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PharmaCyte Closing in on Submission of Crucial Investigational New Drug Application to Begin Clinical Trial in Pancreatic Cancer
The news I have been waiting for Pete...
May 21, 2018 09:20 ET | Source: PharmaCyte Biotech
NEW YORK, NY, May 21, 2018 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has reached the proverbial “home stretch” regarding its efforts to submit an Investigational New Drug Application (IND) to the U.S. FDA. It’s an IND that has been eagerly anticipated by the company’s shareholders since PharmaCyte met with the FDA in early 2017, and it would lay out PharmaCyte’s planned Phase 2b clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC.
The key to submitting the IND is and always has been satisfying regulatory requirements. In short, PharmaCyte must generate the necessary data that the FDA requires for any treatment—but especially a treatment that is deemed a “biologic” by the FDA and comprised of living cells that would be placed inside a human’s body.
PharmaCyte just announced that it has completed and passed 29 different tests from its Master Cell Bank (MCB), which is made up of cells that will be used in its planned clinical trial in patients with LAPC. The successful completion of these tests is the final hurdle before encapsulation and testing of the encapsulated cells can begin at Austrianova.
Vials of cells from the MCB have already been supplied to the company’s partner, Austrianova, for encapsulation. Austrianova will now be charged with completing the encapsulation process using PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box®, to create the thousands of capsules that will be necessary to conduct its planned clinical trial. Each capsule will contain 10,000 live cells, and then each syringe will be filled with 300 capsules—making up the finished product that will be sent to clinical trial sites.
The encapsulation process will be followed by a battery of tests that will generate the necessary data to satisfy regulatory requirements and should complete what has been a long, meticulous process and allow PharmaCyte to finally submit it’s IND to the FDA.
In addition to the 29 successful tests that PharmaCyte announced last week, the company has stated that a number of additional tests have also been a success (See www.PharmaCyte.com/news). This is all very good news for shareholders who have been clamoring for the start of a clinical trial, and it should bode well for a company that is trying to win the FDA’s approval when it does submit its IND.
PharmaCyte’s goal of starting a Phase 2b clinical trial to meet an unmet medical need in the treatment of patients with LAPC is a remarkable milestone for such a small company, and because their first ever trip inside the clinic involves presenting the FDA with a biologic treatment, the sheer complexity of this journey explains why the process has been so time consuming. PharmaCyte’s treatment for LAPC utilizes genetically engineered live human cells that produce a particularly potent cytochrome P450 enzyme that is able to activate the chemotherapy prodrug ifosfamide.
As previously mentioned, these cells are encapsulated using the Cell-in-a-Box® technology, and the tiny, pinhead-sized capsules are implanted near the cancerous tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor.
PharmaCyte’s treatment is not a single molecule drug. It’s not a drug at all actually. And because the treatment is made up of live human cells that are responsible for activating an already FDA-approved chemotherapy drug, the FDA expects every single cell to act exactly the same way, every single time, in every single test that PharmaCyte is required to conduct.
The FDA simply wants to know that the capsules and the cells that live inside them will remain exactly the same at all times when they are eventually placed inside the human body. And unfortunately there is no short cut when it comes to satisfying regulatory requirements.
The unmet medical need that PharmaCyte expects to address in its clinical trial is for those patients who no longer see any benefit from using the preferred standard of care, Abraxane® combined with gemcitabine, or FOLFIRINOX, another combination chemotherapy that is increasingly being used in the U.S. as the preferred standard of care. These patients must have tumors that no longer respond to these combination chemotherapies after they’ve been on the treatment for a period of between 4 and 6 months.
The good news for PharmaCyte’s patient shareholders is that the company has reached the “end of the line” in what has been a very long process. But, when it comes to the FDA and success in a clinical trial—especially for a small company like PharmaCyte—there is only one true shot at getting it right.
I like the complete baldness on some men. Haha
All is well Pete. Hope the same for you and yours... :)
Thanks for posting this abstract. This article was just written June 2017...
https://www.ncbi.nlm.nih.gov/pubmed/28614369
That is so cool... Thanks for the update...
