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Everything left before the PC Trial... can be done and the start date be on time...they don't just sit back and wait for one thing at a time to be completed...I am sure there are many things going on at once...
the Pre-IND is not done until the facility is GMP...the facility information is put in the CMC part of the IND...
the IND application material is given to the FDA and the Pre-IND is usually done over the phone...if all is in order the application will be submitted for approval to start the trial...if no answer within 30 days...we start enrollment...
what takes a little time is getting the Pre-IND meeting...BUT...keep in mind with Von Hoff involved that time could be drastically shortened...just like our Orphan Drug Designation was...
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PROFILE
Steven Chamow, Ph.D., has more than 20 years of experience in biopharmaceutical product development. A principal consultant, he helps biotechnology companies to develop CMC strategies for products in development and lifecycle strategies for marketed products. Over his career, he contributed to the development of three marketed products (Avastin, Natrecor, Vectibix).
Previously, he served as Senior Vice President, CMC, at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Prior to Intradigm, Dr. Chamow was Vice President, Process Sciences, at Genitope Corporation and at Abgenix, Inc., (acquired by Amgen) where he built the company's process sciences department and co-lead the design and construction of Abgenix' award-winning mammalian cell production facility in Fremont, CA.
Before Abgenix, he served as Director of Biopharmaceutical Development at Scios, Inc., (acquired by J&J), and as a scientist and senior scientist in process development at Genentech, Inc. Dr. Chamow was educated at the University of California (UC Santa Cruz, B.A. in biology; UC Davis, Ph.D. in biochemistry), and completed postdoctoral training at the National Institutes of Health. Dr. Chamow is author or co-author of more than 45 scientific publications and patents and co-editor of a 1999 book entitled Antibody Fusion Proteins.
enough said...
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FDA APPROVAL FOR WHAT???
THE FACILITY WAS JUST FINISHED...
and btw...I didn't have to do homework on this...I already knew all of this from years of investing in bio stocks...
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The facility in Thailand is brand spanking new state of the art facility...built to meet or exceed the GMP requirements of the FDA...
cGMP...the c was added to remind accepting countries that all guidelines must be followed with latest and current production processes...
"the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards."
Again this is a brand new state of the art facility...
jeez...
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PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today reported that the encapsulation facility for its pancreatic cancer therapy is ready to manufacture PharmaCyte’s biologic product under current Good Manufacturing Practices (GMP) standards.
how much clearer could that be...aren't some people jumping the gun here...
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PHARMACYTE BIOTECH GMP COMPLIANT WITH FDA STANDARDS...
like I said some people will just have to live with this fact...next
ENGAGE WITH THE FDA...
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4/25/2016...Commissioned for GMP Manufacture PharmaCyte Biotech’s Live-Cell Encapsulation Facility is ready to go...NEXT ENGAGING WITH THE FDA...
Nothing is going to change the course...some people will just have to live with that...
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WELL PMCB DID IT...GOT GMP...
Like many out there thought we'd never get GMP and they even had a countdown to try to prove it... well they were wrong...
Just like they were about EMA Orphan Drug Designation they said we would never get...
Just like they were about FDA Orphan Drug Designation they said we would never get...
they were wrong...
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PMCB GOT GMP COMPLIANCE FOR THE FDA...this is a bigger deal than a lot of people have made it out to be...
don't be surprised if this does bring in bigger investors that might have been waiting on this...
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PMCB GMP COMPLIANT WITH THE FDA...NOW WE MOVE INTO HUMAN TRIAL...
while others try to paint the picture it's a pump and dump fraud and they're just sitting around eating bon bons... this proves they've been hard at work and spending money on a facility's gaining GMP compliance... not dumping shares to buy maserati's...
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Brian Salmons saying... "Both of the teams from Austrianova and Chamow worked together seamlessly and virtually nonstop to ensure that the facility is ready for GMP manufacture of PharmaCyte’s biologic product. We did so to enable PharmaCyte to reach the clinic with its novel therapy for pancreatic cancer at the earliest opportunity.”
awesome job...
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Chamow saying... "the facility is ready for GMP manufacture to produce the encapsulated cells that are a major part of PharmaCyte’s pancreatic cancer therapy.”...is big too...
Remember TD2 and Chamow & Associates (Chamow) will both prepare the CMC section of the application....
That is not KW saying it or Walter Gunzburg or some joe shmo...it's a CRO that does this for the FDA for a living...
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Little tiny PharmaCyte saying: "With the facility ready for cGMP manufacture, we are now in a position to engage with the FDA to discuss our clinical investigational plan and initiate our first clinical trial.”
that is HUGE...
