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Yes its looking good on PFE Im going to sell my shares tomorrow that I bought at 36.00.It was a struggle but now it has paid. It just wouldnt move in the beginning but on a stock like this I sell into strength. Keeping 2000 shares that Ive had for yrs but selling 5k tomorrow just to lock in the profits for the boat. A trade is just a trade and when you make 10 points on 5000 shares you say thank you. Have a great day
Commenting on PharmaCyte’s upcoming clinical trial, renowned oncologist and clinician Dr. Manuel Hidalgo, who will be the Principal Investigator for the trial, said, “The primary goal of the study is to determine the efficacy of this approach, compared to a standard of care treatment, in controlling LAPC. If this endpoint is met, the technology will be validated as a therapeutic option in patients with LAPC.”
Dr. Hidalgo also knows the significance of shrinking tumors in patients with LAPC and stated, “Patients who undergo a successful operation may be indeed cured of the disease. So, if this strategy is able to increase the number of patients that can undergo surgery to remove their previously inoperable tumors, that could be a very important finding.”
Prof. Walter H. Gunzburg, the co-founder and Chief Technical Officer of Austrianova, said of targeted cellular therapies and specifically Cell-in-a-Box®, which Austrianova helped to develop, “This is the future of medicine, this is the new generation of how we’re going to be able to treat diseases—not only cancer but a whole plethora of other diseases. We’re going to be able to take cells; we’re going to program them to do what we want, and we’re going to put them back into patients’ bodies and they’re going to react to signals in the patient to produce medicines in the right way. So, what PharmaCyte is doing and what we’re doing with PharmaCyte is we’re actually taking the first few bold steps for the new medicines for the next generation.”
Validating the Cell-in-a-Box® technology in an FDA clinical trial will confirm that PharmaCyte has a role in shaping the future of treating diseases using cellular therapies. As monumental as it would be for PharmaCyte to shrink what were once considered inoperable tumors to the point that they are now made operable, validation of the technology is equally as monumental for patients worldwide who suffer from other hard-to-treat diseases and who could now find hope in Cell-in-a-Box® to specifically treat some of those diseases.
For anyone that doesnt think DR. Hidalgo is PMCB's ace in the hole just look at what he has done at the other company he held a stock position in. He is an eye on the latest and greatest things in biotech and PMCB has one of them. He is top in his field and he loves PMCB. Why do you think he designed the PMCB trial ? Why do you think he is the PI of the PMCB trial???? Do you think he believes in PMCB's treatment well just look at his actions not even his words. Oh also look at his ownership in PMCB and his other one that just did a major deal with a company that he sits on the board lol I wont mention the name but its easy to find it. Once the IND gets the thumbs up which we now know what the NEW COVID FDA wants for our trial it will happen 1 step at a time. Above $10.00 I can show this to many hedge funds and they are all looking for the next best way to treat Cancer let alone Pancreatic Cancer.
Manuel Hidalgo, M.D., Ph.D., is currently the Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital. Dr. Hidalgo received his M.D. from the University of Navarra in Pamplona, Spain in 1992, and Ph.D. from University Autonoma of Madrid in 1997. He trained in medicine and medical oncology at Hospital "12 de Octubre" in Madrid and at the University of Texas Health Science Center in San Antonio, Texas. He also completed a fellowship program in anticancer drug development at the Institute of Drug Development in San Antonio. Prior to this position, he served as an Assistant Professor of Medicine at the Division of Hematology and Oncology at the University of Texas Health Science Center in San Antonio. In 2001, Dr. Hidalgo relocated to Johns Hopkins University to serve as Director of the Gastrointestinal Oncology Program at the Kimmel Comprehensive Cancer Center, where he also held the title of Associate Professor of Oncology. Dr. Hidalgo became Director of the Clinical Research Program at the Spanish National Cancer Center in 2009 and Vice Director of Translational Research in 2011. In 2015, he became the Chief of the Division of Hematology and Oncology and Director of the Rosenberg Clinical Cancer Center at the Beth Israel Deaconess Medical Center in Boston. Dr. Hidalgo also served as the Theodore W. and Evelyn G. Berenson Professor of Medicine at Harvard Medical School. His main focus of research has been new drug development in pancreatic cancer. His group popularized the use of Avatar mouse models for cancer research and recently contributed to the development and Federal Drug Administration (FDA) approval of nab-paclitaxel for pancreatic cancer treatment. Dr. Hidalgo’s current research focuses on strategies for personalized medicine and immunotherapy in pancreatic cancer. Dr. Hidalgo also serves on the Board of Directors for Bristol Myers Squibb (BMS).
The FDA's Accelerated Approval Program allows for the approval of an investigational drug or treatment based on a surrogate endpoint (a measurement that can "stand in" for an accepted measurement of disease progression) in early-phase studies if the condition is serious or life-threatening, and Pharmacyte should have an excellent case for just such an approval.
If that were to happen, the company may or may not be required to conduct a Phase 3 trial while its treatment is being used by patients with advanced, inoperable pancreatic cancer. It would, however, undergo a Phase 4 or "confirmatory study" to further evaluate and confirm the efficacy and safety of the treatment, but it would do so with Cell-in-a-Box® combined with ifosfamide on the market.
Well, as Dr. Hidalgo, Principal Investigator of PharmaCyte’s trial, says, “If the results are positive, these results may pave the way for an accelerated approval process through one or more avenues afforded by the FDA.”
This post is fact and should be posted daily here on the PMCB board it should also be sticky on the opening page. Anyone that feels they should post it daily please be my guest . This is a fact and was said by the top Pancreatic Doctor in the world that happens to be the PI of our trial and designed it. Dr. Hildgo of the Weil Cornell belives our treatment could treat all solid tumors.
