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"For a myriad of reasons, this is unquestionably good news for the Company, our shareholders and the patients we hope to treat. Most importantly, we now have the capital to complete the work necessary to satisfy the FDA's requests to lift the clinical hold and receive an open Investigational New Drug application (IND) for our treatment in locally advanced, inoperable pancreatic cancer (LAPC). In addition, PharmaCyte is positioned to immediately move into a fully funded clinical trial in LAPC should the FDA lift the clinical hold. Also, because the Company is now well-capitalized, we can broaden our entire development pipeline, including our diabetes and malignant ascites programs.
"We were able to attract institutional investors to accomplish this substantial raise while maintaining our low-float, and we have no plans to raise additional capital any time soon."
To learn what PMCB will be doing in their up coming trial just watch the video..
Dr.Manuel Hidalgo on PMCB
Professor of Medicine. Chief of Hem/Onc at Weill Cornell Medicine/New York Presbyterian Hospital. Pancreatic cancer researcher.
Dr. Hidalgo expanded the list of possibilities saying, “As this technology is extremely versatile in the sense that different cell types with different genetic manipulations can be used, the range of cancer types that can be treated is vast. It is envisioned that this clinical trial will open the opportunity to explore the same technology in other hard-to-treat cancers like liver, cholangiocarcinoma, head and neck cancer, brain tumors and others. Furthermore, the range of cells that can be encapsulated in Cell-in-a-Box® as well as the genetic modifications that can be made to these cells is just huge.”And the list doesn’t stop there. In addition to potential treatments for a number of cancers and for diabetes using different types of cells, the list of treatments grows exponentially when we discuss stem cells. In addition to encapsulating stem cells to treat diabetes, the encapsulation of stem cells can also be used to regenerate and repair diseased or damaged tissues in patients. These stem cell therapies are available for people with spinal cord injuries, Parkinson’s disease, Alzheimer’s disease, heart disease, strokes, burns and even cancer.Researchers continue to develop new ways in which stem cells can be conducive to better regenerative medicine approaches, to be eventually applied in transplants. Again, protecting stem cells using PharmaCyte’s technology would solve the long-standing concern over safety and efficacy of stem cell therapy to treat diseases and conditions of organs and tissues in patients.Today’s healthcare market offers few effective ways to treat the root causes of many diseases or conditions. In many cases, typical treatments can only manage a patients’ symptoms with medications or devices, providing only temporary symptomatic relief.PharmaCyte’s CEO believes that validating Cell-in-a-Box® will open many doors to the future of cellular therapies for his company. “What PharmaCyte is involved with can lead to a game-changing approach to treating numerous degenerative diseases. By encapsulating certain types of stem cells and protecting them, the body is given a chance to heal itself. This type of therapy is the future of medicine—medicine that offers the realistic promise of repairing damaged tissue and reversing the effects of many degenerative conditions, offering solutions for people with diseases that today are beyond repair.”
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: PMCB) 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.
A positive write up on PMCB from seeking alpha that is very different than the past writes up
https://seekingalpha.com/article/4451013-pharmacyte-biotech-buy-the-dump?mail_subject=pmcb-pharmacyte-biotech-buy-the-dump&utm_campaign=rta-stock-article&utm_content=link-2&utm_medium=email&utm_source=seeking_alpha
Anthony Cataldo
6.64K Followers
PharmaCyte Biotech: Buy The 'Dump'
"I recommend that you nibble a few shares of PharmaCyte Biotech if interested in a “trade” or a very high-risk long-term buy-and-hold."
"If the investment community can be convinced that the PharmaCyte drug pipeline shows promise, it is not inconceivable that a large pharmaceutical may exhibit some interest - preferably financial interest or partnering interest. This could be very rewarding to shareholders choosing to enter at current PPS levels. I am willing to accept the risk/reward, at least for a few quarters and until I can re-evaluate the firm's cash burn and fundamentals."
Thank you Dr. Hidalgo for all that you have done here with AGEN in just a few months we went from 2.50 to almost 6.50 and will be helping save lives. I hope your work will do the same for my other company that you are on the board of and the PI of their trial. AGEN is looking great with the BMY investment... mmmm
Agenus to receive a $200 million upfront payment and up to $1.36 billion in milestone payments
Bristol-Myers Squibb Company (NYSE:BMY) and Agenus Inc. (NASDAQ:AGEN) today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted a global exclusive license to Agenus' proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target. AGEN1777 is an Fc-enhanced antibody in late preclinical development designed to target major inhibitory receptors expressed on T and NK cells to improve anti-tumor activity. In preclinical studies this approach has shown significant potential in tumor models where anti-PD-1 or anti-TIGIT monospecific antibodies alone are ineffective.