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The company has hit all of its milestones under Ken Waggoner... and this is one more. Now as KW says...we engage with the FDA...
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FDA HERE WE COME...PHARMACYTE BIOTECH GMP COMPLIANT...
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GMP COMPLIANT...GREAT FOR PHARMACYTE BIOTECH...
"we are now in a position to engage with the FDA"
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PharmaCyte Biotech’s Live-Cell Encapsulation Facility is Commissioned for GMP Manufacture
SILVER SPRING, Md., April 25, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today reported that the encapsulation facility for its pancreatic cancer therapy is ready to manufacture PharmaCyte’s biologic product under current Good Manufacturing Practices (GMP) standards. The facility will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy. The assessment was issued by Chamow & Associates, the biopharmaceutical consulting firm that specializes in the inspection of facilities for GMP compliance.
Dr. Steven Chamow of Chamow & Associates stated, “Use of the live-cell encapsulation technology is very complex with many manufacturing steps and processes. GMP readiness of a biologic manufacturing facility such as the Bangkok site is no exception. In a relatively short period of time, with the relentless and determined cooperation we received from Austrianova, the facility is ready for GMP manufacture to produce the encapsulated cells that are a major part of PharmaCyte’s pancreatic cancer therapy.”
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are delighted to announce this exciting milestone in the development of our therapy for pancreatic cancer. This is a major step in generating the overall Chemistry, Manufacturing and Controls (CMC) information, which makes up a large part of the pre-IND package we will be submitting to the U.S. Food and Drug Administration (FDA). We would like to thank Chamow & Associates and Austrianova for completing this process. With the facility ready for cGMP manufacture, we are now in a position to engage with the FDA to discuss our clinical investigational plan and initiate our first clinical trial.”
Over the last few months, following an initial on-site audit of the facility by Chamow & Associates, numerous detailed documents were required to be prepared, reviewed and approved by Chamow. These documents include the quality management system manual and a variety of facility-related standard operating procedures (SOPs). In addition, all facility-related equipment has successfully completed the necessary Installation Qualifications (IQ) and Operational Qualifications (OQ).
Dr. Brian Salmons, the Chief Executive Officer of Austrianova, said, “We are exceedingly pleased that we were able to have our unique state-of-the-art live-cell encapsulation facility assessed as ready for GMP manufacture by Chamow & Associates. Both of the teams from Austrianova and Chamow worked together seamlessly and virtually nonstop to ensure that the facility is ready for GMP manufacture of PharmaCyte’s biologic product. We did so to enable PharmaCyte to reach the clinic with its novel therapy for pancreatic cancer at the earliest opportunity.”
The Austrianova facility will be used to encapsulate the genetically engineered live human cells that, together with low doses of the cancer prodrug ifosfamide, make up PharmaCyte’s pancreatic cancer therapy. PharmaCyte’s cancer therapy attacks the pancreas tumor with “targeted chemotherapy,” resulting in significant tumor shrinkage, the ability to convert some tumors from inoperable to operable, a reduction in the pain associated with the disease and an improvement to a patient’s overall quality of life.
PharmaCyte’s upcoming clinical trial in advanced inoperable pancreatic cancer involves placing the genetically modified live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. The prodrug is converted to its active form at the site of the tumor. In an earlier Phase 1/2 clinical trial, this “targeted chemotherapy” demonstrated far greater efficacy than the then “gold-standard” of care with no meaningful side-effects from the chemotherapy. Patients enrolled in PharmaCyte’s clinical trial will have non-metastatic, locally advanced and inoperable pancreatic cancer. They will be eligible for the trial if their tumors are either stable or progressing after 4-6 cycles of treatment with either of the two most commonly used chemotherapies for these cancers - the two-drug combination of Abraxane® plus gemcitabine or the four-drug combination known as FOLFIRINOX. PharmaCyte’s therapy will be compared in such patients with the current “standard of care,” which consists of the combination of the anticancer drug capecitabine plus radiation.
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THAT WAS NOT PHARMACYTE'S APPLICATION FOR ASCITES....
DD...
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and I among others will remember that prediction for PMCB along with the rest of them...
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I PREDICT cGMP SOON FOR PMCB...
AND THEN IND AND THEN THE START OF HUMAN TRIAL...
BETTER TO BUY IN NOW THAN LATER...
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good luck with your TRADE...
Yes along with all the penny traders involved with the stock because it is on the OTC...but what I do know about after investing in bio stocks for the last 5 or 6 years is the complaints about the dilution mean nothing...no small startup bio company doesn't dilute their stock to pay for studies and trials...anyone investing in these bios knows that...it is the comments from the traders that pop up non stop about that...among other things...
it means nothing to us longs...I can't say it any clearer...
good luck though with your TRADE...
