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$PMCB PharmaCyte Biotech Raises Additional $1 Million for Pancreatic Cancer Clinical Trial
SILVER SPRING, Md., Jan. 14, 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®, announced today that the Company raised an additional $1 million. A Form 8-K was filed yesterday with the SEC providing the details of the capital raise. PharmaCyte has shown repeatedly the ability to raise the funds necessary to get into a pancreatic cancer clinical trial and to continue its work in both pancreatic cancer and diabetes.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We have a lot of work ahead of us this year at PharmaCyte. With the recently announced private placement of just over $1 million, we have not only increased our cash on hand to over $3.0 million but have increased our leverage in the capital markets. What is mission critical for PharmaCyte is getting into a pancreatic cancer clinical trial and producing the data that is necessary for us to approach the FDA. We have every expectation that will occur this year.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed.
PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.
In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate 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. The encapsulation will be done using the Cell-in-a-Box® technology.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions, as they relate to PharmaCyte Biotech or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte Biotech, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte Biotech’s intellectual property and PharmaCyte Biotech’s continued ability to raise capital. PharmaCyte Biotech does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
$ACTL added some 2's. Only 750 mil a/s and 415 mil o/s. Shares now are in stronger hands. The push north could be real nice..imo
COBI decrease in authorized now reflected on OTC .. merger coming
Compass Biotechnologies to Decrease Authorized Share Limit and General Update
http://www.otcmarkets.com/stock/COBI/news
$ACTL .0003 BMAK has moved to .018 cents. Looks like he is finished.
$ACTL .0003 Lots of buys here. 36 mil volume so far today. 4's up soon with only 17 mil there. Only 750 mil a/s and 415 mil o/s.
$PMCB Cell Encapsulation for Drug Delivery & Disease Treatment
http://www.pharmacytebiotech.com/wp-content/uploads/2015/01/Cellular-Microencapsulation.pdf
Go $PMCB
$ACTL .0003 GOOD CANDIDATE FOR BUYOUT...imo
Good chance this runs to high trips and 00's..imo
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120158874&txt2find=actl
750 Mil A/S and 415 Mil O/S
2 13g filings this month and 8k last month with someone taking a big stake in the company.
http://www.otcmarkets.com/stock/ACTL/filings
$PMCB Pharmacyte Biotech is About to Light the Fuse
Pharmacyte Biotech Inc. (OTCMKTS:PMCB) CEO Ken Waggoner is about to shake hands with a small army of movers and shakers.
Don't be too surprised if things seem a little more lively for Pharmacyte Biotech Inc. (OTCMKTS:PMCB) beginning next week.... trading activity, media coverage, and maybe even a partner or financial backer. The company's CEO Kenneth L. Waggoner will be attending this year's annual J.P. Morgan Healthcare Conference, which always seems to stir the pot, so to speak, for the company's in attendance. PMCB isn't apt to be an exception.
The invitation-only event pulls together institutional investors and biotech companies, and has become a much bigger event than J.P. Morgan ever foresaw when it started hosting the conference more than three decades ago. Now the entire area around the conference also hosts several other ancillary events that ultimate lead to deals, funding, and networking.
This year's conference will take place between January 11th and the 14th in San Francisco, California.
The event could prove to be a real boon for Pharmacyte Biotech, as it's headed into the event well-positioned with a tremendous pipeline and market opportunity.
PharmaCyte Biotech is the developer of a patented technology called Cell-in-a-Box(r) ... a means of encapsulating live cells -- cells grown to perform a particular function -- and implanting these pinhead-sized capsules in the body to perform a specific medical purpose. The technology has many applications, but PharmaCyte Biotech is furthest along in its development of the idea as a means of treating pancreatic cancer.
In phase 2 trials, PharmaCyte has shown that catalyzing a prodrug form of cancer-fighting therapy ifosfamide in the bloodstream in the upper part of the leg maximizes delivery of the active form of the drug to the cancer-ridden pancreas. Ergo, this approach has proven superior to activation of the drug in the liver.
