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PharmaCyte Biotech Clinical Trial Designed to Expand Standard of Care Therapy for Pancreatic Cancer.
SILVER SPRING, Md., Oct. 21, 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 the new trial design for its upcoming clinical trial in patients with advanced pancreatic cancer using PharmaCyte’s treatment (Cell-in-a-Box® + low-dose ifosfamide chemotherapy).
The overall goal of the trial is to determine whether PharmaCyte’s pancreatic cancer treatment can satisfy a critical unmet medical need by acting as a consolidation therapy for patients who no longer respond to the combination of nab-paclitaxel (Abraxane®) + gemcitabine – currently the “gold standard” for the treatment of pancreatic cancer. Treatments for this group of patients are only marginally effective. The trial will compare the effectiveness of PharmaCyte’s pancreatic cancer treatment “head-to-head” using several criteria with one of the commonly used treatments for these patients - the combination of the cancer drug capecitabine (Xeloda®) + x-radiation. Capecitabine, which can be given orally, is a “prodrug” form of the widely used chemotherapeutic agent 5-fluorouracil (5-FU) that is given intravenously.
The trial will be conducted in the United States, with study sites in Europe and Australia. Eligible patients will be randomly placed into two groups. The patients in Group 1 will receive PharmaCyte’s pancreatic cancer treatment. The patients in Group 2 will receive treatment with the combination of capecitabine + x-radiation. Two of the most important factors in the trial design are: (i) the eligibility criteria for accepting patients into the trial; and (ii) the factors to be considered to determine whether PharmaCyte’s treatment has been successful in achieving its goals (endpoints).
Eligibility Criteria: The patients accepted into the trial must have pancreatic cancer that is inoperable, but that has not yet spread from the pancreas where it first started to another place in the body (metastatic cancer). These patients must also have tumors that no longer respond to the combination chemotherapy treatment of Abraxane® + gemcitabine and that have been on the treatment for a period of between four and six months.
Endpoints of the Trial: 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.
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.
The design of the trial was a collaborative effort between PharmaCyte, Translational Drug Development (TD2), America’s premier Contract Research Organization (CRO) specializing in oncology, world renowned oncologists Dr. Mathias Löhr of the famed Karolinska Institute in Stockholm and the Chairman of PharmaCyte’s Scientific Advisory Board, and Dr. Manuel Hidalgo, Director of Clinical Research at the Spanish National Cancer Research Center and a member of PharmaCyte’s Scientific Advisory Board.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the newly designed trial, “The design of our upcoming clinical trial was truly a collaborative effort among world renowned experts in oncology and science. In the trial design, personnel at TD2, Dr. Löhr, Dr. Hidalgo and Dr.Korn at Imaging Endpoints have shown why they have been on the forefront of developing new oncology drugs for advanced pancreatic cancer in innovative ways that can best treat patients with this dreadful disease. By working together as a team, they have accelerated the timeline for getting our pancreatic cancer treatment into the marketplace and have addressed a critical unmet medical need. We could not be more pleased with the trial new design.”
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I see what they are saying about reading comprehension....
SILVER SPRING, Md., Oct. 07, 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, announced today that Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, is currently in Europe ironing out the details that will secure the European Medicines Agency (EMA) Orphan Designation for PharmaCyte Biotech’s pancreatic cancer treatment.
PharmaCyte Biotech’s treatment for advanced pancreatic cancer consists of a unique encapsulation technology known as “Cell-in-a-Box®” in combination with an inactive chemotherapy drug (ifosfamide). The technology encapsulates living cells that have been genetically modified to convert ifosfamide into its active or “cancer-killing” form. The encapsulated cells are first implanted into a patient’s pancreas as close to the tumor as possible. Then ifosfamide is given intravenously as any other chemotherapy agent is, but at one-third the normal dose to eliminate side-effects usually associated with chemotherapy. When the blood carries the ifosfamide to the site of the tumor, activation of the ifosfamide takes place when it comes in contact with the encapsulated live cells - rather than in the liver where it is normally activated.
Waggoner said of his efforts in Europe, “Securing the Orphan Designation in Europe for our pancreatic cancer treatment is vital to our company, as we head into our Phase 2b clinical trial to treat advanced pancreatic cancer. With the Orphan Designation, PharmaCyte Biotech will be provided 10 years of marketing exclusivity throughout Europe for its pancreatic cancer treatment.”