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I have been on the board a lot longer than that...and many of the true longs have said that the pps of PMCB does not bother us because it will never stop getting messed with or go up until we are into our human trial...
unlike the traders we just buy more when the pps goes down...
good luck with your TRADE...
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WOW GREAT VIDEO on PharmaCyte Biotech's Diabetes Consortium...now everyone knows why a certain writer was at PMCB's International Consortium...
40 weeks down to 10 days for the mouse model....WOW....that is incredible....
YES IN AN ANIMAL...MOUSE...they did mouse study using Melligen cells and Austrianova's encapsulation before we even owned the rights to Cell in a Box for Diabetes and before PharmaCyte Biotech bought the rights to the Melligen Cells...Ann Simpson has been working on the Melligen cell line for a long time...
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I have read it...and they used Cell in a Box for even previous studies...of course they are using Cell in a Box in our mice studies...
a thesis in 2010 states in the abstract that
"Melligen cells were also tested for suitability for
implantation. They were encapsulated (AustriaNova, Singapore) and insulin secretion and glucose responsiveness were determined."
These were Ann Simpson's Melligen Cells in that study...
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What makes you think that the Melligen cells were not encapsulated...it doesn't say that the cells were not encapsulated ...this study was done as part of OUR DIABETES CONSORTIUM...their work is for CiaB...
"The study showed that Melligen cells are as safe as the cells that were encapsulated with the Cell-in-a-Box(R) technology and then used together with the cancer drug ifosfamide to treat patients with advanced pancreatic cancer in previously conducted clinical trials. This safety study is the first study in animals of the Melligen cells that has been done as part of the work of the international Diabetes Consortium."
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We have heard about testing of the Melligen Cells...
http://www.pharmacytebiotech.com/pharmacyte-biotechs-melligen-cells-prove-safe-in-first-preclinical-test/
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Why don't you try calling TD2 and ask anyone there if they have ever heard of PMCB...and make sure you talk to the right people...not just someone sitting at a lobby entrance answering the phone...and get back with us with an honest answer...
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I would think that if people read and comprehended today's PR they already KNOW that PharmaCyte Biotech is doing their own studies...
"Each of the preclinical studies in ascites are being conducted by Translational Drug Development (TD2) - the premier CRO in the United States specializing in oncology. TD2 is also the CRO conducting PharmaCyte’s upcoming clinical trial in advanced pancreatic cancer."
'PharmaCyte’s initial series of preclinical studies were done with mice that had been inoculated with a human ovarian cancer.'
'The data obtained from these studies provided information that is being used as a foundation for future studies on other tumor types.'
'The results from this initial series of studies are now being used in connection with new colon cancer studies that may prove to be effective in developing a treatment that delays the production of malignant ascites fluid in cancer patients.'
'In part because colon cancer is the most commonly diagnosed cancer of the digestive tract, a new preclinical study has just begun in mice that have been inoculated with the regularly used Colon 26 mouse model.'
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Now let's talk about what a TYPE 1 DIABETES treatment is worth that would totally eliminate shots or pills...oh yeah I know of one...
PharmaCyte Biotech's Cell in a Box for Diabetes....
and don't forget Cell in a Box for All Cancers....
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THERE ARE NO SHORT SELLERS AT THESE PRICES...they've covered...
PMCB’s total short interest was 100,200 shares in December as published by FINRA...
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LOOKS LIKE cGMP FOR PHARMACYTE BIOTECH IS COMING SOON.....
PharmaCyte Contractor Chamow & Associates to Visit Cell-in-a-Box® Encapsulation Facility in Bangkok, Thailand
SILVER SPRING, Md., Dec. 04, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that representatives from Chamow & Associates, the San Francisco Bay Area firm contracted to assist PharmaCyte in preparing the Chemistry, Manufacturing and Controls (CMC) section of the Investigational New Drug Application (IND) that will be submitted to the drug regulatory authorities before commencement of PharmaCyte’s pancreatic cancer clinical trial, will visit the Austrianova Cell-in-a-Box® encapsulation facility next week located in Bangkok, Thailand.
The purpose of the visit is to determine whether the facility meets current Good Manufacturing Practices (cGMP) standards and to develop the necessary CMC information that must be included in the IND PharmaCyte will be submitting to the U.S. Food & Drug Administration (FDA). The visit will also identify any additional work that must be accomplished at the facility before submitting the IND. The IND is the seminal document that must be acceptable to the FDA and to drug regulatory authorities in other countries where the clinical trial will be conducted. Its acceptance by such authorities is the final step before PharmaCyte’s clinical trial can begin.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, explained, “The visit by representatives of Chamow & Associates is extremely important for ensuring that the CMC section of the IND for our trial in pancreatic cancer is both complete and correct. By virtue of this visit and contributions from Chamow & Associates to our preparation of the IND, we are confident that this critical section of the IND will be acceptable to the FDA and other drug regulatory authorities.”