PharmaCyte’s Clinical Trial in Pancreatic Cancer Serves as Proving Ground for Its One of a Kind Cell Encapsulation Technology. Our partner ( the creator of CELL IN THE BOX Austrianova/SG Austria announced that after extensive due diligence Real Tech Fund (Japan) has invested an undisclosed seven figure amount in Austrianova.Austrianova Secures $100 Million USD Investment Commitment from GEM as Company Seeks to Go Public
PharmaCyte Biotech, Inc. (OTCQB: PMCBD) is closing in on what will be a landmark event in this small company’s history—a clinical trial in the United States under the watchful eye of the most powerful drug regulatory agency in the world, the U.S. Food and Drug Administration (FDA). It would be the company’s first clinical trial ever and could serve as the event that changes the way solid cancerous tumors are treated, while at the same time, proving that PharmaCyte has what is considered the “Holy Grail” for diabetes—an encapsulation technology that can live inside the human body and protect the cells inside from the body’s own immune response.
PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box®, is a one-of-a-kind cell encapsulation technology, and its planned clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC, could very well attract a lot of attention from companies, organizations and investors in both the cancer and diabetes spaces.
What makes this cell encapsulation different than others that have been tried? For the treatment of cancer, PharmaCyte’s Cell-in-a-Box® technology is made up of tiny pinhead-sized porous capsules that contain about 20,000 live cells. Unlike many other encapsulation materials, the Cell-in-a-Box® technology offers the following advantages for developing a therapy that will live inside the human body.
Capsules are made of bio-inert material and are biocompatible
Capsules have been proven to be safe, effective and durable inside the human body
Capsules do not elicit immune responses or damage surrounding tissues
Capsules have pores for nutrient and waste transfer
Pores are too small for immune system cells to enter or encapsulated live cells to leave
Manageable logistics and long shelf life
Other encapsulation materials – such as alginate – are less robust and stable. The others break down in a relatively short period of time in the body, allowing the immune system cells to destroy the cells inside of the capsules
None of the others can effectively freeze live cells to ship them to anywhere in the world and then be thawed with approximately 95% viability of the encapsulated live cells
PharmaCyte’s pancreatic cancer candidate is a “targeted chemotherapy” treatment that has proven itself effective and safe to use in past clinical trials. It’s a therapy that has shown little to no treatment-related side effects, and it could significantly reduce tumor size. Chemotherapy with little to no side effects is unheard of in the cancer arena, and, if PharmaCyte is successful in FDA clinical trials, this treatment could truly change the way that patients with solid tumors are treated well into the future.
When given the go-ahead by the FDA to enter a clinical trial after PharmaCyte submits its Investigational New Drug application (IND), it will be the company’s pancreatic cancer treatment that is under the watchful eye of the FDA, but let’s be honest—it is the company’s live-cell encapsulation technology that is truly on trial in the court of public opinion when it comes to future possibilities for Cell-in-a-Box® and its potential applications for solid cancerous tumors and diabetes.
Why would there be so much interest in a “targeted chemotherapy” treatment with little to no treatment-related side effects or in a live-cell encapsulation technology that can survive inside the human body without being attacked by the body’s own immune system cells? Well, sadly it really is all about money. Undoubtedly a better treatment for patients who suffer from LAPC is long overdue; however, developing treatments for other solid cancerous tumors and diabetes are far more lucrative.
Numbers don’t lie and as of 2016, $827-billion are spent annually in the treatment of diabetes worldwide. This is a staggering number, but it certainly sheds some light on why a treatment for diabetes that doesn’t include monitoring glucose levels, diabetics sticking their fingers many times a day, wearing insulin pumps, etc. is being sought by many companies, organizations and universities.
And this is just diabetes. There are many cancers that a therapy like PharmaCyte’s could potentially be developed for as well, including ovarian, liver, breast, and colon.
In a press release, PharmaCyte’s CEO stated that the possibility exists that if the data produced in a planned clinical trial from PharmaCyte’s therapy are significantly better than the data from the comparator arm(s), this may allow PharmaCyte to apply to the FDA for accelerated approval. It is this data along with the survivability of the capsules and the cells inside the capsules that many will be waiting to see. Accelerated approval could be accomplished if PharmaCyte applies for and receives approval for either the Breakthrough Therapy designation or the Fast Track designation.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply as close as possible to the site of the patient’s tumor.
Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at about one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted, and when the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer.
Meanwhile, PharmaCyte already has a diabetes candidate as well. Its therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body and/or beta islet cells. The encapsulation for this therapy is also done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they function as a “bio-artificial pancreas” for purposes of insulin production. Additionally, PharmaCyte says it plans to explore the encapsulation of beta islet cells as an alternative to using genetically modified human cells.
The path forward is clear, and there really is only one thing left to do. PharmaCyte must get the FDA’s approval to begin a clinical trial for the treatment of LAPC, and then use that trial as an opportunity to prove to its shareholders and to those in both the biotechnology and pharmaceutical sectors that are developing treatments for cancer and diabetes that this one-of-a-kind cell encapsulation technology can dramatically change the way that these two diseases are treated.
This video explains Pharmacyte's clinical trial;
https://pharmacyte.com/live-cell-encapsulation/cancer/
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
Microcap PharmaCyte BioTech uplisting to Nasdaq and launching public offering
Aug. 02, 2021 5:31 PM ETPharmaCyte Biotech, Inc. (PMCB)By: Jonathan M Block, SA News Editor
Microcap PharmaCyte Biotech (OTCQB:PMCB) is uplisting to Nasdaq where it will trade under its current symbol.
The company will also offer common stock and warrants to purchase shares of common stock in an underwritten public offering.
H.C. Wainwright is the sole book-runner.
LAGUNA HILLS, Calif. --(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCBD) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that The Nasdaq Stock Market LLC (Nasdaq) has approved the listing of the Company’s common stock on Nasdaq. The Company’s common stock will be listed on Nasdaq under the symbol “PMCB.” PharmaCyte also announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase shares of common stock in an underwritten public offering.
chemo without side effects
Once the street hears about this deal it will go ballistic
Dr Hidalgo as the PI -All the big Pharma are watching what he is working on and dont leave out BMY which he sits on the board of..
NEW YORK --(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has elected Manuel Hidalgo Medina , M.D., Ph.D., to the Board, effective June 1, 2021 . Dr. Hidalgo will serve as a member of the Science & Technology Committee of the Board of Directors.