PharmaCyte Biotech will now rely on Clinical Network Services, its Contract Research Organization (CRO) in Australia and Europe, to finalize the documents that will give PharmaCyte Biotech the Orphan Designation with the EMA. Once the European Commission has approved the documents, PharmaCyte Biotech will make an announcement.
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When I read anything from anyone talking about dilution with a tiny R&D bio...it makes me think this is their first bio...
with the exception of someone being a trader which seems to be the case here...
we are a R&D not a big bio or a big pharma...we are exactly where we are supposed to be...
we are not meant to take anything to market...we are meant to develop it for a huge pharma to take it to fruition...dilution talk is ridiculous with this stock...
no offense...
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PharmaCyte Biotech’s Cell Encapsulation Technology at the Forefront of Future Diabetes Treatments
Juvenile Diabetes Research Foundation Recognizes Cell Encapsulation as a Viable Treatment for Type 1 Diabetes
Diabetes is a disease that directly affects millions and indirectly affects nearly every family in America today and tens of millions of sufferers abroad. Thus, it is no surprise that Transparency Market Research, in a report entitled ‘Global Diabetes Devices Market and Diabetes Drugs Market – Industry Scenario, Trends, Analysis, Size, Share and Forecast, 2011 - 2018,’ projects that the global diabetes market for therapeutic devices and drugs is expected to reach US $114.3 billion by 2018.
Following decades of failed research, a great deal of attention and funding have recently turned toward utilizing encapsulation techniques to treat Type 1 diabetes (T1D), including the approach championed by PharmaCyte Biotech (OTCQB – PMCB - $0.1152 – Spec Buy), which in turn, is likely to drive clinical and investor interest in the Company.
With over $200 million in assets, the Juvenile Diabetes Research Foundation (JDRF) is the leading research organization focused on T1D research. For the uninitiated, T1D is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. The JDRF is helping fund what are deemed as two promising clinical trials using varied encapsulation techniques involving the implantation of cells encapsulated in a material known as alginate, a derivative of seaweed.
The potential stumbling block with these trials is that according to most studies, over time the body’s immune system attacks the alginate, impairing the ability of the cells encapsulated inside the alginate to achieve their objective. Conversely, PharmaCyte Biotech uses a cellulose-based encapsulation technology, Cell-in-a-Box®,, which uses a bio-inert, non-toxic, biocompatible material to make pin-head sized capsules that protect the encapsulated cells from attack by the body's defense mechanisms. At the same time, the capsules provide a microenvironment that enables encapsulated cells to survive for long periods of time, which is a major advantage over other encapsulation technologies, such as those using alginate.
As a result, PharmaCyte Biotech’s Cell-in-a-Box®-based treatment system approach could not only emerge as the superior encapsulation technique used to treat T1D, but it could attract the attention of the JDRF and other major diabetes research sponsors.
The Company has the exclusive worldwide rights to use 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. A recent article published in scientific journal Molecular Therapy noted that 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. Therefore, the Melligen cell line, when combined with Cell-in-a-Box® encapsulation, could ultimately become a treatment that has clear advantages over current therapies used for Type 1 diabetes, and could potentially replace them.
With the high-profile shift toward the utilization of encapsulation techniques to treat T1D in research studies taking center stage, and with PharmaCyte Biotech’s own encapsulation system/Melligen preclinical studies in the offing, the value of the Company’s technology to treat this far-reaching disease is primed to receive a boost.
http://www.goldmanresearch.com/201510201048/Opportunity-Research/pharmacyte-biotechs-cell-encapsulation-technology-at-the-forefront-of-future-diabetes-treatments.html
Seems to me there are only 2 sources on here worried about Pharmacyte Biotech....I am glad I am not either of them up posting at 3 a.m.
Pharmacyte Biotech LONG...always was...am today...and always will be...
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PharmaCyte Biotech to Conduct Pancreatic Cancer Clinical Trial in United States
Trial to Also Include Study Sites in Europe and Australia
SILVER SPRING, Md., Oct. 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 its upcoming clinical trial designed to determine whether its pancreatic cancer treatment (Cell-in-a-Box® capsules + low-doses ifosfamide chemotherapy) can satisfy a critical unmet medical need for patients with pancreatic cancer will be conducted in the United States with additional study sites in Europe and Australia.
