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BHGI: I am still here confident our ultimate financial goals will be attained.
I wish a Happy Memorial Day to those brave servicemen/women and their surviving families who made the ultimate sacrifice so that we can enjoy the freedoms and liberties we often take for granted, namely our unalienable rights of life, liberty, and the pursuit of happiness.
Time to reflect and give thanks...
$PMCB One step closer to curing diabetes
A human cell line genetically engineered to produce, store and release insulin in response to blood sugar levels in the human body could eliminate the need for daily injections for insulin-reliant diabetics.
Developed by UTS's Professor Ann Simpson and her team at the UTS Centre for Health Technologies, these insulin producing "Melligen" cells show promise as a possible cure for type 1 diabetes. This month, the team secured US patent protection for the cell line from the US Patent and Trademark Office.
"My team and I are extremely pleased that the US patent for the Melligen cells has been granted," says Simpson. "This takes us a step closer to releasing diabetics from the need to inject insulin daily and, more importantly, protecting them from the debilitating complications of the disease such as blindness, kidney failure and cardiovascular problems."
The group is now working with US clinical stage biotechnology company PharmaCyte Biotech to commercialise the research.
PharmaCyte specialises in the development of targeted treatments for cancer and diabetes using its signature live cell encapsulation technology. This technology, known as Cell-in-a-Box, is a key process in the commercialisation of the Melligen cell as a revolutionary treatment.
"This is a culmination of many years' work by our group and we look forward to working with PharmaCyte's Diabetes Consortium to utilise the Cell-in–a-Box technology to encapsulate the cells for preclinical trials aimed at curing diabetes," says Simpson.
"We anticipate that the capsule technology will protect the Melligen cells from the body's immune response that normally destroys foreign tissue, allowing the Melligen cells to be transplanted into humans."
PharmaCyte's Chief Executive Officer, Kenneth L Waggoner, says, "We at PharmaCyte consider ourselves to be very fortunate in having secured the exclusive world-wide licence to use the Melligen cells to develop a treatment for diabetes.
"If we are successful in this effort, it will bring to fruition the many years of research that have been conducted by Professor Simpson and her colleagues at UTS in developing these remarkable cells. Importantly, we are very pleased that Professor Simpson will be assisting PharmaCyte in this endeavour as a member of our International Diabetes Consortium.
"For the millions of people worldwide who suffer from a disease of epidemic proportions, our treatment could relieve them of the onerous daily requirements for insulin administration and dietary restrictions and offer a life free from the very serious and even life-threatening complications associated with diabetes."
With the World Health Organization attributing more than 1.5 million deaths to diabetes in 2012 and more than 422 million adults suffering from the disease in 2014, the development has the potential to impact millions of lives.
The cell line already has patent protection from the European counterpart to the US Patent and Trademark Office and the patent has been validated in France, Switzerland, Great Britain, Ireland, Germany, Spain, Denmark, Italy and the Netherlands.
http://m.medicalxpress.com/news/2016-05-closer-diabetes.html
GEQU
$PMCB The Exciting Story of Pharmacyte Biotech Inc (OTCMKTS:PMCB) Continues
Pharmacyte Biotech Inc (OTCMKTS:PMCB) closed at an intra-day high on breaking news that its encapsulation facility for pancreatic cancer therapy was deemed suitable by the FDA. This is a very bullish development. The stock has climbed past its highs set in mid-March of $0.074 and current trading at $0.077. It has developed a higher high and poised for more gains from current levels and should easily climb higher from current levels.
The encapsulation facility in Thailand that will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy has recently been inspected by the Food and Drug Administration of Thailand. Thai FDA stated through a report that, “The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products.”
The Chief Executive Officer stated, “We are very pleased that our partner, Austrianova, has received a positive opinion from the Thai FDA for Austrianova’s live-cell encapsulation facility. This is an important milestone in the development of PharmaCyte’s treatment for pancreatic cancer and a pre-requisite for our upcoming pancreatic cancer clinical trial.”
On April 6th PMCB announced it has changed its clinical trial design. This means that the actual date for the clinical trial is unknown at this point. While the new trial design offers PMCB a much better shot at success with FDA and EMA approval, it has also been an exercise in patience for the company’s leadership and its shareholders.
PMCB just released its financial information with the SEC according to a recent filing. PMCB is set to launch a new clinical trial sometime in 2016 for pancreatic cancer patients. There is a huge unmet medical need and people will welcome a solution that could potentially increase the lifespan for late stage pancreatic patients. If the clinical trial is successful, PMCB will be gaining more than just 50% to investors and likely cause the company to increase in value significantly and potentially be acquired by a larger pharmaceutical company.
