dr. Hidalgo is the kind of authority that, when he speaks, people listen.
Fast forward to today. Per this week's announcement, Manuel Hidalgo has been named as the Clinical Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center, part of the Cancer Center at the Beth Israel Deaconess Medical Center (BIDMC) in Boston. Dr. Hidalgo has also been appointed Chief of the hospital's Division of Hematology-Oncology. In his role at the prestigious medical center, Dr. Hidalgo will oversee all of BIDMC's clinical cancer programs. He's still on the Pharmacyte Biotech Scientific Advisory Board, though, and will still be offering his valuable expertise to that end.
It's about as much credibility as any one person or any one company should be allowed to have, and speaks volumes about the caliber and potential of the PMCB pancreatic cancer R&D.
PMCB ACTUALLY UP TODAY...0.10250.0016 (1.59%)...
not the definition of tanking I know...
good luck with your TRADE...
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PMCB closed around the same pps as it has been...
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ANOTHER ARTICLE ON HIDALGO...
BIDMC Names Manuel Hidalgo, MD, PhD, Clinical Director of the Cancer Center and Chief of Hematology-Oncology
International leader in pancreatic cancer research and treatment
Date: 10/14/2015
BIDMC Contact: Jennifer Kritz
Phone: 617-667-7301
Email: jkritz@bidmc.harvard.edu
http://www.bidmc.org/News/In-Medicine/2015/October/Hidalgo.aspx
PMCB...GETTING BETTER AND BETTER...
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PMCB..GETTING BETTER AND BETTER ALL THE TIME...
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PharmaCyte Biotech Scientific Advisory Board Member Named Clinical Director of Prestigious Boston Cancer Center
SILVER SPRING, Md., Nov. 10, 2015 (GLOBE NEWSWIRE) -- 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®, announced today that Manuel Hidalgo, MD, PhD, an internationally respected oncologist and a member of PharmaCyte ’s Scientific Advisory Board, has been named Clinical Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center, part of the Cancer Center at the Beth Israel Deaconess Medical Center (BIDMC) in Boston. Dr. Hidalgo has also been appointed Chief of the hospital’s Division of Hematology-Oncology. In his role at the prestigious medical center, Dr. Hidalgo will oversee all of BIDMC’s clinical cancer programs.
Dr. Hidalgo, whose groundbreaking work in experimental cancer therapy and tumor model development has led to key advances in the treatment of pancreatic cancer, will join the BIDMC this month. He is currently serving as the Director of the Clinical Research Program and Vice Director of Translational Research at the Spanish National Cancer Center. Dr. Hidalgo also holds faculty positions at University CEU San Pablo and Johns Hopkins University.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, commented “We would like to offer Dr. Hidalgo our sincerest congratulations on his appointment at such a well-recognized center of excellence as the BIDMC. We are sure that his expertise in treating pancreatic and other solid tumors will be a great addition to the talent already at the Cancer Center of the BIDMC and, most importantly, will help ensure that patients treated at the Cancer Center receive the best and most up-to-date treatments possible for their disease.”
The BIDMC Cancer Center consists of multiple disciplines, including medical oncology, surgical oncology, radiation oncology, radiology and pathology. Twenty-one specialty patient-care programs focus on pancreatic cancer, bone-marrow transplants, breast cancer, prostate cancer and biologic therapy, among others. The Cancer Center, with 160 faculty members and more than $70 million in annual research support, is also home to the Cancer Clinical Trials Office, where hundreds of clinical trials provide patients with access to promising new therapies. The BIDMC is a founding member of the Dana-Farber/Harvard Cancer Center.
The BIDMC is a patient care, teaching and research affiliate of the Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. The BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of the Dana-Farber/Harvard Cancer Center and The Jackson Laboratory.
What do you think a Shelf Offering is lol....it was filed with an amount...they can sell what they want when they want all the way up to that amount...
hmm...we all seem to know that...
maybe this will help you....
http://media.mofo.com/files/Uploads/Images/FAQShelfOfferings.pdf
good luck with your TRADE...
bull
Don't get caught up in Fisher sylvia...us longs even as individuals own a lot more shares then they do...they don't mean anything...you will not see institutions buying into a stock at this price on the OTC...most won't even touch a stock under 5 dollars...
we own this stock for the buyout...bottom line...