Great post! Additionally, I think it is important to recognize that Ken Waggoner has been the catalyst for most or all of PharmaCyte's recent milestones.
He is a genius businessman and leader. It has been his ability to execute the common vision of all those involved.
He is very motivated as well. I believe he really wants to see a cure for PC, knowing his personal history.
Really good news Pete...
Patiently waiting for human trials... :)
I am invested in PharmaCyte Biotech and continue to believe that its Cell-in-a-Box technology is revolutionary.
Everyone has an opinion. This is mine. If I wanted to invest in another company, I can do the research myself. Lots of good companies out there doing lots of good things.
I choose this one, PMCB.
Very nice post...
Hello Bio... Good news lately... :)
Some good news lately...
Hey Pete! Thanks for sharing. I think this is the best PP presentation I have seen from them. It is very sophisticated with all the visuals.
:)
Doing well... Trading seems to be the usual pattern... Patiently awaiting the advent of trials...
Blessings...
$PMCB
Have you already seen this? I always like to see institutions showing interest.
http://www.nasdaq.com/symbol/pmcb/institutional-holdings
Thanks markiff. Hopefully, you will find your entry point at the right time.
GLTA. $PMCB
Yes it is...
Also, adding whenever possible...
Appreciate all the support and reminders...
Right o old chap! As our good friend Promise Land might say. :)
Thanks Pete...
ACCUMULATION is where I am at as well. I will just continue to buy whenever I can as long as I still believe. I am a believer still. Haha...
I tend to agree with you efood. Shorts have been masterful at keeping this down. I think it is going to take big money investors to get this really moving upward. I don't even know if it will be the start of trials as much as the 60 stop. That is when there will be no doubt and the shorts will not be able to hold it down. However, I also think PMCB could be bought out before the 60 day stop if any big pharma have NDEs with PMCB. All just my opinion based on my observations over the past three years...
$PMCB has my vote!
Agree Pete. It is good to hear news from our cannabis side of the business...
Hey, I wanted to wish you a Happy Belated Birthday Promised Land and isn't this some very good news... :)
“While this patent application should make our investors feel assured about the protection of our pancreas cancer therapy, they should understand that if our pancreas cancer therapy receives FDA approval, the orphan drug designation in the U.S. and the EU, together with the BPCIA data exclusivity, will give us substantial marketing exclusivity for our pancreas cancer therapy. This new patent application, while it does include our pancreas cancer therapy, should really be viewed as an opportunity to dramatically broaden PharmaCyte’s ability to protect our therapy for all malignant tumors for the next 20 years.” KW
Great post Brian! Thanks...
My sentiments exactly. Thanks for the post...
Very well stated... Thanks
Thanks for the post JD...
Pivotal Trial article... good info...
http://www.engineersjournal.ie/2015/04/07/medical-device-trials-design/
Very good news!
"KW has taken a treatment that had no direction and is on the cusp of helping make people's lives better. "
This is the part I have been waiting for! PMCB is "on the cusp of helping make people's lives better" and we get to witness and be a part of that process...
I am going to have to listen to the recording but I am hoping to pop in here from time to time to hear some of the goodies... Do share! :)
Just trying to time a good buy. I think there will be plenty of opportunities for a while the way this is notoriously traded for pennies. I plan to buy more and save for $$$...
Feeling very good about our prospects.
Me too, Rudy! Thanks for the article...
Awesome...
Awesome...
Big day today!
PharmaCyte Biotech is meeting with the U.S. FDA today to discuss our upcoming clinical trial in #PancreaticCancer - This meeting with the FDA's Center for Biologics Evaluation and Research (CBER) marks the culmination of years of hard work by the entire team of oncologists, clinicians, doctors and researchers that surrounds our pancreatic cancer therapy.
A special thanks to our partners at Austrianova for this amazing technology and pancreatic cancer therapy and for your dedication and hard work, and to our many dedicated shareholders who have helped to make this day possible - your patience is sincerely appreciated! We look forward to sharing the news from today's meeting with the public very soon.
FB
Happy 4 U!