In a phase 1/2 trial examining the benefit of the Cell-in-a-Box(r) activation of ifosfamide versus the results gemcitabine would be able to achieve alone, the Pharmacyte approach improved the median survival timeframe from 28 to 44 weeks. Equally impressive is the fact that the number of one-year survivors increased from 18% to 36% of the study's patients. The next stage of the trial will pit ifosfamide against the gemcitabine/Abraxane combination, which is the proverbial gold standard (for now) among pancreatic cancer treatment options.
The real star of the show, however, is the Cell-in-a-Box(r) technology, which makes the activation of ifosfamide possible.
As was noted, inside each encapsulation are thousands of living cells, engineered to take on a very specific role. In the case of pancreatic cancer, PharmaCyte Biotech has enclosed cells that produce the same P450 enzyme the liver would produce to activate ifosfamide. The only difference is the point of activation -- the leg rather than the liver.
Those who've followed the premise of live-cell encapsulation will know it's not been an easy road to navigate. The ideal material for the "shell" of these encapsulations is a cellulose-based material, but most trials of various cellulose materials have failed in the sense that either the body's immune system successfully attacked them (seeing these cells as outside invaders) , or the encapsulations themselves structurally failed.
PharmaCyte Biotech, however, seems to have found the right formula to make the encapsulations.
The combination of two proprietary polymers and a propriety droplet-forming process has allowed the company to achieve what had been fairly elusive for other researchers up until this point. The hardened polymer combination is still cellulose-based, allowing it to let nutrients in and allow the P450 enzyme out. But, the tough shell also prevents the patient's own immune system from attacking and killing the cells living inside the capsules.
Clearly the technology and premise have the potential to be a game-changer in terms of drug delivery, as the Cell-in-a-Box(r) technology can encapsulate a wide variety of cells....and not just cells that help fight cancer. PharmaCyte Biotech is even working on using encapsulate insulin-producing cells as a therapy for diabetes. Even then, the application of the idea has only scratched the surface of its potential.
There's no word yet on if PharmaCyte will be offering an online webcast from any presentations it makes at the conference, but it's very likely the company will be releasing some sort of update or wrap-up report after the event. More important though, it's a chance to get its story out in front of Wall Street's and the biotech industry's most centers of influence, which bodes well for PMCB shares (which have already been on a tear following last week's capitulation).
ADMD- clearly people using scare tactic to accumulating for low share and waiting on FDA news to come.
Advanced Medical Isotope Corporation Reports Progress Towards Seeking FDA Clearance for the Y-90 RadioGel™ Device
KENNEWICK, Wash.--(BUSINESS WIRE)--Advanced Medical Isotope Corporation ('AMIC') (OTC: ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications, ...
http://www.noodls.com/view/A775BABDD2CBF309508910335B19958BDCF843F6
$MJMJ 134 mil volume today! Whales loading up! imo
$ACTL .0003 750 Mil A/S and 330 Mil o/S. Way Oversold and Undervalued..imo
$MJMJ .0004 Is another good MJ play here making nice Revs! imo
~ MJMJ = Load da 4's!!
$PMCB Scientists have created insulin-producing cells that could replace injections
Australian scientists from the University of Technology, Sydney (UTS), have created a line of insulin-producing cells that could eliminate the need for Type 1 diabetics to inject themselves with insulin.
The development on its own is pretty impressive, but the cells, which are derived from liver cells, are now on their way to being incorporated to a world-first bio-artificial pancreas after being licensed by US biotechnology company PharmaCyte Biotech last October.
PharmaCyte Biotech has already acquired something called the Cell-in-a-Box® system, which is basically a tiny cellulose-based ‘capsule’ that can house artificial cells and integrate them into a human body. This platform can be used to develop treatments for any disease where cells aren’t releasing the molecules they’re supposed to, but after acquiring the license to the insulin-producing cells, it’s clear that PharmaCyte Biotech has set their sites on targeting Type 1 diabetes.