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To be honest probably not...don't get caught up in the OS with this stock...this is a tiny R&D bio on the OTC that has amazing technology that they bought out right world wide rights...
If you know about tiny bios ....they are not meant to take a drug or in this case a drug delivery encapsulation therapy to market...these small bios raise money usually the only way they can by selling shares...
It won't matter...this has never been a stock for us longs that we expected to go real high UNTIL we get into trials...even then we are all in because we had the vision to know this is a BUYOUT stock...it isn't and then one day it is...
And the upcoming trial and ESPECIALLY the CiaB for Diabetes where the real money is...that is what we bought and wait for...
do your DD...but not on here...
good luck and hope you have vision of this amazing company like we do...
bull
NO ONE has to worry about a contract with PharmaCyte and Ken Waggoner with ALL THAT HE HAS ACCOMPLISHED IN 2 YEARS...
but I guess some do lol...good luck with your TRADE..
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Where are you getting your information from???...I know not ONE LONG that knows Cell in a Box is NOT new technology...PMCB bought world wide rights to Ciab from a company that did not have the money to develop it or the know how to find the money to develop it because they were not business men...they were doctors and scientists...
please do more DD before making blanket statements that are incorrect...it misleads people...
good luck though on your TRADE...
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PharmaCyte Biotech (NVLX) Finalizes International Diabetes Consortium To Cure Diabetes
4/20/2015 10:33:41 AM
SILVER SPRING, Md., April 20, 2015 (GLOBE NEWSWIRE) -- 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 world class team of scientists, physicians and academics that make up its international Diabetes Consortium is now complete with the addition of the final two members, Dr. Thomas Stratmann and Dr. Axel Kornerup Hansen.
Dr. Stratmann is an Associate Professor at the Department of Physiology and Immunology in the Faculty of Biology at the University of Barcelona in Spain. Dr. Stratmann has extensive experience in using a diabetes mouse model of Type 1 diabetes in which the disease develops rapidly in contrast to other mouse models where the disease only develops after several weeks. Through the use of this model as the Consortium progresses in its animal preclinical studies with Cell-in-a-Box®-encapsulated Melligen cells, it is fully expected that the overall development timeline for PharmaCyte Biotech's diabetes treatment will be shortened significantly.
Dr. Kornerup Hansen is a Professor in the Department of Veterinary Disease Biology at the University of Copenhagen in Denmark. He will perform specially designed preclinical studies to determine the minimum dose of encapsulated Melligen cells that will normalize blood glucose levels in diabetic rats as well as pigs, which are an important model for mimicking the dosing that will be required for human patients.
PharmaCyte Biotech has the exclusive worldwide rights to use the Melligen cells to treat diabetes. Melligen cells are genetically engineered from human liver cells and have been shown to secrete insulin in response to the concentrations of glucose (blood sugar) in their environment. When Melligen cells were transplanted into diabetic mice whose immune systems were essentially not functioning, the blood glucose levels of the mice became normal. This observation illustrates that Melligen cells can reverse the diabetic condition.
PharmaCyte Biotech's CEO, Kenneth L. Waggoner, said of the 16-member Diabetes Consortium, "We are very pleased that our international Diabetes Consortium is now complete after only a few months of development. We feel that the scientists, physicians and academics that make up our Consortium are of the highest caliber and have already proven that they can work in concert as the development of our diabetes treatment progresses. We firmly believe that, although the members within the Consortium are diverse in terms of their geographic location and expertise, their talents and knowledge are most complementary. Because of this, PharmaCyte Biotech's treatment for insulin-dependent diabetes could be in clinical testing much sooner than would otherwise be the case."
PharmaCyte Biotech's Diabetes Consortium brings together a global coalition of world class experts from various universities and institutions in several countries around the world. All members of the Consortium are committed to developing a treatment for insulin-dependent diabetes using PharmaCyte Biotech's Cell-in-a-Box® cellulose-based live-cell encapsulation technology combined with human non-pancreatic, insulin-producing cells (Melligen Cells).