The decision to conduct the clinical trial in the United States was made because of the need to accelerate the enrollment of patients into the trial and to conduct it in a way that best offers PharmaCyte Biotech the opportunity to get its pancreatic cancer treatment to patients as quickly as possible. If the trial is successful, this could accelerate the review process by drug regulatory authorities for marketing approval of the treatment. In addition, the combination of Abraxane® + gemcitabine is considered to be the “gold standard” for the treatment of patients with advanced pancreatic cancer in the United States, in numerous countries throughout Europe and in Australia. In each of these countries, once patients fail to respond further to the Abraxane® + gemcitabine combination, subsequent therapies are only marginally effective. The goal of PharmaCyte Biotech’s treatment is to fill this void as part of a new “consolidation therapy” for pancreatic cancer patients.
Two of the world’s leading Clinical Research Organizations (CRO), Translational Drug Development (TD2), the premier CRO in the United States specializing in oncology on the forefront of cancer research, and Clinical Network Services (CNS), recently voted Australia’s “best” CRO, will work together conducting the clinical trial. TD2 has assumed the lead role and will be responsible for clinical development plans, program analysis, medical writing, clinical management and database development. TD2 will conduct the clinical trial in the United States. CNS will conduct the clinical trial in Europe and Australia, in alliance with TD2.
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"TD2 has assumed the lead role and will be responsible for clinical development plans, program analysis, medical writing, clinical management and database development. "
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This means we just took our Phase 2b from a 2-3 year trial and made it 1 year...
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This means when we have powerful interim data... Dr. Von Hoff is going to walk it right up to his buddies at the FDA for Pancreatic Cancer and for Pain!!!!
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“We believe that, by conducting our upcoming clinical trial in the United States, Europe and Australia, enrolling patients in the clinical trial will be much faster than previously planned and the overall timeline for the trial will be optimized."
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The decision to conduct the clinical trial in the United States was made because of the need to accelerate the enrollment of patients into the trial and to conduct it in a way that best offers PharmaCyte Biotech the opportunity to get its pancreatic cancer treatment to patients as quickly as possible. If the trial is successful, this could accelerate the review process by drug regulatory authorities for marketing approval of the treatment....
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This means that the man (Dr. Von Hoff) who is responsible for all of the FDA approved Pancreatic Cancer treatments in the last 2 decades is going to be working to get PharmaCyte's Pancreatic Cancer treatment FDA approved....
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Phase 2b Clinical Trial Moved to United States.....
Conducted by TD2 and Dr. Von Hoff!!!!!
This means Dr. Von Hoff will be representing us at the FDA IND meeting....
This means that we're conducting the trial for FDA approval....
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HUGE HUGE NEWS....
PharmaCyte Biotech to Conduct Pancreatic Cancer Clinical Trial in United States
Trial to Also Include Study Sites in Europe and Australia
October 19, 2015 09:48 ET | Source: PharmaCyte Biotech, Inc.
SILVER SPRING, Md., Oct. 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 its upcoming clinical trial designed to determine whether its pancreatic cancer treatment (Cell-in-a-Box® capsules + low-doses ifosfamide chemotherapy) can satisfy a critical unmet medical need for patients with pancreatic cancer will be conducted in the United States with additional study sites in Europe and Australia.
The decision to conduct the clinical trial in the United States was made because of the need to accelerate the enrollment of patients into the trial and to conduct it in a way that best offers PharmaCyte Biotech the opportunity to get its pancreatic cancer treatment to patients as quickly as possible. If the trial is successful, this could accelerate the review process by drug regulatory authorities for marketing approval of the treatment. In addition, the combination of Abraxane® + gemcitabine is considered to be the “gold standard” for the treatment of patients with advanced pancreatic cancer in the United States, in numerous countries throughout Europe and in Australia. In each of these countries, once patients fail to respond further to the Abraxane® + gemcitabine combination, subsequent therapies are only marginally effective. The goal of PharmaCyte Biotech’s treatment is to fill this void as part of a new “consolidation therapy” for pancreatic cancer patients.
Two of the world’s leading Clinical Research Organizations (CRO), Translational Drug Development (TD2), the premier CRO in the United States specializing in oncology on the forefront of cancer research, and Clinical Network Services (CNS), recently voted Australia’s “best” CRO, will work together conducting the clinical trial. TD2 has assumed the lead role and will be responsible for clinical development plans, program analysis, medical writing, clinical management and database development. TD2 will conduct the clinical trial in the United States. CNS will conduct the clinical trial in Europe and Australia, in alliance with TD2.