Dr. Hidalgo , 53, is currently chief of the division of hematology and medical oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center where he is responsible for leading clinical and translational research in hematology, vascular biology and oncology. Dr. Hidalgo is also the E. Hugh Luckey distinguished professor of medicine and associate director for clinical services at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine.
He brings to the Board more than 20 years of experience in translational and clinical research in anticancer drug development with a particular emphasis in gastrointestinal cancers. He has also led the early clinical development of new anticancer agents for pancreatic cancer among other solid tumor cancers.
PharmaCyte Biotech Announces Uplist to The Nasdaq Capital Market and Launch of Public Offering
50 $ a share
I just feel bad for anyone that bought this back when it hit 3.50. We bought it for the January effect and made a huge profit from under .40 and dumped it when it ran on the pump. Buyers be aware ............. And then they do a placement at 1.45 to really put the screws in the coffin. The stock never saw day light after that .
Huge seller just showed up today on TMDI. I guess if it gets delisted no one wants to be holding shares. I dont blame them. Why hold or buy here because if they get delisted it will be so hard to sell to get out.
last pump PR did more harm than good. All it did was let the discounted share buyers(friends not real buyers) find buyers to sell their sub.02 shares too. I hate when that happens. How many days in a row is BZWR down now after that PUMP
Aeterna Zentaris Receives Nasdaq Notification Regarding Minimum Bid Price Compliance;
July 29 2021 - 08:05AM
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that on July 28, 2021, the Company received notice from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company’s common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the “Rule”).
Funny lmao I guess if one doesnt read the whole filing and leaves out the part of which exchange the shares of PMCB will be registered on then they wouldnt know that KW has started the process for PMCB to be listed on the NASD
"Title of each class
to be registered
Name of each exchange on which
each class is to be registered
Common Stock, $0.0001 par value per share
The Nasdaq Stock Market LLC"
No demand for shares of BZWR now because there are so many shares that want to sell the cheap shares they got. BZWR was under .02 this year and those that got restricted discounted shares can now sell them and lock in their profits before it goes back down to those levels again. Have a great day...
Yes its going to be NASD
Securities to be registered pursuant to Section 12(b) of the Act:
Title of each class
to be registered
Name of each exchange on which
each class is to be registered
Common Stock, $0.0001 par value per share
The Nasdaq Stock Market LLC
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that on July 28, 2021, the Company received notice from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company’s common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the “Rule”).
PharmaCyte’s Clinical Trial in Pancreatic Cancer Serves as Proving Ground for Its One of a Kind Cell Encapsulation Technology. Our partner ( the creator of CELL IN THE BOX Austrianova/SG Austria announced that after extensive due diligence Real Tech Fund (Japan) has invested an undisclosed seven figure amount in Austrianova.
PharmaCyte Biotech, Inc. (OTCQB: PMCBD) is closing in on what will be a landmark event in this small company’s history—a clinical trial in the United States under the watchful eye of the most powerful drug regulatory agency in the world, the U.S. Food and Drug Administration (FDA). It would be the company’s first clinical trial ever and could serve as the event that changes the way solid cancerous tumors are treated, while at the same time, proving that PharmaCyte has what is considered the “Holy Grail” for diabetes—an encapsulation technology that can live inside the human body and protect the cells inside from the body’s own immune response.
PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box®, is a one-of-a-kind cell encapsulation technology, and its planned clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC, could very well attract a lot of attention from companies, organizations and investors in both the cancer and diabetes spaces.
What makes this cell encapsulation different than others that have been tried? For the treatment of cancer, PharmaCyte’s Cell-in-a-Box® technology is made up of tiny pinhead-sized porous capsules that contain about 20,000 live cells. Unlike many other encapsulation materials, the Cell-in-a-Box® technology offers the following advantages for developing a therapy that will live inside the human body.
Capsules are made of bio-inert material and are biocompatible
Capsules have been proven to be safe, effective and durable inside the human body
Capsules do not elicit immune responses or damage surrounding tissues
Capsules have pores for nutrient and waste transfer
Pores are too small for immune system cells to enter or encapsulated live cells to leave
Manageable logistics and long shelf life
Other encapsulation materials – such as alginate – are less robust and stable. The others break down in a relatively short period of time in the body, allowing the immune system cells to destroy the cells inside of the capsules
None of the others can effectively freeze live cells to ship them to anywhere in the world and then be thawed with approximately 95% viability of the encapsulated live cells
PharmaCyte’s pancreatic cancer candidate is a “targeted chemotherapy” treatment that has proven itself effective and safe to use in past clinical trials. It’s a therapy that has shown little to no treatment-related side effects, and it could significantly reduce tumor size. Chemotherapy with little to no side effects is unheard of in the cancer arena, and, if PharmaCyte is successful in FDA clinical trials, this treatment could truly change the way that patients with solid tumors are treated well into the future.
When given the go-ahead by the FDA to enter a clinical trial after PharmaCyte submits its Investigational New Drug application (IND), it will be the company’s pancreatic cancer treatment that is under the watchful eye of the FDA, but let’s be honest—it is the company’s live-cell encapsulation technology that is truly on trial in the court of public opinion when it comes to future possibilities for Cell-in-a-Box® and its potential applications for solid cancerous tumors and diabetes.
Why would there be so much interest in a “targeted chemotherapy” treatment with little to no treatment-related side effects or in a live-cell encapsulation technology that can survive inside the human body without being attacked by the body’s own immune system cells? Well, sadly it really is all about money. Undoubtedly a better treatment for patients who suffer from LAPC is long overdue; however, developing treatments for other solid cancerous tumors and diabetes are far more lucrative.
Numbers don’t lie and as of 2016, $827-billion are spent annually in the treatment of diabetes worldwide. This is a staggering number, but it certainly sheds some light on why a treatment for diabetes that doesn’t include monitoring glucose levels, diabetics sticking their fingers many times a day, wearing insulin pumps, etc. is being sought by many companies, organizations and universities.
And this is just diabetes. There are many cancers that a therapy like PharmaCyte’s could potentially be developed for as well, including ovarian, liver, breast, and colon.