Members of the Diabetes Consortium have all agreed to bring their expertise to the Consortium and work in concert to develop a treatment for diabetes. In view of the considerable collective experience and through their collaborative efforts, the timeline for the development of PharmaCyte Biotech's diabetes treatment will be significantly shortened. The members of the Consortium and their expected contributions are:
Dr. Eva-Maria Brandtner, Head of the Bioencapsulation Unit at the Vorarlberg Institute for Vascular Investigation and TreatmentProgram Development for the Consortium. Dr. Brandtner will coordinate all of the Diabetes Consortium's research activities and also have a scientific advisory role. Dr. Brandtner previously served as Chief Scientist at Austrianova where she conducted studies related to the encapsulation of Melligen Cells and the early testing of their use in PharmaCyte Biotech's encapsulation technology as a treatment for diabetes. Dr. Brandtner serves as PharmaCyte Biotech's Director of Diabetes Program Development and is a consultant to PharmaCyte Biotech.
Dr. Matthias Löhr, Professor of Gastroenterology and Hepatology at the Karolinska Institute in Stockholm, Sweden, will serve a pivotal scientific advisory role for the Diabetes Consortium. Dr. Löhr is exceedingly familiar with the Cell-in-a-Box® technology having served as Principal Investigator for the clinical trials in pancreatic cancer that employed the technology together with the cancer chemotherapy drug ifosfamide. In addition to pancreatic cancer, Dr. Löhr has a specialty in diabetes and its treatment and believes that the Cell-in-a-Box® technology will provide a platform upon which effective treatments for both pancreatic cancer and diabetes can be built. Dr. Löhr is a consultant to PharmaCyte Biotech and the Chairman of PharmaCyte Biotech's Scientific Advisory Board.
Prof. Walter H. Günzburg, Dr. Brian SalmonsandDr. John Dangerfield of Austrianova will all play significant scientific advisory roles. Prof. Günzburg is Chief Technical Officer of Austrianova and serves as PharmaCyte Biotech's Chief Scientific Officer. He is also Professor of Virology at the University of Veterinary Medicine in Vienna (VetMed). Dr. Salmons is the CEO and President of Austrianova and is a member of the Scientific Advisory Board of PharmaCyte Biotech. Prof. Günzburg and Dr. Salmons co-developed the Cell-in-a-Box® technology and thus are the world's experts in its potential use for the treatment of diseases. Both are also consultants to PharmaCyte Biotech. Dr. Dangerfield, the COO of Austrianova, is intimately involved in dealing with the Cell-in-a-Box® encapsulation process on a daily basis. All three will be responsible for the preparation of cells and their encapsulation as required for preclinical studies and ultimately be involved in human clinical trials as the Diabetes Consortium develops its diabetes treatment.
Prof. Ann Simpson and Dr. Brenton Hamdorf of the University of Technology in Sydney (UTS), Australia, and their scientific colleagues at UTS are essential to the success of the efforts of the Diabetes Consortium. Dr. Simpson, Professor of Biochemistry at UTS, has spent a significant portion of her professional career in developing and characterizing the non-pancreatic insulin-producing Melligen Cells that will be encapsulated using the Cell-in-a-Box® technology to produce PharmaCyte Biotech's treatment for insulin-dependent diabetes. Prof. Simpson serves as a consultant to PharmaCyte Biotech. Dr. Hamdorf serves as UTS' business development contact and partner for the Diabetes Consortium. Dr. Simpson and her fellow scientists at UTS will be responsible for performing laboratory and animal studies on the Melligen Cells both before and after encapsulation that will be necessary for defining the parameters under which the Melligen Cells produce insulin.
Dr. Constantine Konstantoulas and Mag Helga Petznek (veterinarian) of VetMed will be responsible for conducting animal studies with encapsulated Melligen Cells that will test the potential of these cells to produce tumors, define the biocompatibility of the encapsulated Melligen Cells and test the ability of the encapsulated cells to produce insulin in a mouse model in which Type 1 diabetes has been induced by the introduction of a virus. Dr. Konstantoulas will coordinate the day-to-day activities of these tests, and Prof. Walter H. Günzburg will oversee all of the studies done at VetMed. The studies at this institution are already underway.
