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$PMCB Stonegate Capital Partners Publishes Research Report on PharmaCyte Biotech
SILVER SPRING, Md., Feb. 10, 2016 -- 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 Stonegate Capital Partners (Stonegate), a privately held corporate advisory firm based in Dallas, Texas, with offices in New York and Boston, issued a Research Report featuring PharmaCyte Biotech. The report can be viewed at http://stonegateinc.com/reports/Pharma_Feb_2016.pdf
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented on the report saying, “In our opinion the Research Report released by Stonegate Capital Partners and authored by Senior Research Analyst Laura S. Engel is comprehensive and captures the essence of what we are trying to accomplish at PharmaCyte. Particular emphasis is placed on the two major programs underway that employ our proprietary Cell-in-a-Box® live-cell encapsulation technology to tackle two of the most difficult to treat diseases in the world - cancer and diabetes.”
Stonegate’s Senior Research Analyst, Laura S. Engel, authored the Research Report, which focuses on PharmaCyte’s clinical development of a variety of potential therapies across several areas of disease utilizing its novel live cell encapsulation platform, Cell-in-a-Box®.
Stonegate’s Senior Research Analyst writes that PharmaCyte offers a significant opportunity for investors looking to participate in this development. “We believe that PMCB has a solid pathway towards commercialization with the approach outlined for its Phase 2b study for pancreatic cancer patients set to begin in the Q2-Q3 of calendar year 2016. Additionally, management will be actively moving other potential treatments along; these treatments are related to malignant ascites fluid accumulation in the abdomens of patients with abdominal cancers and Type 1 and Type 2 diabetes. Positive news flow should yield investor returns as the Company accomplishes its milestones that have been set for 2016.”
Senior Research Analyst Laura S. Engel started a career in public accounting following graduation from the University of Virginia, McIntire School of Business, with a B.S. in Accounting. After several years with Arthur Andersen, Engel transitioned in industry where she worked for several publicly traded companies, managing both domestic and international accounting operations. Engel subsequently transitioned into the finance realm, joining a Financial Services consulting team with KPMG Consulting focusing on systems implementations for several Wall Street banks. She later joined a smaller wealth management group, servicing a book of clientele through investment management and financial planning. Since 2003, Engel has teamed with Stonegate and worked in several areas of the business.
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, a chemotherapy drug which needs to be activated in the body (prodrug) 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 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
http://www.econotimes.com/Stonegate-Capital-Partners-Publishes-Research-Report-on-PharmaCyte-Biotech-158732
$PMCB Press Release
AUSTRIANOVA EXPANDS ITS BUSINESS AREA
JANUARY 26, 2016 EPR BIOTECH NEWS LEAVE A COMMENT
SINGAPORE, January 26, 2016 — /EPR BIOTECH NEWS/ — Austrianova announced today that, having completed the set up of austrianova logoits new GMP facility, it is now offering clients a GMP cell banking (Master Cell Bank and Working Cell Bank) as well as a “Fill and Finish” service for cell therapy products, in addition to its encapsulation services and technology. Austrianova is able to offer the production of Master Cell and Working Cell Banks (MCB and WCB) at the size scale required for early (phase 1 and 2) stage clinical trials at highly competitive prices using its state of the art isolator based production facility, assuring that the highest quality standards are adhered to. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells. MCB’s and WCB’s are required for all cell therapy products such as stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc. Similarly, many companies, including those developing stem cell lines and products, are seeking high quality economic fill and finish for relative small lots.
“We see this as a natural add-on to our already established Cell-in-a-Box® cell encapsulation technology for which we have recently set up a GMP manufacturing facility in Thailand. This kind of MCB and WCB production as well as “Fill and Finish” services for cells are, however, stand alone services. Although these services are generally available to all customers, they should allow start up companies and academic based cell products, vaccines etc to enter clinical trials in a quality assured manner but at lower cost that other, more conventional, cell banking companies offer” stated Walter H. Gunzburg, Chairman and CTO of Austrianova.
“In addition to our state of the art facility, Austrianova offers services that comply with major international regulatory agencies using a customized German/Swiss based quality assurance system. Our team has many years experience with regulatory agencies around the world and has taken cell therapies into clinical trials” said Brian Salmons, CEO.
More information about the GMP4Cells cell banking but also the Cell-in-a-Box® and the related Bac-in-a-Box® encapsulation services can be found on our newly revamped website www.austrianova.com.
About Austrianova:
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability for extending storage under lyophilized conditions and protection in stomach acid.
Austrianova Singapore Pte Ltd,
#05-19 Synapse,
3 Biopolis Drive,
Singapore 138623
Tel +65 6779 3867
Fax: +65 6268 4671
Austrianova Thailand Co., Ltd,
141 INC2 Building D, Room 401-404
Thailand Science Park,
Paholyothin Road, Klong 1,
Klong Luang, Pathumthani 12120,
Thailand
www.austrianova.com
http://www.eprbiotechnews.com/2016/01/26/austrianova-expands-its-business-area/
$PMCB PharmaCyte Executives Meet With Translational Drug Development to Advance Pancreatic Cancer Clinical Trial
January 25, 2016
SILVER SPRING, Md., Jan. 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®, announced today that its Chief Executive Officer, Kenneth L. Waggoner, and its Chief Operating Officer, Dr. Gerald W. Crabtree, recently met with principals of Translational Drug Development (TD2) at TD2’s facilities in Scottsdale, Arizona. The meeting was held to discuss a number of aspects related to PharmaCyte’s upcoming clinical trial in pancreatic cancer and the structure of the Investigational New Drug Application (IND) that must be submitted to the FDA and found acceptable before the clinical trial can begin. PharmaCyte has contracted with TD2 to be the lead Contract Research Organization (CRO) to prepare for and conduct PharmaCyte’s clinical trial in pancreatic cancer.