In a press release, PharmaCyte’s CEO stated that the possibility exists that if the data produced in a planned clinical trial from PharmaCyte’s therapy are significantly better than the data from the comparator arm(s), this may allow PharmaCyte to apply to the FDA for accelerated approval. It is this data along with the survivability of the capsules and the cells inside the capsules that many will be waiting to see. Accelerated approval could be accomplished if PharmaCyte applies for and receives approval for either the Breakthrough Therapy designation or the Fast Track designation.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply as close as possible to the site of the patient’s tumor.
Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at about one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted, and when the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer.
Meanwhile, PharmaCyte already has a diabetes candidate as well. Its therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body and/or beta islet cells. The encapsulation for this therapy is also done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they function as a “bio-artificial pancreas” for purposes of insulin production. Additionally, PharmaCyte says it plans to explore the encapsulation of beta islet cells as an alternative to using genetically modified human cells.
The path forward is clear, and there really is only one thing left to do. PharmaCyte must get the FDA’s approval to begin a clinical trial for the treatment of LAPC, and then use that trial as an opportunity to prove to its shareholders and to those in both the biotechnology and pharmaceutical sectors that are developing treatments for cancer and diabetes that this one-of-a-kind cell encapsulation technology can dramatically change the way that these two diseases are treated.
looks like thumbs up for the NASD....NICE
Did AEZS get the notification from the NASD yet? Just count the days. Could they be hiding it ??? That would be so wrong if they were.
I hope this doesnt happen again to AEZS it could happen just count the days-- how many days has it been under $1.00? But thats when I bought this pos last time when it was .30 will it happen again probably Just count the days.
NASDAQ notifications
On January 8, 2020, the Company announced that it had received a notification letter from NASDAQ indicating that, because the closing bid price of the Company’s common stock for 30 consecutive business days was below $1.00 per share, the Company no longer meets the minimum bid price requirement set forth in NASDAQ Listing Rule5550(a)(2). NASDAQ Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
Commenting on PharmaCyte’s upcoming clinical trial, renowned oncologist and clinician Dr. Manuel Hidalgo, who will be the Principal Investigator for the trial, said, “The primary goal of the study is to determine the efficacy of this approach, compared to a standard of care treatment, in controlling LAPC. If this endpoint is met, the technology will be validated as a therapeutic option in patients with LAPC.”
Dr. Hidalgo also knows the significance of shrinking tumors in patients with LAPC and stated, “Patients who undergo a successful operation may be indeed cured of the disease. So, if this strategy is able to increase the number of patients that can undergo surgery to remove their previously inoperable tumors, that could be a very important finding.”
Prof. Walter H. Gunzburg, the co-founder and Chief Technical Officer of Austrianova, said of targeted cellular therapies and specifically Cell-in-a-Box®, which Austrianova helped to develop, “This is the future of medicine, this is the new generation of how we’re going to be able to treat diseases—not only cancer but a whole plethora of other diseases. We’re going to be able to take cells; we’re going to program them to do what we want, and we’re going to put them back into patients’ bodies and they’re going to react to signals in the patient to produce medicines in the right way. So, what PharmaCyte is doing and what we’re doing with PharmaCyte is we’re actually taking the first few bold steps for the new medicines for the next generation.”
Validating the Cell-in-a-Box® technology in an FDA clinical trial will confirm that PharmaCyte has a role in shaping the future of treating diseases using cellular therapies. As monumental as it would be for PharmaCyte to shrink what were once considered inoperable tumors to the point that they are now made operable, validation of the technology is equally as monumental for patients worldwide who suffer from other hard-to-treat diseases and who could now find hope in Cell-in-a-Box® to specifically treat some of those diseases.
Funding and good news for our Partner Austrianova that we own 15% of. The makers and creators of our Cell In The Box. Singapore biotech firm receives seven-figure funding to grow probiotics encapsulation business
https://www.nutraingredients-asia.com/Article/2021/07/27/Against-the-number-game-Singapore-biotech-firm-receives-seven-figure-funding-to-grow-probiotics-encapsulation-business?aca_news_section=Global%20Industry%20News&fbclid=IwAR022XgYtUZYHsW7fQXUc8kFCrip5jCOnzeeoP67SG0uSCQ2N7ms4mqjWVA
Against the number game: Singapore biotech firm receives seven-figure funding to grow probiotics encapsulation business
By Tingmin Koe
27-Jul-2021 - Last updated on 27-Jul-2021 at 03:39 GMT
Singapore-based biotech start-up Austrianova, which developed the patented probiotics encapsulation technology ‘bac-in-a-box’, has received a seven-figure investment from Japanese venture capital firm Real Tech Fund to expand its operations.
‘Bac-in-a-box’ uses a patented cellulose sulphate polymer to encapsulate and grow probiotics in beads the size of a granule. The granules can then be freeze-dried into powder, allowing probiotics to survive at room temperature.
A study published last year? also showed that the technology could protect probiotics against gastric acid and reach the lower intestines alive.
Austrianova announced this month that Japanese firm Real Tech Fund has invested a seven-figure amount.
Real Tech Fund specifically invests in innovative start-ups from Japan and South East Asia. It is managed by Real Tech Holdings, a joint venture between biotech firm euglena Co. and Leave a Nest Co.
Speaking to NutraIngredients-Asia, ?Brian Salmons, CEO of Austrianova, said ‘bac-in-a-box’ had attracted interest from a Europe-headquartered MNC and an Australian company, and both have adopted the technology in their upcoming probiotics products.
“Usually, the company would recognise that they want to make a [probiotic] product, but they might have realised that there are issues around shelf storage, or with delivery, or the ability to protect against stomach acid,”? he said.
From his observations, while most probiotics manufacturers are aware of how temperature and pH changes could affect the effectiveness of probiotics, he said that it was usually the new companies which were more receptive of using probiotics encapsulation technology.
“Today, it’s been mainly the start-up companies or established companies that want to do something new and are looking at using cutting edge technologies. ?
“Most of our partners are new companies looking to use cutting edge technologies, and because they are starting from scratch, I guess they have the bandwidth to be able to incorporate a new encapsulation technology.”?
Bac in a Box
A prototype using Bac-in-a-Box technology
Across Asia-Pacific, he pointed out that Japan and South Korea were markets which have a better understanding of probiotics encapsulation technologies.