Looking to buy a chunk of shares today come on push it down a lil bit lower and fill my 50k. light volume selloffs are the best when you want to add more shares only 3 more trading days left in the month
NIO has been a great short for us. We covered the other day and are looking to put new shorts out again. Ca CHING ring the cash register again
Be careful a paid promotion has started here. I got an email this morning on CTXR
PMCB got a nice mention in this publication today
https://www.scienceboard.net/index.aspx?sec=ser&sub=def&pag=dis&ItemID=3183&fbclid=IwAR0hUqBYJ99hAncMvxNJsi8tf2Ud8jMd8qAel7JEAX_ZSR0KCalyCAVp_70
Laguna Hills-based PharmaCyte Biotech, a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, announced that it had entered into agreements with institutional investors for the purchase and sale of 14 million shares of the company's common stock for gross proceeds of $70 million. PharmaCyte's product candidate for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body.
So did our partner that we own 20% of: Austrianova secured an undisclosed amount of financing from Real Tech. The funding will support the company's next stage of growth in production capacity for its protective cell encapsulation technology. It also enhances and facilitates Austrianova's entry into the Japanese market with its cell-in-a-box and bac-in-a-box technologies.
The gap was just filled and any true trader/ investor really hates to see gaps on a chart. I just added more shares and will watch this move higher from here. All that buy down here have bought cheaper than the placement at 5.00 so its a no brainer for me to say BUY BUY BUY here. Ive seen this perfect action pay me many times in the past. Lets fight Pancreatic cancer and Diabetes will make shareholders RICH if they play their cards right. Have a great day see you at much higher prices ........................
Now is the perfect time to BUY PMCB. Good news will start to flow as it has started today there is more to come. There will be no reason to raise any additional funds for the future .We have 90 MILLION in the bank. Does anyone know what PMCB will be worth if we can cure Diabetes??? Do the DD and one will see how many of billions of dollars are spent on Diabetes medication alone. We already have large institution funds and investors buying just wait till we get the IND to move forward. BOOM TO THE MOON$$$$$
I am so glad I bought all those cheap shares the other day $$$ they are keepers for sure
$90 million in cash in its bank account. strong strong strong
AGUNA HILLS, Calif. --(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (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 the closing of its previously announced registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company’s common stock (or pre-funded warrants to purchase common stock in lieu of common stock) at an effective purchase price of $5.00 per share for gross proceeds of approximately $70 million , before deducting the placement agent’s fees and other offering expenses payable by the Company. In a concurrent private placement, PharmaCyte also issued to the investors in the offering unregistered warrants to purchase up to an aggregate 7,000,000 shares of common stock.
Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock of the Company will be 18,979,465 and the Company will have approximately $90 million in cash in its bank account.
Got back into CELH back in May around 45.00$ did it with options and so happy to be holding these shares. John you have stepped up and ten times more than anyone thought .Thank you again and as you know I use the products everyday me and Flo................
Wow KW the CEO got us ODD could he get us Breakthrough Therapy https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy with 80 mil in the bank he can do it all lol
Nice day for PMCB lmao
85 million in the Bank to go forward and more buyers at 5.00
Pharmacyte owns 15% of this company AUSTRIANOVA. We are partners on "Cell In the Box" with them and all Cancer therapys and
Diabetes which could be life changing for many people and make PMCB BILLIONS with a cure
https://www.globalbankingandfinance.com/cancer-gene-therapy-market-set-to-surge-significantly-during-2020-2028-key-players-american-gene-technologies-arcellx/?fbclid=IwAR204oq2QxDaPx69z6GTIi-GKLH6zVrhZkp2qXfdjLxwKquUuwdhxgDvOVI
Wow insiders are buyers I love it. Funny thing I get a call from My Father today and he asked me why I bought him 20000 shares of PMCB about a week ago around $2.80 and sold it so fast. He said he liked the Company and what they are trying to do with Pancreatic cancer. He asked me why I would sell it so fast. He didnt look at the price that I sold them at and when I told him what the sale price was he said Son you have always done the right thing but he said buy him shares back as soon as possible lol also he thanked me and said he owes me a dinner lol. I said Dad are we flying to Lyon again for a meal by Paul Bocuse? He said if they are vaccinated and we can sit on the veranda again we should do it again - I almost died laughing. Have a great day..............
The only ones that bought at .005 are gone and dead. PMCB just raised 85 million dollars at $5.00 read the filings with the SEC. Also the filings that someone said are sellers no there not. Read the filing its the options that insiders are BUYING... BUYING BUYING https://ir.pharmacyte.com/all-sec-filings/content/0001683168-21-003825/ownership.html https://ir.pharmacyte.com/all-sec-filings/content/0001683168-21-003826/ownership.html LOL how can anyone think this filing is a seller lol???