Any positive results would move PMCB into the spotlight and above other early stage biotechs who are trying to come up with a solution as well. There would be a substantial increase in the company’s value and it would absolutely be able to attract major attention from large pharmaceutical companies. It would give a much needed viable option for pancreatic cancer treatment.
The market size for pancreatic cancer is huge. Looking only at major developed countries, the market size should reach close to $3 billion within the next 5 years. If we look at the addressable market that in the United States only is equally impressive, which PMCB should easily be able to attain. A typical drug price for this disease is roughly between $50k and $75k per year. There are about 43,000 patients diagnosed with pancreatic cancer a year. Assuming that 60% of the patient pool would switch to PMCBs drug, the market size in the USA could be estimated at $1.25 billion to $1.8 billion. Given the market valuation is only $51 million, a successful positive trail will send shares flying through the stratosphere.
PMCB is currently trading at a $64 million market valuation. PMCB is developing a revolutionary therapy that could provide relief to thousands of patients every year that are diagnosed. There is a huge market that PMCB will be able to successfully operate in if clinical trials yield positive results. Even though a fully FDA approved drug is likely a long way out, advances and positive news will send shares flying. Stay tuned for more updates.
We will be updating on PMCB when more details emerge so make sure you are subscribed to Microcapspot so you know what’s going on with PMCB .
Disclosure: we hold no position in PMCB either long or short and we have not been compensated for this article.
$PMCB PharmaCyte Biotech Clears Major Milestone on Path to FDA Clinical Trial
NEW YORK, NY--(Marketwired - May 05, 2016) - PharmaCyte Biotech (OTCQB: PMCB) has now reached a point in its life cycle where it is ready to start working with the U.S. FDA to get the company's Phase 2b clinical trial in advanced pancreatic cancer underway. Let that sink in for a moment. PharmaCyte's Chief Executive Officer, Kenneth L. Waggoner, has taken up the mantle to move the company's signature technology, Cell-in-a-Box®, to the clinic. And now, three short years later, he has the small biotech on the doorstep of what could be an eye-opening clinical trial to treat pancreatic cancer patients.
According to the American Cancer Society's cancer statistics for 2016, pancreatic cancer is the third leading cause of cancer-related deaths in the United States, and it's one of the few cancers for which survival has not improved substantially over nearly 40 years. But help could be on the way. After PharmaCyte announced last week that the live-cell encapsulation facility where its Cell-in-a-Box® capsules are produced is now current Good Manufacturing Practices or cGMP-compliant, the company cleared what was a major milestone on the way to a clinical trial and is now closer than ever to taking on the challenge of improving the lives of pancreatic cancer patients.
These are truly exciting times at PharmaCyte, and with the cell encapsulation facility now cGMP-compliant, the company can set its sights on first requesting a pre-IND (Investigational New Drug application) meeting with the FDA to discuss the design of its upcoming clinical trial.
This pre-IND meeting will be crucial to developing a relationship with the FDA and getting the necessary answers and guidance moving forward that will allow PharmaCyte to submit its formal IND to the FDA. The pre-IND meeting and the IND submission to the FDA are the next two major milestones for PharmaCyte and its investors.
With the encapsulation facility now ready for the production of clinical trial material, let's look at the trial design that PharmaCyte has announced for its Phase 2b clinical trial:
PharmaCyte's pancreatic cancer therapy consists of placing microcapsules containing genetically engineered live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. When the blood carries the chemotherapy drug to where the capsules have been placed, activation of the drug takes place right at the source of the cancer instead of in the patient's liver, which eliminates any side effects in these patients.
The trial will be a multi-site trial held in both the United States and Europe. It will also be an open-label trial in which the patients will be randomized between two study groups. The trial has been designed to meet a clear unmet medical need that exists for a particular group of pancreatic cancer patients.
The randomization ratio of patients between the two study groups will be 1:1 (an equal number of patients will be randomly assigned to the capecitabine + radiation group and the PharmaCyte pancreatic cancer therapy group).
Only patients who have locally advanced, non-metastatic, inoperable cancer and whose tumors no longer respond after 4-6 months of treatment with either the widely used Abraxane® + gemcitabine combination therapy or FOLFIRINOX, will be eligible for the trial. These patients are usually treated with the combination of the chemotherapy drug capecitabine + radiation, but this treatment is only marginally effective and is quite toxic for the patients.