With the new funding, the company hopes to connect with companies making probiotics and introduce the 'bac-in-a-box' technology to them.
The funding will also be used to ramp up feasibility studies, building prototypes, moving into lab scale production, and pilot production for its customers.
“[However], when their sales took off, we wouldn't be the ones doing the final market production. They would either licence the bac-in-a-box technology to manufacture the products themselves or we will approach a third-party manufacturer together.”?
The more the better? ?
Salmons claimed that a common practice in ensuring probiotics viability is by adding huge number of probiotics so that some could survive till the end of the product shelf life.
“I think sometimes there is a reticence from some of the more established companies to address those issues [of protecting probiotics viability] though. Because the way that they are approaching it at the moment, is that they are putting huge number of live bacteria in their products.?
“And then the customer will compare and think that the more [bacteria] the better and they [the probiotics companies] play on that and that is a selling point.?
“They want to compete on this basis, but I think they are also aware internally that this is not a very good scientific argument,” ?he said. ?
He acknowledged that companies tend to associate new technologies with high cost and this was a major roadblock to overcome.
In response, he pointed out that ‘bac-in-a-box’ uses inexpensive natural polymer as a starting material and is able to grow live probiotics within a tiny bead without the need for a big facility.
“If you are adding for example, 80 billion of bacteria, you will need a huge facility to make those numbers of bacteria, but for us, we grow the bacteria within our beads and need smaller amounts, and that offsets the cost of using the technology.?
“I think, once they see a product out there, where the cost is lower and doesn't use huge numbers of bacteria, then they will be convinced of the benefits of probiotics encapsulation.”
Anyone that doesnt feel Dr Hidalgo believes that PMCB will do well then why would he be a owner of shares in PMCB?
" Dr. Hidalgo also has stock in Agenus and PharmaCyte Biotech Inc., as well as Champions Oncology Inc., a company that supports oncology drug development. Additionally, he has received travel reimbursement from PanCan, Takeda, AACR, Agenus and BioLineRx.
This video explains Pharmacyte's clinical trial;
https://pharmacyte.com/live-cell-encapsulation/cancer/
For anyone that doesnt think DR. Hidalgo is PMCB's ace in the hole just look at what he has done at the other company he held a stock position in. He is an eye on the latest and greatest things in biotech and PMCB has one of them. He is top in his field and he loves PMCB. Why do you think he designed the PMCB trial ? Why do you think he is the PI of the PMCB trial???? Do you think he believes in PMCB's treatment well just look at his actions not even his words. Oh also look at his ownership in PMCB and his other one that just did a major deal with a company that he sits on the board lol I wont mention the name but its easy to find it. Once the IND gets the thumbs up which we now know what the NEW COVID FDA wants for our trial it will happen 1 step at a time. Above $10.00 I can show this to many hedge funds and they are all looking for the next best way to treat Cancer let alone Pancreatic Cancer.
Manuel Hidalgo, M.D., Ph.D., is currently the Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital. Dr. Hidalgo received his M.D. from the University of Navarra in Pamplona, Spain in 1992, and Ph.D. from University Autonoma of Madrid in 1997. He trained in medicine and medical oncology at Hospital "12 de Octubre" in Madrid and at the University of Texas Health Science Center in San Antonio, Texas. He also completed a fellowship program in anticancer drug development at the Institute of Drug Development in San Antonio. Prior to this position, he served as an Assistant Professor of Medicine at the Division of Hematology and Oncology at the University of Texas Health Science Center in San Antonio. In 2001, Dr. Hidalgo relocated to Johns Hopkins University to serve as Director of the Gastrointestinal Oncology Program at the Kimmel Comprehensive Cancer Center, where he also held the title of Associate Professor of Oncology. Dr. Hidalgo became Director of the Clinical Research Program at the Spanish National Cancer Center in 2009 and Vice Director of Translational Research in 2011. In 2015, he became the Chief of the Division of Hematology and Oncology and Director of the Rosenberg Clinical Cancer Center at the Beth Israel Deaconess Medical Center in Boston. Dr. Hidalgo also served as the Theodore W. and Evelyn G. Berenson Professor of Medicine at Harvard Medical School. His main focus of research has been new drug development in pancreatic cancer. His group popularized the use of Avatar mouse models for cancer research and recently contributed to the development and Federal Drug Administration (FDA) approval of nab-paclitaxel for pancreatic cancer treatment. Dr. Hidalgo’s current research focuses on strategies for personalized medicine and immunotherapy in pancreatic cancer. Dr. Hidalgo also serves on the Board of Directors for Bristol Myers Squibb (BMS).
Covered my short on that last new low break if it rallies I will put on a another short.
Dont be surprised if PMCB and Viacyte do a joint venture to treat/cure Diabetes. It would be a perfect fit to get closer to the CURE for diabetes. A merger of the 2 companies would be a blockbuster for Viacyte to go public and be listed on the NASD as one company. A cure for diabetes with the 2 companies working together could happen sooner than anyone would think. What would that be worth in dollars BILLIONS $$$$$$$
ViaCyte developing stem cell-derived islet replacement for diabetes
Leonard Zehr April 20, 2021
Michael Yang, President and CEO
Closely-held ViaCyte, a company with two decades of experience, is utilizing embryonic stem cell technology and novel delivery approaches to address multiple disease areas, with an initial focus and lead products designed to develop a functional cure for Type 1 diabetes.
“As a leading regenerative medicine company, we are developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation,” Michael Yang, president and CEO, says in an interview with BioTuesdays.
“ViaCyte was the first company to apply islet cell replacement therapies derived from pluripotent stem cells in clinical trials for the treatment of diabetes,” he contends.
The company’s two clinical-stage product candidates – PEC-Encap and PEC-Direct – are actively recruiting Type 1 diabetes patients for two, Phase 2 clinical trials. Data are expected in the second half of 2021 for PEC-Encap and first half of 2022 for PEC-Direct, with hopes to file biologics license applications in 2024 and 2025, respectively.