Dr. Thomas Stratmann, Associate Professor at the Department of Physiology and Immunology in the Faculty of Biology at the University of Barcelona in Spain, has extensive experience in using a diabetes mouse model of Type 1 diabetes in which the disease develops rapidly. Through the use of this model, as the Diabetes Consortium progresses in its animal preclinical studies with Cell-in-a-Box®-encapsulated Melligen Cells, it is fully expected that the overall development timeline for PharmaCyte Biotech's diabetes treatment will be considerably shortened. In addition, Dr. Stratmann has two other mouse models of Type 1 diabetes in his laboratory. Through the use of these other animal models, and in combination with other test systems, the Consortium should be able to obtain irrefutable data as to the effectiveness of PharmaCyte Biotech's diabetes treatment.
Prof. Axel Kornerup Hansen, Professor in the Department of Veterinary Disease Biology at the University of Copenhagen in Denmark, will perform preclinical studies to determine the minimum dose of encapsulated Melligen Cells that will normalize blood glucose levels in diabetic rats. In addition, Dr. Hansen will perform the same tests on pigs that have been made diabetic by injecting them with a drug known as streptozotocin. This drug destroys the ability of the pancreas to produce insulin and thus results in diabetes.
Dr. Andreas Blutke, Dr. Rüdiger Wanke, and Dr. Eckhard Wolf, of the Laboratory of Functional Genome Analysis, Gene Center, at the Ludwig-Maximillians University in Munich, Germany, have developed unique transgenic mouse and pig models in which the mice and pigs exhibit diabetes from birth without the use of diabetes-inducing drugs. When these models are ready, they will be used by the Diabetes Consortium to test the effectives of PharmaCyte Biotech's diabetes treatment and to study the effectiveness of the treatment in minimizing the kidney and pancreas alterations that occur as diabetes progresses.
Kenneth L. Waggoner, JD and Dr. Gerald W. Crabtree, the CEO and the COO, respectively, of PharmaCyte Biotech will be responsible for providing overall coordination and management of the Diabetes Consortium as well as and funding for the activities within the Consortium. PharmaCyte Biotech will also provide scientific direction and support when it is required.
NEWS FOR PMCB LOOKS GREAT...
no long here is going to be (what did you call it... dumping) any of their stock right before we get IND and go into the Pancreatic Trial now being done in the USA and overseen by world renown doctors... and going to the FDA for approval in what could take a little over a year now...
only the traders are dumping as usual...
and anyone who has invested in a lot of bios like me knows that these R&D small bios that have something especially like CiaB...do not take their development to fruition because they get bought out or get a partner...
but good luck to you with your TRADE...
bull
If we can beat them join them...CiaB upon approval with the FDA will become a part of the FIRST LINE THERAPY for all Pancreatic Cancer patients...
what is not to like about that?
bull
That's how smart PMCB was...and the Pancreatic Trial we are about to start with the results going to the FDA for approval at the end of it will be proof...and the time for that has now been moved up with moving the trial to the USA...could be right over a year...hmm
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"Yet no one but pmcb thought it was worth anything."
someone will be eating these words soon...
HENCE the new mouse studies PharmaCyte has been conducting...and the new and improved Pancreatic Trial that we are about to start BASED OUT OF THE USA NOW with results going to the FDA for approval at the end of it...proving a couple people dead wrong on here...
but good luck to you anyway...
bull
NOT TRUE...the best treatment wins out whether or not it was first...CiaB for Pancreatic Cancer beat Celgene's therapy from Austrianova's studies years ago...and yes Celgene's Abraxane got approval...(oh yeah and by Dr. Von Hoff) the same Von Hoff involved in our trials...
here is a good example...
http://www.pharmatimes.com/Article/14-09-09/NICE_no_for_Celgene_s_Abraxane_in_pancreatic_cancer.aspx
read the article...
"The National Institute for Health and Care Excellence has published new recommendations rejecting the use of Celgene’s Abraxane (nab-paclitaxel) on the National Health Service to treat patients with advanced pancreatic cancer."