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We believe that, by conducting our upcoming clinical trial in the United States, Europe and Australia, enrolling patients in the clinical trial will be much faster than previously planned and the overall timeline for the trial will be optimized. We selected TD2 to be the lead CRO because TD2 is setting the standard for new oncology drug approvals in the United States. TD2 is unique in its comprehensive understanding of oncology clinical development. TD2’s world renowned experts in science and medicine have time and again demonstrated their deep commitment to scientific discovery and innovation.”
- See more at: http://globenewswire.com/news-release/2015/10/19/777272/0/en/PharmaCyte-Biotech-to-Conduct-Pancreatic-Cancer-Clinical-Trial-in-United-States.html#sthash.rH8ZFKsz.dpuf
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ALL THE LONGS WERE "smart money" buying pmcb when we realized what this company had...
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PAID ADVERTISING...like on TV...or the Internet...NOT PUMP PR...some people will never get the difference...OR DO THEY?
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THESE ARE SHAREHOLDER UPDATES...AND FOR NEW INVESTORS...not pump PR's as you put it...it baffles me how some people that are posting on penny stocks all the time do not know the difference...OR DO THEY?
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PharmaCyte Biotech CEO in Europe to Secure Orphan Designation With the EMA
SILVER SPRING, Md., Oct. 07, 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, announced today that Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, is currently in Europe ironing out the details that will secure the European Medicines Agency (EMA) Orphan Designation for PharmaCyte Biotech’s pancreatic cancer treatment.
PharmaCyte Biotech’s treatment for advanced pancreatic cancer consists of a unique encapsulation technology known as “Cell-in-a-Box®” in combination with an inactive chemotherapy drug (ifosfamide). The technology encapsulates living cells that have been genetically modified to convert ifosfamide into its active or “cancer-killing” form. The encapsulated cells are first implanted into a patient’s pancreas as close to the tumor as possible. Then ifosfamide is given intravenously as any other chemotherapy agent is, but at one-third the normal dose to eliminate side-effects usually associated with chemotherapy. When the blood carries the ifosfamide to the site of the tumor, activation of the ifosfamide takes place when it comes in contact with the encapsulated live cells - rather than in the liver where it is normally activated.
Waggoner said of his efforts in Europe, “Securing the Orphan Designation in Europe for our pancreatic cancer treatment is vital to our company, as we head into our Phase 2b clinical trial to treat advanced pancreatic cancer. With the Orphan Designation, PharmaCyte Biotech will be provided 10 years of marketing exclusivity throughout Europe for its pancreatic cancer treatment.”
PharmaCyte Biotech will now rely on Clinical Network Services, its Contract Research Organization (CRO) in Australia and Europe, to finalize the documents that will give PharmaCyte Biotech the Orphan Designation with the EMA. Once the European Commission has approved the documents, PharmaCyte Biotech will make an announcement.
- See more at: http://globenewswire.com/news-release/2015/10/07/774237/0/en/PharmaCyte-Biotech-CEO-in-Europe-to-Secure-Orphan-Designation-With-the-EMA.html#sthash.WTObg0Yv.dpuf
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THAT'S OLD NEWS...do you read the the quarterly reports...
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First of all ifosfamide is given intravenously just as it always is except less of it is given...
It enters the body just as it always does and it travels the body as it normally does...
The difference is that instead of being activated in the liver it will encounter cell in a box first and activate there...
There is nothing that will need relabeling there...
The company is not changing the drug, changing its delivery method or mixing it with another drug...
Everything that is done with ifosfamide (minus the dosage - which is a good thing) is the same as it always is...
The only difference is PharmaCyte has basically created an artificial liver at the site of the tumor that will activate it there vs in the liver. No relabeling!
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Becoming so clear how little some know about PMCB...we are not taking a drug to the FDA for approval...Cell in a Box IS A TARGETED DRUG DELIVERY ENCAPSULATION...
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NO... the 185 long investors that you speak of are not going anywhere...and we remember all of the posts here...so this is about to get fun for the longs...
LONGS ARE STAYING STRONG ON PMCB...
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Then let me ask you this...do you really believe PMCB is going to take CiaB to fruition by themselves...point being that it is not what small biotechs do...they do R&D and large bios or big pharma takes it there...small bios that have something big like we do won't have to worry about it...
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When they are getting money to pay for 3 TRIALS...yes it matters to them and us...it means more money for them at a higher price and it means less shares sold for us...
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"When it crosses the $.1838 level the squeeze could be exponential. Get long."