In addition, ViaCyte is expanding cell manufacturing capacity and capabilities to advance PEC-Direct, PEC-Encap, and its immune-evasive cell program for diabetes, PEC-QT, which is partnered with CRISPR Therapeutics, a leading gene-editing company, while also exploring research into new disease areas that may benefit from cell-based therapies, Mr. Yang contends.
“We have six years of experience manufacturing cGMP cells, devices and combination products,” he adds.
Mr. Yang, who moved into the executive suite in January 2021, says he was attracted to ViaCyte after examining its science, management team, manufacturing capabilities, IP position, partnerships and clinical breakthroughs to achieve the first islet cell replacement therapy for Type 1 diabetes.
“When I looked at the landscape, I was convinced we are at the leading edge of using cell therapy and regenerative medicine to address this important disease area.”
Mr. Yang has more than 20 years of senior industry experience, joining ViaCyte from Acadia Pharmaceuticals, where he was EVP and chief commercial officer. He also served as president of Johnson & Johnson’s Janssen Biotech unit, where he was responsible for building Janssen’s U.S. immunology business, generating more than $8-billion in annual revenue.
Some 1.3 million people in the U.S. have Type 1 diabetes, with 40,000 people diagnosed annually. In addition, 8.4% of people with the disease die each year as a result of hypoglycemia, where blood glucose levels drop dramatically below normal. Type 1 and Type 2 diabetes are expensive chronic conditions, resulting in billions of dollars in healthcare costs a year.
Mr. Yang explains that ViaCyte is focused on pluripotent stem cells because of their exceptional capacity to expand to large numbers and the company’s ability to direct their differentiation into various potentially therapeutic, specialized cell types, including pancreatic progenitor and beta cells for Type 1 diabetes.
The pancreatic progenitor cells are then contained in an encapsulation system, which is implanted subcutaneously. Mr. Yang says ViaCyte has shown that once implanted and successfully engrafted, the cells mature into beta cells that secrete insulin, alpha cells that release glucagon, and other cells of the human pancreas that naturally control blood glucose levels.
The company also has developed two device delivery platforms: open and closed, which contain the cell therapy while enabling oxygen and nutrients to flow into the device and insulin, glucagon, and other hormones to flow out. “There is no insulin pump today that produces glucagon, which helps raise blood glucose,” he adds.
The open device platform, which promotes direct vascularization of PEC-Direct but needs immune suppression drugs, is about three-quarters of the size of a bandage and is subcutaneous.
The closed encapsulation system uses a proprietary membrane jointly developed by ViaCyte and W.L Gore & Associates, a global materials science company, to improve engraftment, survival, and overall function of the implanted cells by mitigating the foreign body host response and providing protection from immune rejection, Mr. Yang says.
The closed encapsulation system also is designed to eliminate the need for immune suppression drugs commonly used with other transplants. The combined effort is being applied to the PEC-Encap product candidate.
“ViaCyte has demonstrated that when the cells successfully engraft, they produce both insulin and glucagon in Type 1 diabetes, a first in the field of cell therapy for diabetes,” Mr. Yang contends.
Mr. Yang points out that ViaCyte also is developing an immune-evasive cell line, PEC-QT, with CRISPR Therapeutics that is earmarked for the open device to avoid destruction by the patient’s immune system, potentially eliminating the need for immunosuppressants. The program currently is in preclinical testing, with plans to file a clinical trial application in the fourth quarter of 2021.
ViaCyte and CRISPR Therapeutics formed a partnership in 2018 to discover, develop, and commercialize gene-edited allogeneic stem cell-derived therapies, which could be a next-generation functional cure for all insulin-requiring Type 1 and Type 2 diabetes patients, he adds.
Mr. Yang said ViaCyte’s clinical program has shown human proof of concept. Nine of 33 patients with therapeutic device implants using the open device platform have shown improved time-in-range for normal blood glucose levels, histologic evidence of insulin and glucagon-secreting cells, and higher levels of C-peptide in the body, which provides evidence of graft-derived insulin production. All nine patients were C-peptide negative at enrollment, he adds.
With Type 1 diabetes, the pancreas makes little to no insulin, and little or no C-peptide, a biomarker used to help tell the difference between Type 1 and Type 2 diabetes.
Mr. Yang points out that a 22% increase in time-in-range equates to about 5.3 hours a day or 80 more days a year in euglycemic range.
In the closed device platform using PEC-Encap, 17 clinical subjects implanted with the Gore membrane device demonstrated that the encapsulation system reduced the foreign body response and improved engraftment, cell survival, and function. This program began a Phase 2 clinical trial in January with data expected in Q4 2021.
ViaCyte has more than 780 issued patents worldwide, of which more than 125 are in the U.S., with critical patents running until 2037. The company has some 250 patent applications pending worldwide.
Mr. Yang points out that ViaCyte’s patents cover all seven stages of cell differentiation, cell and combination product manufacturing, device and membrane designs, and potential for multiple other therapeutic areas where “our technology can make a difference for patients.”
Some areas for prioritization include chronic liver failure, hypoparathyroidism and hypothyroidism, and Type 2 diabetes, he suggests.
“Our foundation is built on deep expertise in translating science, manufacturing and device delivery into innovative solutions for patients,” Mr. Yang says. “We continue to be leaders in the field with our world class partnerships with CRISPR Therapeutics for development of a first-in-class immune evasive cell line and W. L. Gore for novel device and membrane technologies.”
just like I said yesterday about NIO decent support at 31.00$. I did cover half my short position this morning lets see how this trades for the rest of the week. Have a great day
"55.00 to 41.00 the only ones that are happy are the ones that shorted NIO above 53.00. If it takes out the double low around 40.50 the next level of support will be 31.00. I see it going lower because of the regulations introduced by the Chinese government regarding for-profit education companies, which investors fear may have implications for other industries. Good luck"
For anyone that doesnt think DR. Hidalgo is PMCB's ace in the hole just look at what he has done at the other company he held a stock position in. He is an eye on the latest and greatest things in biotech and PMCB has one of them. He is top in his field and he loves PMCB. Why do you think he designed the PMCB trial ? Why do you think he is the PI of the PMCB trial???? Do you think he believes in PMCB's treatment well just look at his actions not even his words. Oh also look at his ownership in PMCB and his other one that just did a major deal with a company that he sits on the board lol I wont mention the name but its easy to find it. Once the IND gets the thumbs up which we now know what the NEW COVID FDA wants for our trial it will happen 1 step at a time. Above $10.00 I can show this to many hedge funds and they are all looking for the next best way to treat Cancer let alone Pancreatic Cancer. Have a great day....