Type 1 diabetes or juvenile-onset diabetes is an autoimmune disease that occurs when a person’s immune system attacks their pancreas’s islet cells and prevents it from properly regulating the body’s blood glucose levels by releasing insulin.
The new cell line, called “Melligen” cells, is derived from human liver cells, which have been genetically modified to take over the role of the pancreas’s insulin-producing islet cells.
“When a foetus develops, the liver and the pancreas form from the same endodermal origin,” explained Ann Simpson from UTS:Science, who has been developing the cells over the past 20 years, in a press release. Which means that they should have the potential to do the same things as one another.
Early lab trials have shown that the genetically modified Melligen cells are able to release insulin in direct response to the amount of glucose in their surroundings – something that could help type 1 diabetics to live without daily injections and regulate their blood sugar levels naturally.
“My team and I are excited by the prospect of working with PharmaCyte Biotech to eliminate daily injections for insulin-dependent diabetic patients,” said Simpson in the release.
The next step for the company is for PharmaCyte Biotech to embed clusters of the Melligen cells into the Cell-in-a-Box® capsule, which is around the size of a pin head.
These artificial pancreases will then be transplanted into animals to test whether they can effectively integrate into the body and regulate insulin levels. After that, they can begin testing the technology in humans.
Several other groups are now working on artificial pancreases that use sensors under the skin, or even temporary tattoos to monitor blood glucose levels. But these systems all require a pump to control the amount of insulin required in response to these levels, rather than biologically sensitive cells.
It’s pretty exciting to see all the ground-breaking work on diabetes and insulin-producing cells finally be commercialized into a product that could directly change people’s lives.
—
Learn more here http://austrianova.com/healthcare/
$ACTL 3's going here. Looks like BMAK is out as he is not on the Ask. 750 mil A/S annd 330 Mil O/S.
ADMD DD package!
Tue, 15 Dec 2015 14:08:07 GMT ~ Advanced Medical Isotope Corporation Reports Progress Towards Seeking FDA Clearance for the Y-90 RadioGel™ Device
[at noodls] - KENNEWICK, Wash.--(BUSINESS WIRE)--Advanced Medical Isotope Corporation ('AMIC') (OTC: ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications, ...
read full:http://www.noodls.com/view/A775BABDD2CBF309508910335B19958BDCF843F6
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Tue, 15 Dec 2015 12:40:15 GMT ~ Is It Time To Buy Angle plc & Advanced Medical Solutions Group plc?
read full: http://uk.finance.yahoo.com/news/time-buy-angle-plc-advanced-124015121.html
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Tue, 15 Dec 2015 12:40:15 GMT ~ Is It Time To Buy Angle plc & Advanced Medical Solutions Group plc?
read full: http://www.fool.co.uk/investing/2015/12/15/is-it-time-to-buy-angle-plc-advanced-medical-solutions-group-plc/?source=uptyholnk3030001
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Tue, 08 Dec 2015 18:17:59 GMT ~ ADVANCED MEDICAL ISOTOPE CORP Financials
read full: http://finance.yahoo.com/q/is?s=admd
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Wed, 25 Nov 2015 13:02:23 GMT ~ ADVANCED MEDICAL ISOTOPE CORP Files SEC form 10-Q/A, Quarterly Report
read full: http://biz.yahoo.com/e/151125/admd10-q_a.html
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$ADMD company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/ADMD/company-info
Ticker: $ADMD
OTC Market Place: OTC Pink Current
CIK code: 0001449349
Company name: Advanced Medical Isotope Corp.
Company website: http://www.isotopeworld.com
Incorporated In: DE, USA
Business Description: Produces and distributes medical isotopes.
$ADMD share structure
## source: otcmarkets.com
Market Value: $4,193,562 a/o Jan 15, 2016
Shares Outstanding: 1,996,934,122 a/o Aug 14, 2015
Float: 18,749,307 a/o Sep 30, 2012
Authorized Shares: 200,000,000 a/o Sep 30, 2012
Par Value: 0.001
$ACTL .0004 Almost GO TIME Folks!! imo
$APYP nice close and up 22.2% today
$APYP 750MILL A/S 25MIL FLOAT.. QB STOCK WITH NEWS PENDING..