BUYINS.NET
We are initiating coverage on PharmaCyte Biotech (PMCB) as the stock is 10 cents away from crossing above its $.1838 SqueezeTrigger Price. PharmaCyte's technology is called Cell-in-a-Box®. In simplest terms, PharmaCyte Biotech has developed Cell-in-a-Box® as a means of encapsulating and implanting living cells into a patient's body where they can drive a specific therapeutic effect. In the case of PharmaCyte's pancreatic cancer therapy, these encapsulations (about the size of the head of a pin) contain about 10,000 live cells each that produce an enzyme that activates the cancer-fighting drug ifosfamide.
BUYINS.NET
GO LONG NOW...we could gain that in a day or 2 with the right PR...
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Pharmacyte Biotech Puts the Kibosh on Improper Short-Selling (PMCB)
With one simple stroke of the pen, so to speak, Pharmacyte Biotech Inc. (OTCMKTS:PMCB) has quelled a major headwind for its shares.
Not that it was a big problem for Pharmacyte Biotech Inc. (OTCMKTS:PMCB), but to the extent it was a headache, the company has taken steps to abate it. What's that? Pharmacyte Biotech has hired an organization to ensure market makers and brokerage firm are properly reporting - and pricing - trading activity for PMCB, but perhaps more important, the company is ensuring any short-selling of the stock is being handled properly.
Short-selling is the act of selling a stock before one actually owns. The "purchase" comes at the end to close out the trade, hopefully at a lower price. Said another way, rather than the typical "buy low, sell high" strategy, short-sellers aim to "sell high, buy low."
Yes, it's perfectly legal, though the letter of the law isn't always followed perfectly. That can present an impasse to small companies like Pharmacyte Biotech, with small floats and stock prices that can be pushed around for nefarious purposes.
Not that it was happening much (only 119,000 share of PMCB are held as short positions right now versus a float of 620 million shares and average daily volume of 1.68 million), but if it was happening - and it likely is to some extent - the company has basically quelled it by hiring a company called Buyins.Net to monitor this activity to make sure it's happening within regulations. The mere presence of Buyins' eyeballs should shut down the most destructive of the practice for Pharmacyte Biotech.
Buyins.Net will also watch the market makers to ensure they're facilitating trades at the actual market prices, rather than squeeze off a little extra dosh for themselves by offering trades "away" from the actual market prices.
This will likely clean up the bulk of the activity that unfairly works against PMCB shares. Though it won't prevent (nor should it) legal and proper short sales, those aren't the ones to worry about.
For more on Pharmacyte Biotech, visit the company website here.
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PMCB is the best bio I ever bought...everything we bought this bio for is coming to fruition...don't worry about us longs...we got it covered...
bull...
The chart doesn't matter with PMCB by now....and won't matter when we receive IND's and get into human trials...no one here is stopping that from happening...
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PMCB GOING INTO SEVERAL HUMAN CLINICAL TRIALS ...enough said...
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PMCB by years end ...going into several human trials...I DON'T THINK SO...
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ADDING TO PMCB at this point before trials begin...
but thanks for your interest in us longs...
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PMCB BUY NOW...anyone can see they are going into several trials...
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NO THANK YOU...I AM BUYING PMCB...
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Maybe traders should think about buying now on their swing trade...it won't always go their way....
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When PMCB gets into Multiple Trials what will be the response to that...I think some people are running out of negative remarks...or they look just plain silly saying them....
good luck though...I'm looking forward to it...
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PharmaCyte Biotech Discusses Major Milestones Ahead of Phase 2b Clinical Trial in Pancreatic Cancer
PharmaCyte Biotech, Inc.
September 15, 2015 9:30 AM
GlobeNewswire
SILVER SPRING, Md., Sept. 15, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (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 can not believe someone calls this a fluff piece lol....
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I think many people are going to be surprised when PMCB plays out...of course all the longs already know why they bought and are holding this company...but the others...they have a shock coming to them...
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PMCB IS DOING IT RIGHT......
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IND'S HERE WE COME...PMCB IS MOVING IN THE RIGHT DIRECTION......and yes I said IND's...MULTIPLE...
I hope you guys really took in and absorbed what you read yesterday on the PR...it was genius how the PR was constructed like milestones that everyone could check off...
I hope you don't get tied up with the pps not moving and let that overplay what is happening right now....
THIS IS THE BEGINNING of what we have been waiting for and WHY WE ALL BOUGHT this tiny little hidden gem...
I am so excited I want to jump out of my skin...I am not going through what is coming... in the dead zone or thinking about the pps...I AM GOING TO ENJOY EVERY MOMENT THE NEXT FEW MONTHS...you guys do the same
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