55.00 to 41.00 the only ones that are happy are the ones that shorted NIO above 53.00. If it takes out the double low around 40.50 the next level of support will be 31.00. I see it going lower because of the regulations introduced by the Chinese government regarding for-profit education companies, which investors fear may have implications for other industries. Good luck
Austrianova Secures $100 Million USD Investment Commitment from GEM Global Yield LLC
This will be a good thing for PMCBD because we own 15% of AN. Eyes will soon turn to PMCB for purchase. Once the IND is opened from the FDA buyers will be jumping on PMCB and there wont be many shares for sale at this low price. There are only approximately 1.6 million shares outstanding common shares now and if a buyer wants to get in they are going to have to pay up. If a big Pharma wants in they will just buy the whole company in one shot. What could the price be once the IND is approved???? $100 a share $200 a share time will tell. Lets see what Dr Hidalgo tells BMY he is on their Board and he is Our PI and designer of our trial and has big beliefs in our treatment.
"Commenting on PharmaCyte’s upcoming clinical trial, renowned oncologist and clinician Dr. Manuel Hidalgo, who will be the Principal Investigator for the trial, said, “The primary goal of the study is to determine the efficacy of this approach, compared to a standard of care treatment, in controlling LAPC. If this endpoint is met, the technology will be validated as a therapeutic option in patients with LAPC.”
Dr. Hidalgo also knows the significance of shrinking tumors in patients with LAPC and stated, “Patients who undergo a successful operation may be indeed cured of the disease. So, if this strategy is able to increase the number of patients that can undergo surgery to remove their previously inoperable tumors, that could be a very important finding.”
Not many shares for sale anyone that wants to buy size will have to pay up in price and thats a very good thing for those that are long PMCBD
Early January it was under .35 We bought it back then for the January effect. We do it every yr and it is very profitable for us over the yrs. We have our people search for stocks that fit the bill and AEZS was a candidate and we bought a good amount. We never thought AEZS would be pumped up to 3.50 but we sold it all the way up most shares were sold cheaper but a gift is a gift lol. We are waiting for another gift from AEZS and I think its coming very soon. I wouldnt mind buying 250k shares under .40 get ready the days are being counted for the delisting notice. Good luck to all and may your profits be big..............
Will the new surge in cases of Covid put TAWNF into bankruptcy ??? Im so glad I dumped my shares at .25 on bs run up
"Air travel in Asia may take three years to recover from COVID-19 impact
The fast-spreading Delta variant, compounded by low rates of vaccinations, and localised lockdowns have slowed down the recovery in the continent.
Fewer flights have also impacted the demand for jet fuel. Asia’s jet fuel usage accounted for a third of the global consumption in 2019. “We currently expect Asian jet demand will not reach pre-pandemic levels until 2023-2024, although domestic travel will have largely recovered by the end of 2022,” said analyst George Dix to the news site."
Bring it down to .30 -.40 on the delisting notice and Id buy AEZS for a trade again. It could happen this week if you count the days. Will they try to hide the notice that would be very scammy I hope not. Rules are rules and if they break them there is a punishment for sure.
Here are the facts :notification letter from NASDAQ comes indicating that, because the closing bid price of the Company’s common stock for 30 consecutive business days was below $1.00 per share, the Company no longer meets the minimum bid price requirement set forth in NASDAQ Listing Rule5550(a)(2). NASDAQ Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
I hope this doesnt happen again to AEZS it could happen just count the days-- how many days has it been under $1.00? But thats when I bought this pos last time when it was .30 will it happen again probably Just count the days.
NASDAQ notifications
On January 8, 2020, the Company announced that it had received a notification letter from NASDAQ indicating that, because the closing bid price of the Company’s common stock for 30 consecutive business days was below $1.00 per share, the Company no longer meets the minimum bid price requirement set forth in NASDAQ Listing Rule5550(a)(2). NASDAQ Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
Commenting on PharmaCyte’s upcoming clinical trial, renowned oncologist and clinician Dr. Manuel Hidalgo, who will be the Principal Investigator for the trial, said, “The primary goal of the study is to determine the efficacy of this approach, compared to a standard of care treatment, in controlling LAPC. If this endpoint is met, the technology will be validated as a therapeutic option in patients with LAPC.”
Dr. Hidalgo also knows the significance of shrinking tumors in patients with LAPC and stated, “Patients who undergo a successful operation may be indeed cured of the disease. So, if this strategy is able to increase the number of patients that can undergo surgery to remove their previously inoperable tumors, that could be a very important finding.”
Prof. Walter H. Gunzburg, the co-founder and Chief Technical Officer of Austrianova, said of targeted cellular therapies and specifically Cell-in-a-Box®, which Austrianova helped to develop, “This is the future of medicine, this is the new generation of how we’re going to be able to treat diseases—not only cancer but a whole plethora of other diseases. We’re going to be able to take cells; we’re going to program them to do what we want, and we’re going to put them back into patients’ bodies and they’re going to react to signals in the patient to produce medicines in the right way. So, what PharmaCyte is doing and what we’re doing with PharmaCyte is we’re actually taking the first few bold steps for the new medicines for the next generation.”
Validating the Cell-in-a-Box® technology in an FDA clinical trial will confirm that PharmaCyte has a role in shaping the future of treating diseases using cellular therapies. As monumental as it would be for PharmaCyte to shrink what were once considered inoperable tumors to the point that they are now made operable, validation of the technology is equally as monumental for patients worldwide who suffer from other hard-to-treat diseases and who could now find hope in Cell-in-a-Box® to specifically treat some of those diseases.