Also watch PMCB run up . There are not many days Wall Street gives a gift to the laymen but if you bought today its a no risk buy. Good news is coming and I think quick. My friends dont put up 80 million dollars if things arent going to get really good fast. Have a great day.............
read todays filing with the SEC its a done deal at $5.00
A positive write up on PMCB from seeking alpha that is very different than the past writes up
https://seekingalpha.com/article/4451013-pharmacyte-biotech-buy-the-dump?mail_subject=pmcb-pharmacyte-biotech-buy-the-dump&utm_campaign=rta-stock-article&utm_content=link-2&utm_medium=email&utm_source=seeking_alpha
Anthony Cataldo
6.64K Followers
PharmaCyte Biotech: Buy The 'Dump'
"I recommend that you nibble a few shares of PharmaCyte Biotech if interested in a “trade” or a very high-risk long-term buy-and-hold."
"If the investment community can be convinced that the PharmaCyte drug pipeline shows promise, it is not inconceivable that a large pharmaceutical may exhibit some interest - preferably financial interest or partnering interest. This could be very rewarding to shareholders choosing to enter at current PPS levels. I am willing to accept the risk/reward, at least for a few quarters and until I can re-evaluate the firm's cash burn and fundamentals."
https://seekingalpha.com/article/4451013-pharmacyte-biotech-buy-the-dump?mail_subject=pmcb-pharmacyte-biotech-buy-the-dump&utm_campaign=rta-stock-article&utm_content=link-2&utm_medium=email&utm_source=seeking_alpha
Anthony Cataldo
6.64K Followers
PharmaCyte Biotech: Buy The 'Dump'
"I recommend that you nibble a few shares of PharmaCyte Biotech if interested in a “trade” or a very high-risk long-term buy-and-hold."
"If the investment community can be convinced that the PharmaCyte drug pipeline shows promise, it is not inconceivable that a large pharmaceutical may exhibit some interest - preferably financial interest or partnering interest. This could be very rewarding to shareholders choosing to enter at current PPS levels. I am willing to accept the risk/reward, at least for a few quarters and until I can re-evaluate the firm's cash burn and fundamentals."
Well picked up a chunk this morning lets see how the future goes for PMCB now that we have plenty of cash in the bank and strong institutional $ that will support their deal. Last time I told others to buy under 3.00 well those that did made a huge return in 5 days if they we smart. Rememeber buy the dips and sell the rips. we can see $5.00 next week IMO. Have a great weekend
Great day for PMCB and all the people that were able to buy after the split... If you did you got PAID today. Now lets move forward and get the IND approved. Not much left to complete being we know all the FDA wants to lets us start our trial. With Dr. Hidalgo on top of things I feel we will be good and the price will reflect that. It looks like people with bigger pockets think the same 228 million shares is something to be very excited about imo. Have a great day................
lol I bought 38k under 3.00 do the math-- I put a few 1000 into TMDI around the 1.50 level just so I can flip it and short it against the box. When TMDI is ready to run I will stop shorting until then its buy under 1.55 and short it above 1.80 back and forth day after day until they either go under with MDT walking away or they decide to invest more. As of today it doesnt look like its better than Da Vinci but lol what do I know?????Have a great day I know I did....
11.05 in the after market already yes Diana its a very good day for some of us....
a buy signal kicked again at 6.95 but I didnt post it because if you want to play u have to pay.... Boy did we get paid today thank you PMCB. Dont be surprised with $20 -30 next week on some very good news. A new way to treat solid tumors is worth BILLIONS
Well I am so glad I bought a huge amount of shares and posted it when I did . A huge day for me and others that listened to me and bought PMCB under 3.00.. Do the math lol. the best thing is the rally here just started. the good news that will flow in the future will pop PMCB 10 fold from here Watch and see..
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cleaned up that seller for 25k today. Lets see what takes place going forward. Id like to see Kw pr if we got the full 15 million to move forward with our trial. KW show us what we got. Those that buy this kaos imo will be rewarded huge once the trial for PC starts. These new shares are the way to make the money. Have a great day and let PMCB show the world our treatment to save lives for cancer and diabetes."
Have a great day and listen to people in the know not those that havent a clue
Not odd at all it feels like BMY or another big pharma took a large stake in PMCB and they feel it will go much higher.I feel it will too. The float has been taken today and I wouldnt be surprised to a see a filing in the coming days. The new way to treat solid tumors is worth billions. One also should know what that could mean for Diabetes. If we prove it works and is safe I would say PMCB will change the future of Medicine and that is worth BILLIONS
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology is being used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s product candidate 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 to the patient’s tumor as close as possible to the site of the tumor. Once implanted, the chemotherapy prodrug ifosfamide that is normally activated in the liver is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy prodrug ifosfamide at the site of the cancer.