The Bangkok-based live-cell encapsulation facility will produce capsules with genetically modified live cells using the Cell-in-a-Box® technology that will be used as a new consolidation therapy for patients with inoperable, non-metastatic pancreatic cancer. The new consolidation therapy forms the basis for PharmaCyte’s upcoming clinical trial involving patients with pancreatic cancer whose tumors no longer respond after 4-6 months of treatment with gemcitabine plus Abraxane®, currently the “gold standard” of treatment for advanced inoperable pancreatic cancer.
One of the therapies frequently used for these patients consists of the combination of the anticancer drug capecitabine and x-radiation, a somewhat ineffective and toxic treatment for pancreatic cancer patients. PharmaCyte’s pancreatic cancer treatment will be compared to this combination therapy as a new consolidation therapy after gemcitabine and Abraxane® in patients whose inoperable tumors no longer respond to the gold standard. Progression-free survival and overall survival will be determined for each of the therapies being compared. In addition, the extent to which the comparative therapies can reduce inoperable tumors to become operable will be determined. The safety of the two treatments will be compared as will their effectiveness in ameliorating the pain that accompanies pancreatic cancer. The overall quality of life of the patients undergoing therapy will also be carefully studied.
looks like crow pie for 2
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Ken Waggoner is not misleading anything....PMCB IS A BIOTECH ...anyone that invests in biotechs knows what this means...
PMCB long...
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I expect we hear on PharmaCyte's cGMP very soon so just wandering after that what will the countdown be ...
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crow pie for one...
Maybe they didn't mention cGMP because today's PR was not about cGMP...it was about the EMA Orphan Drug Designation that a couple people on here said we would never get...lol
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EXACTLY BioNewton....and "In addition, the EMA provides special assistance in the development of PharmaCyte’s treatment for pancreatic cancer.'
LONG AND STRONG PMCB
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PharmaCyte Biotech Provides Link to Orphan Drug Designation for Its Pancreatic Cancer Treatment
http://ec.europa.eu/health/documents/community-register/html/o149.htm
that should be official enough for a couple of traders on here...
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PharmaCyte Biotech Provides Link to Orphan Drug Designation for Its Pancreatic Cancer Treatment
SILVER SPRING, Md., Nov. 24, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the European Commission has updated its website to reflect that PharmaCyte Biotech Europe Limited, a subsidiary of PharmaCyte Biotech, Inc., is the “sponsor” or holder of the Orphan Drug designation in Europe for PharmaCyte’s pancreatic cancer treatment.
The European Commission’s website is now available to verify that the Orphan Drug designation has been obtained by PharmaCyte. View the European Commission’s updated page here: http://ec.europa.eu/health/documents/community-register/html/o149.htm
PharmaCyte has been assured that the European Medicines Agency (EMA) is in the process of updating its records to reflect that PharmaCyte has obtained the Orphan Drug designation. Receiving the Orphan Drug designation in Europe for PharmaCyte’s pancreatic cancer treatment carries with it 10 years of marketing exclusivity in countries in the European Union. In addition, the EMA provides special assistance in the development of PharmaCyte’s treatment for pancreatic cancer.
The Orphan Drug designation in the European Union is given to drugs for life-threatening diseases with low prevalence, or that make it unlikely an investment in a drug would be cost justified to treat the life threatening disease, and that the drug has been shown to provide a significant benefit to patients being treated by the drug.
- See more at: http://globenewswire.com/news-release/2015/11/24/789994/0/en/PharmaCyte-Biotech-Provides-Link-to-Orphan-Drug-Designation-for-Its-Pancreatic-Cancer-Treatment.html#sthash.sIIpSQY1.dpuf
THEY ARE NOT THE ONES MAKING THE PPS GO DOWN ON PMCB LOL...WE ALL KNOW WHO THAT IS...
to say it is the world renowned doctors who believe in Cell in a Box and PharmaCyte Biotech is ludicrous...
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PMCB HAVING WORLD RENOWNED DOCTORS WITH DIABETES EXPERTISE IN THEIR CONSORTIUM THAT BELIEVE IN CELL IN A BOX AND PHARMACYTE BIOTECH...
I would not call that...how was it put "a hyped up no substance press release" oh yeah....
good luck with your TRADE
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