Study sites under consideration in the U.S. include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute also in Boston, the Baylor Cancer Center in Dallas, Texas, Cedars-Sinai Medical Center in Los Angeles, as well as sites in Germany and Spain.
It is believed that 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
Unlike in earlier clinical trials using PharmaCyte's pancreatic cancer therapy where patients received only two cycles of therapy with ifosfamide, multiple cycles of ifosfamide will be given to those being treated with PharmaCyte's pancreatic cancer therapy. This will continue until the patients' tumors no longer respond to PharmaCyte's therapy or until treatment-related toxicity accumulates to unacceptable levels.
And the best news of all for investors heading into these exciting times is that PharmaCyte has been awarded the Orphan Drug designation by both the U.S. FDA and the European Medicines Agency (EMA). This designation means that the company's pancreatic cancer therapy will have complete protection and market exclusivity for years to come. After PharmaCyte's therapy is approved for marketing by these two regulatory agencies, they will enjoy 7 years of market exclusivity in the United States and 10 years of protection in the European Union.
PharmaCyte's CEO also recently stated that the company's pancreatic cancer therapy qualifies for 12 years of data exclusivity because it is considered a "biologic" as outlined by the Biologics Price Competition and Innovation Act (BPCIA).
So, as the company marches headlong into a Phase 2b clinical trial in the U.S. and Europe with a built in "hard stop" about half way through the trial to review the data, there is no better time than the present to get excited about this small biotechnology company and what could very well be a significant contribution to the treatment of pancreatic cancer.
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. PharmaCyte Biotech has not endorsed this article, and Stock Market Media Group was not compensated for its production.
Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB's filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.
We are not a registered broker, dealer, analyst, or advisor. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications about any of the companies we write about are not a recommendation to buy or sell a security.
For more information: www.stockmarketmediagroup.com.
$MMHC chart ... hit low so 0.0011 / lookin bouncy here
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$PMCB PharmaCyte Biotech Appoints Former Johnson & Johnson Executive as Senior Business Development Advisor
SILVER SPRING, Md., May 03, 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 announced that it has appointed Dr. Sanjay Batra as its Senior Business Development Advisor.
Dr. Sanjay Batra brings to PharmaCyte more than 20 years of global healthcare and entrepreneurial experience in start-ups, biotech and large pharma. Dr. Batra spent 10 years at Johnson & Johnson, culminating as Vice President, R&D Pharmaceuticals, Asia-Pacific and Japan. He is highly skilled in partnering with diverse stakeholders, such pharmaceutical companies, the investment community, academia and key opinion leaders. In addition, Dr. Batra has been involved in over 80 clinical trials in all phases of development and commercialization.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of Dr. Batra’s appointment, “We are pleased that Dr. Batra has agreed to join our team, as we now have a cGMP-compliant facility and are ready to enter into the next phase of our life-cycle as a biotech company. We believe that his experience at Johnson & Johnson and his global network will prove invaluable to PharmaCyte. His expertise in scientific, medical and business areas, both domestically and internationally, will be a key asset as we move PharmaCyte forward towards the successful development of our novel platform technology to treat pancreatic cancer and diabetes.”
Dr. Batra said, “I am very excited to be part of the PharmaCyte team at this pivotal time. The technology holds tremendous promise to help physicians and their patients in areas of significant unmet medical need. Mr. Waggoner has built a very solid organization, and I look forward to making contributions with pace and rigor to advance our product pipeline towards commercialization.”
Most recently, Dr. Batra served as President and CEO of Aesthetic Factors, an emerging company providing autologous, point-of-care therapies in Regenerative Medicine. In this role, Dr. Batra led the commercial growth of their platelet-rich plasma and autologous fat products and was instrumental in establishing the company as the science driven leader. In 2013, Dr. Batra founded VIAS Partners with the aspiration to take his diverse experiences and global network to partner with entrepreneurs and companies to advance their business concepts.
Dr. Batra obtained his Ph.D. in medical physiology from the University of Ottawa, Canada, and completed his post-doctoral training with world-renowned scientists in Japan and Switzerland. He is a Fellow of the American College of Cardiology and an Adjunct Professor at the Wake Forest Institute for Regenerative Medicine. Dr. Batra has published over 50 papers and 70 abstracts, and has made more than 100 invited scientific presentations.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company 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 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 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, a chemotherapy drug which needs to be activated in the body (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 the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the chemotherapy 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 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
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