$ACTL .0004 Onlly 330 Mil o/s and 750 Mil A/S. Dilution almost done! This can run to 00's!! Imo
DOUGHBOYZ $TSOI GET ON THIS!! monster 8k out meat and potatoes in the link >>>
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11122066
Therapeutic Solutions International, Inc., (PINK:TSOI) announced today the signing of an exclusive intellectual property license agreement with Gustave Roussy Transfert of Villejuif, France for an issued U.S. patent covering the clinically tested “Dexosome” cancer immunotherapy product.
btw ceo and cfo acquired about half the common OS in 2014 at .002 and .003 as can be seen in form 4s
$PMCB PharmaCyte Biotech (PMCB) is locked and loaded -- money-wise -- for a while, funded to begin the next phase of its pancreatic cancer trial. The press release was posted this morning -- PMCB pocketed $1 million via the sale of equity, bringing its cash balance up to $3 million. That should get the company pretty far down the R&D road.
As impressive as garnering a million bucks worth of funding in this environment is, I think the real story with PMCB is the chart itself.
Some of you may recall we figured the sharp, high volume selloff from December 31st was a capitulation, and the beginning of a rebound move. We still have every reason to think that. Although the stock stalled as it approached the 50-day moving average line (purple), the 20-day line (blue) has since stepped up as a floor. It even looks like the bulls are trying to use the 20-day moving average line as something of a springboard. One good push above $0.08 could ignite another round of buying.
$PMCB PharmaCyte’s Innovative Platform Now Set to Target Multiple Deadly Cancers
Recent company news is a strong reminder that the potential value of the PharmaCyte Biotech (OTCQB – PMCB - $0.07 – Spec Buy) Cell-in-a-Box® platform technology is in the billions since it has proven to be effective in treating varying forms of cancer in preclinical and clinical tests. In fact, the Company’s platform could be potentially used to treat over 265,000 new patients suffering from varying forms of abdominal cancer and the 232,000 new patients diagnosed with breast cancer each year.
Abdominal Cancers
According to the American Cancer Society, hundreds of thousands of new cases of abdominal cancers in the U.S. are diagnosed annually. These include but are not limited to:
Colorectal: 132,000
Liver: 62,000
Pancreatic: 49,000
Ovarian: 22,000
To date, PharmaCyte’s live cell encapsulation technology, known as “Cell-in-a-Box®”, plus low-dose ifosfamide has successfully completed mid-stage clinical trials in pancreatic cancer. PharmaCyte could be just months away from a pre-IND meeting with the FDA to discuss plans for the next stage of clinical trials. Leveraging the solid results from completed trials and studies with PharmaCyte’s platform technology, PharmaCyte initiated preclinical studies designed to determine the effectiveness of Cell-in-a-Box® plus ifosfamide therapy in delaying the accumulation of malignant ascites fluid in the abdomen of mice with abdominal tumors.
PharmaCyte’s initial series of preclinical studies were conducted with mice that had been inoculated with a human ovarian cancer. The data is being used as a foundation for future studies on other tumor types. For example, the results from PharmaCyte’s 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 fact, the new study is based upon the results of previous work using this same model system that was performed by Dr. Matthias Löhr, the Chairman of PharmaCyte’s Scientific Advisory Board, and his colleagues at the University of Heidelberg, Germany. The results of the previous study were reported in the scientific publication Cancer Gene Therapy in 2006.
PharmaCyte hopes to replicate the earlier study results which demonstrated that a combination of the Cell-in-a-Box® capsules and ifosfamide is effective in treating the spread of colon cancer that was caused by malignant ascites fluid. This fluid is produced by abdominal cancers and is largely responsible for the spread of cancer cells from the original tumor to other sites in the peritoneal cavity. According to management, if successful, PharmaCyte will have developed a treatment that will help combat the spread of abdominal tumors and reduce the suffering of cancer patients from the production of ascites fluid within the abdominal cavity.