"NICE says that data provided by Celgene show that the chemo regimen FOLFIRINOX, a first-line option for patients with the disease, was actually more clinically effective than the Abraxane/gemcitabine combination. And while Abraxane/gemcitabine was more effective than gemcitabine alone, it resulted in more serious side effects.
CiaB for Diabetes is completely different from the company you posted...
do some more DD on it...
bull
Conference Call...
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We're not going head to head because the need is greater elsewhere and to go head to head in Australia or anywhere would mean difficulties in patient accrual... so much so that it would take years... the company has reduced a clinical trial from 3 to 4 years going head to head to 1 year and potentially can become part of the gold standard of care in a consolidated therapy....
hope this clears things up for you...
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PHARMACYTE'S Pancreatic Cancer Trial administers CiaB the same way as previously...Targeted Therapy..at the location of the tumor...which activates the Ifosfamide at the target sight...so when chemo is put into the port...it is not activated until it reaches the CiaB AT THE TUMOR...so hence the no side effects or minimal side effects...
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in ref. to your remark here...
"For me CIB is counterproductive if you are having to inject it everywhere in the abdominal cavity so a prerequisite for it to be useful is that the cancer cannot have mestasticized by the time CIB is considered for use. "
How many tiny R&D Biotech companies have you been in where the CEO does CC's..
oh my...
bull
You said you were selling in the .20's...how does that fit into your 10 bagger...trader or investor?
PHARMACYTE LONG...ALWAYS WAS...STILL AM...ALWAYS WILL BE...
bull
Just like Bio I am really baffled anymore at the lack of reading comprehension from 2 investors???? on here...
I think everyone else seems to have it down...the fact that the company knows exactly what they are doing and have been getting all their ducks in a row...
PharmaCyte Biotech Discusses Major Milestones Ahead of Phase 2b Clinical Trial in Pancreatic Cancer
September 15, 2015
SILVER SPRING, Md., Sept. 15, 2015 (GLOBE NEWSWIRE) -- 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®, discussed today some of the major “milestone” tasks that must be completed to begin its Phase 2b clinical trial in pancreatic cancer. The trial will test the effectiveness and safety of PharmaCyte Biotech’s pancreatic cancer treatment. This treatment consists of the combination of microcapsules with genetically modified live cells in combination with low doses of the chemotherapy drug ifosfamide. These encapsulated live cells are placed as close to a cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the patient’s cancer.
In the coming weeks and months, a number of major “milestone” tasks will take place that will enable PharmaCyte Biotech’s first clinical trial to commence. Many of these must be completed before a formal Investigational New Drug application (“IND”) is filed with the drug regulatory authorities.
Finalization of Trial Design: With pivotal input from PharmaCyte Biotech’s renowned team of oncologists, the design of its clinical trial will be finalized with the goal of creating the highest probability of developing positive data during the trial that could lead to marketing approval of its treatment for pancreatic cancer.
IND Team: An IND Team will be established to prepare the IND and review it before being formally submitted to the regulatory authorities. PharmaCyte Biotech’s IND Team, many of whom have already been retained, will include: (i) a Project Manager; (ii) a Medical Officer; (iii) a Statistician; (iv) a Chemistry, Manufacturing and Controls Expert; (v) a Pharmacologist; (vi) a Pharmakineticist; (vii) a Toxicologist; (viii) an Interventional Radiologist; (ix) a Radiologist; and (x) a Regulatory Affairs person.
Chemistry, Manufacturing and Controls Information: The manufacturing of investigational biological products are subject to stringent regulatory considerations. PharmaCyte Biotech will be working with Austrianova – the manufacturer of the encapsulated live cells used in PharmaCyte Biotech’s treatment for pancreatic cancer – to develop this information.
Clinical Protocol: A “protocol” will be prepared with by its Contract Research Organization with the invaluable assistance of PharmaCyte Biotech’s team of oncologists. The clinical protocol can be viewed as a “recipe” on how the clinical trial will be conducted. The protocol will include such things as: (i) the qualifications needed for particular patients to be included in the trial; (ii) how PharmaCyte Biotech’s treatment and the treatment used in the “comparator” arm of the study will be administered and the schedule and duration of these treatments; (iii) the specific “endpoints” for the trial and the types of data that will be collected to determine these endpoints; and (iv) the types of data analysis that will be employed in reaching conclusions about the overall success of the trial.