PharmaCyte’s Clinical Trial in Pancreatic Cancer Serves as Proving Ground for Its One of a Kind Cell Encapsulation Technology
PharmaCyte Biotech, Inc. (OTCQB: PMCBD) is closing in on what will be a landmark event in this small company’s history—a clinical trial in the United States under the watchful eye of the most powerful drug regulatory agency in the world, the U.S. Food and Drug Administration (FDA). It would be the company’s first clinical trial ever and could serve as the event that changes the way solid cancerous tumors are treated, while at the same time, proving that PharmaCyte has what is considered the “Holy Grail” for diabetes—an encapsulation technology that can live inside the human body and protect the cells inside from the body’s own immune response.
PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box®, is a one-of-a-kind cell encapsulation technology, and its planned clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC, could very well attract a lot of attention from companies, organizations and investors in both the cancer and diabetes spaces.
What makes this cell encapsulation different than others that have been tried? For the treatment of cancer, PharmaCyte’s Cell-in-a-Box® technology is made up of tiny pinhead-sized porous capsules that contain about 20,000 live cells. Unlike many other encapsulation materials, the Cell-in-a-Box® technology offers the following advantages for developing a therapy that will live inside the human body.
Capsules are made of bio-inert material and are biocompatible
Capsules have been proven to be safe, effective and durable inside the human body
Capsules do not elicit immune responses or damage surrounding tissues
Capsules have pores for nutrient and waste transfer
Pores are too small for immune system cells to enter or encapsulated live cells to leave
Manageable logistics and long shelf life
Other encapsulation materials – such as alginate – are less robust and stable. The others break down in a relatively short period of time in the body, allowing the immune system cells to destroy the cells inside of the capsules
None of the others can effectively freeze live cells to ship them to anywhere in the world and then be thawed with approximately 95% viability of the encapsulated live cells
PharmaCyte’s pancreatic cancer candidate is a “targeted chemotherapy” treatment that has proven itself effective and safe to use in past clinical trials. It’s a therapy that has shown little to no treatment-related side effects, and it could significantly reduce tumor size. Chemotherapy with little to no side effects is unheard of in the cancer arena, and, if PharmaCyte is successful in FDA clinical trials, this treatment could truly change the way that patients with solid tumors are treated well into the future.
When given the go-ahead by the FDA to enter a clinical trial after PharmaCyte submits its Investigational New Drug application (IND), it will be the company’s pancreatic cancer treatment that is under the watchful eye of the FDA, but let’s be honest—it is the company’s live-cell encapsulation technology that is truly on trial in the court of public opinion when it comes to future possibilities for Cell-in-a-Box® and its potential applications for solid cancerous tumors and diabetes.
Why would there be so much interest in a “targeted chemotherapy” treatment with little to no treatment-related side effects or in a live-cell encapsulation technology that can survive inside the human body without being attacked by the body’s own immune system cells? Well, sadly it really is all about money. Undoubtedly a better treatment for patients who suffer from LAPC is long overdue; however, developing treatments for other solid cancerous tumors and diabetes are far more lucrative.
Numbers don’t lie and as of 2016, $827-billion are spent annually in the treatment of diabetes worldwide. This is a staggering number, but it certainly sheds some light on why a treatment for diabetes that doesn’t include monitoring glucose levels, diabetics sticking their fingers many times a day, wearing insulin pumps, etc. is being sought by many companies, organizations and universities.
And this is just diabetes. There are many cancers that a therapy like PharmaCyte’s could potentially be developed for as well, including ovarian, liver, breast, and colon.
In a press release, PharmaCyte’s CEO stated that the possibility exists that if the data produced in a planned clinical trial from PharmaCyte’s therapy are significantly better than the data from the comparator arm(s), this may allow PharmaCyte to apply to the FDA for accelerated approval. It is this data along with the survivability of the capsules and the cells inside the capsules that many will be waiting to see. Accelerated approval could be accomplished if PharmaCyte applies for and receives approval for either the Breakthrough Therapy designation or the Fast Track designation.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply as close as possible to the site of the patient’s tumor.
Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at about one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted, and when the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer.
Meanwhile, PharmaCyte already has a diabetes candidate as well. Its therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body and/or beta islet cells. The encapsulation for this therapy is also done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they function as a “bio-artificial pancreas” for purposes of insulin production. Additionally, PharmaCyte says it plans to explore the encapsulation of beta islet cells as an alternative to using genetically modified human cells.
The path forward is clear, and there really is only one thing left to do. PharmaCyte must get the FDA’s approval to begin a clinical trial for the treatment of LAPC, and then use that trial as an opportunity to prove to its shareholders and to those in both the biotechnology and pharmaceutical sectors that are developing treatments for cancer and diabetes that this one-of-a-kind cell encapsulation technology can dramatically change the way that these two diseases are treated.
The FDA's Accelerated Approval Program allows for the approval of an investigational drug or treatment based on a surrogate endpoint (a measurement that can "stand in" for an accepted measurement of disease progression) in early-phase studies if the condition is serious or life-threatening, and Pharmacyte should have an excellent case for just such an approval.
If that were to happen, the company may or may not be required to conduct a Phase 3 trial while its treatment is being used by patients with advanced, inoperable pancreatic cancer. It would, however, undergo a Phase 4 or "confirmatory study" to further evaluate and confirm the efficacy and safety of the treatment, but it would do so with Cell-in-a-Box® combined with ifosfamide on the market.
Well, as Dr. Hidalgo, Principal Investigator of PharmaCyte’s trial, says, “If the results are positive, these results may pave the way for an accelerated approval process through one or more avenues afforded by the FDA.”
This post is fact and should be posted daily here on the PMCB board it should also be sticky on the opening page. Anyone that feels they should post it daily please be my guest . This is a fact and was said by the top Pancreatic Doctor in the world that happens to be the PI of our trial and designed it. Dr. Hildgo of the Weil Cornell belives our treatment could treat all solid tumors.
Does anyone know what this law suit was about they had to pay former officers.
Aeterna Zentaris Settles Dispute with David Dodd and Philip Theodore
-- Aeterna Zentaris Inc., (NASDAQ:AEZS) (TSX: AEZS) has settled its previously disclosed litigation in South Carolina and Canada with former officers of the Company, David Dodd and Philip Theodore. As part of that settlement, the Company has agreed to make a settlement payment to Mr. Dodd in the amount of $775,000.