Breast Cancer
PharmaCyte’s platform technology plus low-dose ifosfamide has also achieved enviable success in efforts to develop a treatment for one of the most high profile cancers that are attributed to well over 200,000 new cases annually - breast cancer. In fact, the medical journal PLOS One published a study in which a Phase I/II clinical trials was conducted in dogs with spontaneously occurring mammary tumors which produced stellar results. (http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0102061). It should be noted that this animal model is closely related to the development of breast cancer in humans. As one might expect, the study results were remarkably similar to the earlier human Phase I/II pancreatic cancer trial using PharmaCyte’s platform technology.
In the trial, which included 16 female dogs, cyclophosphamide was chosen as the pro-drug instead of the pro-drug the ifosfamide used in the earlier pancreatic trials. That is because cyclophosphamide is a standard chemotherapeutic agent used in combination with others for the treatment of mammary cancer in dogs as well as breast cancer in humans. Since both cyclophosphamide and ifosfamide are “sister” pro-drugs and are converted to their cancer-killing forms in the same way, the same type of encapsulated live cells were used in both the pancreatic and mammary cancer studies. As in the human pancreatic cancer trials, the capsules were well tolerated in the mammary cancer trials, with no major safety issues. Importantly, far greater tumor shrinkage was observed in those dogs treated with encapsulated cells as well as the pro-drug versus those receiving cyclophosphamide alone.
Interestingly, prior to receiving approval for Abraxane as a treatment for pancreatic cancer, Celgene (NASDAQ – CELG) was awarded FDA approval to use the treatment for breast cancer. Since breast cancer is easier to treat and has a much higher survival rate than pancreatic cancer, it is conceivable that if PharmaCyte is successful in garnering FDA approval for pancreatic cancer, a breast cancer treatment approval could be a slam dunk.
The bottom line? If the favorable data from previous trials and studies for multiple cancer indications are any indication of potential future results, PharmaCyte’s novel approach could emerge as one of the most effective and diverse cancer treatment platforms in the market for solid tumors of all kinds and could be worth billions of dollars.
Put these two tickers on your watch list-$DIDG-$MPIX! Both Lotto Plays! Super LOW A/S for both at .0001 each!
$DBMM Keep Your Eyes On This GEM!! 200 Mil A/S!!
Check UPZS another acquisition in 6 months. 27m float... Very thin ask... No dilution
I'm on it!! GO DOUGHBOYZ AND $ACTL!!
$PMCB Pharmacyte Biotech is About to Light the Fuse
Pharmacyte Biotech Inc. (OTCMKTS:PMCB) CEO Ken Waggoner is about to shake hands with a small army of movers and shakers.
Don't be too surprised if things seem a little more lively for Pharmacyte Biotech Inc. (OTCMKTS:PMCB) beginning next week.... trading activity, media coverage, and maybe even a partner or financial backer. The company's CEO Kenneth L. Waggoner will be attending this year's annual J.P. Morgan Healthcare Conference, which always seems to stir the pot, so to speak, for the company's in attendance. PMCB isn't apt to be an exception.
The invitation-only event pulls together institutional investors and biotech companies, and has become a much bigger event than J.P. Morgan ever foresaw when it started hosting the conference more than three decades ago. Now the entire area around the conference also hosts several other ancillary events that ultimate lead to deals, funding, and networking.
This year's conference will take place between January 11th and the 14th in San Francisco, California.
The event could prove to be a real boon for Pharmacyte Biotech, as it's headed into the event well-positioned with a tremendous pipeline and market opportunity.
PharmaCyte Biotech is the developer of a patented technology called Cell-in-a-Box(r) ... a means of encapsulating live cells -- cells grown to perform a particular function -- and implanting these pinhead-sized capsules in the body to perform a specific medical purpose. The technology has many applications, but PharmaCyte Biotech is furthest along in its development of the idea as a means of treating pancreatic cancer.