Pre-IND Meeting: This meeting will be requested by PharmaCyte Biotech and initiates communication with the drug regulatory authorities that will be responsible for approving its product to market. This communication is particularly important for a company like PharmaCyte biotech that is developing a new product or technology. The purpose of a pre-IND meeting is to discuss the information that will be used to prepare the IND, such as product characterization, final and in-process testing of the product, previous animal test data, prior clinical trial data and the proposed clinical protocol. Input from the regulatory authorities given during the pre-IND meeting will lead to “fine-tuning” the clinical trial protocol and will identify any additional items that may need to be included in the IND.
Clinical Trial Study Sites: Clinical study sites will be evaluated and enrolled to participate in the clinical trial. Each site will need to be multidisciplinary in nature, where medical oncologists, interventional radiologists, radiologists and other cancer specialists work together to offer multidisciplinary cancer treatments and who will work in concert in conducting their part of the clinical trial.
IND: An Investigational New Drug application will be submitted to the drug regulatory authorities before PharmaCyte Biotech can begin the clinical trial. The IND will include animal study data, toxicity (side effects that cause great harm) data, manufacturing information, the clinical protocol for the trial, data from any prior human clinical trials and information about the Principal Investigator who will oversee all aspects of the trial.
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented on the process underway at the company, “A well thought out clinical trial design and program is critical for the long-term effectiveness of efforts to bring our treatment for pancreatic cancer through the regulatory approval process. Bringing a new cancer therapy through the approval process requires an in depth understanding of the complex drug development process and the integral role that each member of our team plays in that process. Proper planning and addressing the critical steps in the development of that process are essential. Because of our outstanding team of oncologists and our other team members, we believe that we are taking measures to avoid unnecessary expenses and barriers in navigating our treatment to a successful conclusion.”
I for one will go with the experts on this...which is the World Renowned Doctors involved along with the CEO and COO that more than know what they are doing...
PHARMACYTE BIOTECH LONG...ALWAYS WAS...STILL AM...AND ALWAYS WILL BE...
bull
Exactly Bio...I understand that there are new investors to PharmaCyte Biotech but there are also new investors that this is their first biotech...so this audio is invaluable to them to help them understand what they read in the PR...love it...
bull
GREAT NEW AUDIO WITH CEO WAGGONER AND COO CRABTREE EXPLAINING THE NEW TRIAL DESIGN...
http://www.stockmarketmediagroup.com/wp-content/uploads/2015/10/PharmaCyte_Biotech_CEO_Interview.mp3
bull
EMA ODD is just a formality now to get and when we get cGMP...what will you be pounding on next...just curious...
my guess would be the IND's we will be receiving from the FDA and then we are in human trials for our Pancreatic Cancer ...
good luck with all of that though....I'll stay long...
PHARMACYTE BIOTECH LONG...ALWAY WAS...STILL AM...AND ALWAYS WILL BE...
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I answered you...where at all do you see the word ascites in today's Pr...
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The Pancreatic Cancer Clinical Trial has nothing to do with ascites...that is a seperate trial on it's own....
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The upcoming Pre-IND Meeting with the FDA with Dr. Von Hoff, Dr. Lohr, Dr. Hidalgo and company officials...
WOW...
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"The trial design also includes several secondary endpoints. Among the most important are: (i) the onset of pain and the patient’s need for pain medications; (ii) whether the inoperable tumors become operable as a result of the treatment; (iii) the change in tumor size; and (iv) the patient’s overall quality of life during the treatment."
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"The primary endpoints will be: (i) progression-free survival; and (ii) the side effects from the treatment that occur in the patients. Progression-free survival (PFS) is the time that elapses from the first day of treatment until the disease gets worse. PFS will be determined at 6 and 12 months. The occurrence of any side effects will be monitored throughout the trial."
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GREAT JOB PHARMACYTE BIOTECH...
I only see 2 distractions on here...they have been here for a while but PMCB is getting ready to roll right over them...
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READ THE NEWS