PharmaCyte’s product candidate for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation of the cell lines will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a “bio-artificial pancreas” for purposes of insulin production.
lol I threw in some money today into TMDI from the huge score I made on my huge holdings that is up 160% today with huge volume. TMDI could move up a bit but not anytime soon like my other one that exploded as it was bashed.I can now short TMDI against the box anytime I want.I might even have my son trade this for me. Have a great day lol
"LMAO….tomorrow will be $2.5 and lower low" LMAO .PMCB has traded amazing volume and has made a huge move up today lets see what the news to come is. Did the IND get the thumbs up? Feels like it did or maybe BMY made a investment in PMCB we do have Dr. Hidalgo that sits on their board and ours. You dont trade 154 million shares to the upside unless something really good has happened behind closed doors. LOL us lil guys are the last to find out but the volume and price movement gives us a hint of great things to come.....
Watch what happens when we trade over *8.00 again it will be halted to the upside and then open above 9.00+ have a great day the fun hasnt even started yet. PMCB will get the IND lifted and help save lives
No one thought this could happen well you havent seen NOTHING yet $40-50 $$$$ on the IND news being lifted . There are no shares for any shorts that got caught lol I love it. Anyone that listened and bought under 3.00 with me has to be happy today. Just sit back and watch this unfold to new highs in the coming days
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.
feels like the IND has been lifted by todays amount of buying. 95 million (by 10;30) shares someone knows something good imo new highs are coming . We could see $40-50 $ if there is news on the IND KABOOM we got the vol and we just got halted again to the upside at the HIGHS. Like I said the other day Buy under 3.00 and then you will make huge Money when the news starts top flow.
NASD on the halt is showing a 15.00 bid
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: PMCB) 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.
Dr.Manuel Hidalgo on PMCB
Professor of Medicine. Chief of Hem/Onc at Weill Cornell Medicine/New York Presbyterian Hospital. Pancreatic cancer researcher.
Dr. Hidalgo expanded the list of possibilities saying, “As this technology is extremely versatile in the sense that different cell types with different genetic manipulations can be used, the range of cancer types that can be treated is vast. It is envisioned that this clinical trial will open the opportunity to explore the same technology in other hard-to-treat cancers like liver, cholangiocarcinoma, head and neck cancer, brain tumors and others. Furthermore, the range of cells that can be encapsulated in Cell-in-a-Box® as well as the genetic modifications that can be made to these cells is just huge.”And the list doesn’t stop there. In addition to potential treatments for a number of cancers and for diabetes using different types of cells, the list of treatments grows exponentially when we discuss stem cells. In addition to encapsulating stem cells to treat diabetes, the encapsulation of stem cells can also be used to regenerate and repair diseased or damaged tissues in patients. These stem cell therapies are available for people with spinal cord injuries, Parkinson’s disease, Alzheimer’s disease, heart disease, strokes, burns and even cancer.Researchers continue to develop new ways in which stem cells can be conducive to better regenerative medicine approaches, to be eventually applied in transplants. Again, protecting stem cells using PharmaCyte’s technology would solve the long-standing concern over safety and efficacy of stem cell therapy to treat diseases and conditions of organs and tissues in patients.Today’s healthcare market offers few effective ways to treat the root causes of many diseases or conditions. In many cases, typical treatments can only manage a patients’ symptoms with medications or devices, providing only temporary symptomatic relief.PharmaCyte’s CEO believes that validating Cell-in-a-Box® will open many doors to the future of cellular therapies for his company. “What PharmaCyte is involved with can lead to a game-changing approach to treating numerous degenerative diseases. By encapsulating certain types of stem cells and protecting them, the body is given a chance to heal itself. This type of therapy is the future of medicine—medicine that offers the realistic promise of repairing damaged tissue and reversing the effects of many degenerative conditions, offering solutions for people with diseases that today are beyond repair.”
Its a beautiful thing seeing PMCB all over the Tape this morning . One of the most active pre market 5.5 million shares at 8;05. When I said the way to make money is to buy this under 3.00 lmao I DID and friends did too.. My phone hasnt stopped ringing this morning
PharmaCyte Biotech (NASDAQ:PMCB) shares rose 71.92% to $5.88 during Wednesday's pre-market session. The market value of their outstanding shares is at $9.4 million
Well that was nice PMCB just traded up to $4.45 pre market on 200k shares already. I sold 5000 @4.30 not bad for a morning at 7:10 ill buy some back soon. caChing. Have a great day
another 13 mins and our volume is up to500k. It should be a big volume day today with a nice up move
Boom we just hit 5.13
Buyers will come when PMCB hits $10 and buy more at $15-$20 for sure and then wait when it hits $35.00 and another bit of news to get it to $40.00 and then wait for it to hit $50.00 and then sell it $65.00 and then when it hits $80.00 All this happening as they find a new way to treat solid tumors. Then open the world for diabetes with cell In the Box. Love it make millions and treat Cancer...