In phase 2 trials, PharmaCyte has shown that catalyzing a prodrug form of cancer-fighting therapy ifosfamide in the bloodstream in the upper part of the leg maximizes delivery of the active form of the drug to the cancer-ridden pancreas. Ergo, this approach has proven superior to activation of the drug in the liver.
In a phase 1/2 trial examining the benefit of the Cell-in-a-Box(r) activation of ifosfamide versus the results gemcitabine would be able to achieve alone, the Pharmacyte approach improved the median survival timeframe from 28 to 44 weeks. Equally impressive is the fact that the number of one-year survivors increased from 18% to 36% of the study's patients. The next stage of the trial will pit ifosfamide against the gemcitabine/Abraxane combination, which is the proverbial gold standard (for now) among pancreatic cancer treatment options.
The real star of the show, however, is the Cell-in-a-Box(r) technology, which makes the activation of ifosfamide possible.
As was noted, inside each encapsulation are thousands of living cells, engineered to take on a very specific role. In the case of pancreatic cancer, PharmaCyte Biotech has enclosed cells that produce the same P450 enzyme the liver would produce to activate ifosfamide. The only difference is the point of activation -- the leg rather than the liver.
Those who've followed the premise of live-cell encapsulation will know it's not been an easy road to navigate. The ideal material for the "shell" of these encapsulations is a cellulose-based material, but most trials of various cellulose materials have failed in the sense that either the body's immune system successfully attacked them (seeing these cells as outside invaders) , or the encapsulations themselves structurally failed.
PharmaCyte Biotech, however, seems to have found the right formula to make the encapsulations.
The combination of two proprietary polymers and a propriety droplet-forming process has allowed the company to achieve what had been fairly elusive for other researchers up until this point. The hardened polymer combination is still cellulose-based, allowing it to let nutrients in and allow the P450 enzyme out. But, the tough shell also prevents the patient's own immune system from attacking and killing the cells living inside the capsules.
Clearly the technology and premise have the potential to be a game-changer in terms of drug delivery, as the Cell-in-a-Box(r) technology can encapsulate a wide variety of cells....and not just cells that help fight cancer. PharmaCyte Biotech is even working on using encapsulate insulin-producing cells as a therapy for diabetes. Even then, the application of the idea has only scratched the surface of its potential.
There's no word yet on if PharmaCyte will be offering an online webcast from any presentations it makes at the conference, but it's very likely the company will be releasing some sort of update or wrap-up report after the event. More important though, it's a chance to get its story out in front of Wall Street's and the biotech industry's most centers of influence, which bodes well for PMCB shares (which have already been on a tear following last week's capitulation).
$ACTL LOADING ZONE....@.0005-7
$PMCB PharmaCyte Biotech End of Year Shareholder Update on Pancreatic Cancer and Diabetes Programs
SILVER SPRING, Md., Dec. 30, 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 a shareholder update on PharmaCyte’s pancreatic cancer and diabetes programs.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, highlighted the following developments since the Company’s last shareholder update:
PharmaCyte announced a complete redesign of its clinical trial in advanced pancreatic cancer. After consulting with world-renowned experts in the filed of pancreatic cancer; including, Dr. Mathias Löhr, Dr. Manuel Hidalgo, and experts at Translational Drug Development (TD2), PharmaCyte’s Phase 2b clinical trial was completely redesigned in an attempt to satisfy a critical unmet medical need that exists for patients with inoperable, but not metastatic, pancreatic cancer whose tumors no longer respond after 4 to 6 months of treatment with the current “gold standard” for the disease, the combination of Abraxane® plus gemcitabine. In most cases, therapy consisting of another chemotherapy agent plus radiation is given to such patients. However, the beneficial effects of these treatments are marginal at best.
The clinical trial will now be conducted in the United States by TD2 with study sites in both Europe and Australia.
Eligible patients will be randomly placed into two groups. Group 1 will receive PharmaCyte’s pancreatic cancer treatment of Cell-in-a-Box® plus low doses of ifosfamide. Group 2 will receive treatment with the combination of capecitabine + radiation.
The primary endpoints for the trial will be: (i) progression-free survival (PSF); and (ii) the side effects that occur in the patients. PSF is the time that elapses from the first day of treatment until the disease gets worse. The trial design also includes several secondary endpoints; the most important of which are: (i) the onset of pain and the patient’s need for pain medications; (ii) whether the inoperable tumors become operable as a result of the treatment; (iii) the change in tumor size; and (iv) the patients’ overall quality of life during the treatment.
PharmaCyte will now include in this trial the evaluation of its pancreatic cancer treatment on the treatment of pain, a severe consequence of pancreatic cancer. A separate clinical trial on pancreatic cancer pain is no longer necessary.
Regarding PharmaCyte’s work on ascites fluid production and accumulation, a series of additional preclinical studies has been initiated and are being continued by TD2. The initial studies using an ovarian tumor model in mice indicated that PharmaCyte’s pancreatic cancer treatment might have value in treating the malignant ascites fluid condition. These preclinical studies are now being continued with other abdominal tumor models, beginning with colon cancer, in an effort to better define the conditions under which PharmaCyte’s pancreatic cancer treatment can modulate the production or accumulation of malignant ascites fluid.
In late 2015, PharmaCyte obtained the Orphan Drug designation (ODD) for its pancreatic cancer treatment from the European Medicines Agency (EMA). With this designation, PharmaCyte now has ODD in Europe and the United States, which was obtained in late 2014 when the FDA granted the ODD to PharmaCyte. Obtaining the ODD allows for 10 years of marketing exclusivity in the European Union and 7 years of marketing exclusivity in the United States upon approval by the EMA and the FDA of PharmaCyte’s pancreatic cancer treatment.
PharmaCyte appointed Dr. Manuel Hidalgo as a member of its Scientific Advisory Board and as a consultant. For several years, Dr. Hidalgo worked closely with pancreatic cancer expert Dr. Daniel D. Von Hoff, Chief Development Officer of TD2. Recently, Dr. Hidalgo was appointed Head of Hematology and Oncology at the Beth Israel Deaconess Hospital in Boston, an institution that is affiliated with the renowned Dana-Farber Cancer Institute in Boston.
PharmaCyte contracted with Imaging Endpoints, one of America’s leading Contract Research Organizations for radiologic imaging, to perform the radiologic imaging that will be the cornerstone of many of the measurements conducted during the pancreatic cancer clinical trial.
Prior to the initiation of a clinical trial, an Investigational New Drug Application (IND) must be filed and reviewed by the FDA. A major part of the IND is a section termed “Chemistry, Manufacturing and Controls” or “CMC.” Within the CMC section, a pivotal portion describes the characteristics of the drug or treatment production facility and supplies supporting documentation to ensure that the facility meets cGMP standards. PharmaCyte retained CMC experts Chamow and Associates (Chamow) to assist in evaluating the facility in Bangkok, Thailand, that will produce and supply the Cell-in-a-Box® technology for PharmaCyte’s clinical trial, and in preparing the relevant portions of the CMC section of the IND for submission to the FDA and other regulatory agencies. PharmaCyte and TD2 are awaiting receipt of Chamow’s audit report to finalize the timeline for commencement of the clinical trial.
In November 2015, the second annual meeting of the international Diabetes Consortium was held in Vienna, Austria. Members of the Consortium presented results of studies done to date and finalized research plans for future studies. A video that discusses PharmaCyte’s diabetes program was filmed at the meeting and can be viewed at www.PharmaCyte.com/diabetes.
A guest at the meeting of the Diabetes Consortium was Prof. Dr. Hans-Peter Hammes, one of Europe’s leading authorities on diabetes and its complications. Dr. Hammes currently serves as Section Head of Endocrinology at the 5th Medical Department, University Medical Center Mannheim at the University of Heidelberg in Germany. Dr. Hammes received the prestigious Camillo Golgi Prize awarded at the 2015 meeting of the European Association for the Study of Diabetes. After attending the Diabetes Consortium meeting and becoming acquainted with the Consortium members, Dr. Hammes agreed to join PharmaCyte’s Scientific Advisory Board and become a member of the Consortium. Dr. Hammes also agreed to serve as a consultant to PharmaCyte.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed. PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.
In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate 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. The encapsulation will be done using the Cell-in-a-Box® technology.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
DCAC ON WATCH**********
NERG bottomed out ENERGY Stock. Potential 10 bagger here imho. Huge NASDAQ UPLISTING news yesterday and tons of more news to come. Really like these levels for a huge run up to PENNIES potential. Fyi it ran sub penny to .0025 in December! Reminds me somewhat of my EGYH sub penny to .03 last year!
$NERG
$PJET TICK GOES THE CLOCK FOLKS!!!
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RXMD
- NO TOXIC DEBT, NO DILUTION PERIOD
- YIELD SIGN REMOVED ON FRIDAY JAN 8TH
- 1 MIL + REVS PER MONTH
- 15 MIL + REVS PER YEAR
- DECEMBER REVENUES COMING SOON
RXMD Security Details
Share Structure
Market Value1 $6,653,614 a/o Jan 08, 2016
Authorized Shares 500,000,000 a/o Aug 06, 2015
Outstanding Shares 352,043,045 a/o Dec 09, 2015
-Restricted Not Available
-Unrestricted Not Available
Held at DTC Not Available
Float 306,833,938 a/o Dec 09, 2015
Par Value 0.0001
WATCHLIST....$ACTL $ADMD $AIHX $AXXE $BVAP $COBI $DIRV $HCTI $STSC $TINO
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O/S 704,330,491 as of 11/20/15
A/S 1,600,000,000 as of 9/30/15
http://nvsos.gov/sosentitysearch/corpActions.aspx?lx8nvq=kOvnRWzGXDuNK%252byzUB70lw%253d%253d&CorpName=HYBRID+COATING+TECHNOLOGIES+INC
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We are pleased to announce that Industrial Finishes & Systems has entered into a definitive exclusive national distribution agreement with Hybrid Coating Technologies (HCT) for several of HCT’s coating formulations. HCT has developed Green Polyurethane™, the first-ever modified hybrid polyurethane (currently used in coatings and paint) manufactured without the use of toxic isocyanates throughout the entire production process.
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$HCTI LIFE CHANGER TARGETS = MULTIPLE PENNIES DD COMPILED
BEFORE CONTINUING I WOULD LIKE TO PRESENT TO YOU THE MOST KNOWN SHARE STRUCTURE OF THIS COMPANY.
O/S 704,330,491 as of 11/20/15
A/S 1,600,000,000 as of 9/30/15
http://nvsos.gov/sosentitysearch/corpActions.aspx?lx8nvq=kOvnRWzGXDuNK%252byzUB70lw%253d%253d&CorpName=HYBRID+COATING+TECHNOLOGIES+INC
TPAC HAD A VERY SIMILAR SS AND RAN TO [color=BLUE]0064 ON JAN 6,2016[/color] this is just to prove how undervalued $HCTI
We are pleased to announce that Industrial Finishes & Systems has entered into a definitive exclusive national distribution agreement with Hybrid Coating Technologies (HCT) for several of HCT’s coating formulations. HCT has developed Green Polyurethane™, the first-ever modified hybrid polyurethane (currently used in coatings and paint) manufactured without the use of toxic isocyanates throughout the entire production process.
PLEASE NOTE THE EXTENSIVE LIST OF DISTRIBUTION CENTERS THIS COMPANY HAS. THIS DEAL IS HUGE AND BIGGER THAN WE ALL CAN IMAGINE
http://industrialfinishes.com/contact/distribution-centers/
http://industrialfinishes.com/markets/truegreenpoly/
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