In its clinical trial, PharmaCyte’s pancreatic cancer treatment (microcapsules containing live cells that convert the cancer prodrug ifosfamide into its cancer-killing form together with low doses of ifosfamide) will be compared with the combination of the cancer drug capecitabine plus radiation therapy. The clinical trial will be an open-label, “two-armed,” randomized multi-site trial.
The morning session addressed how the clinical trial will be structured and conducted. It was determined that there will be several cancer centers in the United States, with a number of study sites in Europe and possibly Australia. Discussions also dealt with suggested changes related to the number of patients in each arm of the trial, inclusion/exclusion criteria for patients that will be enrolled in the trial and possible sites at which the trial will be conducted.
The afternoon session focused on the IND and the timeline for filing it with the FDA. The afternoon session also included discussions related to the content and preparation of the Chemistry, Manufacturing and Controls (CMC) section of the IND. The CMC section is a pivotal part of the IND and will be a major focus of the FDA when it examines PharmaCyte’s IND submission. TD2 and Chamow & Associates (Chamow) will both prepare the CMC section of the application. Chamow has already performed an inspection and audit of Austrianova’s live-cell encapsulation facility in Bangkok, Thailand. That is the facility where the genetically modified live cells will be encapsulated using the Cell-in-a-Box® technology that are part of PharmaCyte’s pancreatic cancer treatment.
In commenting on the sessions at TD2, Waggoner stated, “These face-to-face meetings with TD2’s clinical trial team were extremely important and exceedingly helpful to PharmaCyte in finalizing the design of the clinical trial. We believe they will prove to be invaluable as we move forward with the preparations for our upcoming clinical trial in pancreatic cancer. The interactions that we had with the team at TD2 in this one day alone reinforce our belief that, in TD2, we have the finest CRO available in which to put our trust that PharmaCyte’s clinical trial will be prepared and conducted as well as it could be.”
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
$PMCB Pharmacyte Biotech is Poised to Rock the Diabetes Treatment Boat
After a century of maintaining the status quo, Pharmacyte Biotech Inc. (OTCMKTS:PMCB) is working on a quantum leap in the treatment of diabetes.
While the last few decades have seen some amazing advances in medicine, one area that hasn't changed much - if at all - is diabetes treatments. The current standard of care is insulin injections, and though they've certainly improved since first being introduced back in the 1920's the basic premise is no different now than it was then. A small, up-and-coming biotech company called Pharmacyte Biotech Inc. (OTCMKTS:PMCB), may be about to change the diabetes treatment paradigm.
Diabetes, in simplest terms, is an excess of glucose (sugar) in the bloodstream. Normally the human body can process and remove this glucose with insulin produced naturally produced by the pancreas. For diabetics, however, the insulin-producing beta cells in the pancreas are destroyed by that body's immune system. Though type 2 diabetes can often be treated by weight loss and better dietary habits, type 1 diabetes - "the bad one" - cannot be self-regulated by diet and exercise.
Proposed solutions to the type 1 diabetes problem have been varied, and each has its merits.
The simplest solution (and the one still primarily used) was, as noted, is injecting insulin into the diabetic patient's bloodstream. This is the solution Novo Nordisk A/S (NYSE:NVO) introduced nearly a century ago. The downside? Even a small needle is still a needle, and the required dosage is forever changing with a diabetic's glucose levels.
MannKind Corporation (NASDAQ:MNKD) arguably introduced the biggest leap in the world of insulin treatments last year, winning the FDA's approval for AFREZZA... and inhaled form of insulin. While this approach circumvents the needle, questions remain over the long-term safety of delivering insulin through the lungs.
And in between those two milestones, several companies toyed with the idea of depositing or replacing the islet cells in the pancreas as a therapy for type 1 diabetes, which would effectively serve as a cure for the disease. These ideas showed promise too, but were largely problematic. Either these cells were still ultimately attacked by the immune system, or the mechanical structure required to place them in the pancreas failed.
To this day, the only viable treatment of type 1 diabetes is the original one... forcing insulin into the bloodstream from outside the body, one way or another. Pharmacyte Biotech may be about to change this with what could effectively be seen as a cure for the disease.
The technology is called Cell-in-a-Box. Pharmacyte Biotech developed it as a means of depositing living, normally-functioning cells into a particular part of the body where their presence would have a therapeutic effect. In this case, the cells "in the box" would be insulin-producing islet cells placed within the pancreas. Just like a patient's own cells would detect the presence of glucose and begin producing insulin, the cells inside the encapsulation are capable of sensing high levels of glucose and produce an appropriate amount of insulin.
It's an idea that's been tried before, but as was noted, it's an idea that's generally failed one way or another. The game-changer Pharmacyte brings to the table, however, is the Cell-in-a-Box encapsulation biotechnology.
The key to Cell-in-a-Box is the combination of the right polymers added to the mix in the right way at the right time.
The process starts out with a mix of live cells (insulin-producing pancreatic cells in this case) and a polymer which is then passed through a droplet-forming device into a bath of another proprietary polymer. When the two polymers meet, a membrane is formed, with the living cells inside of it. This membrane keeps the cells in, lets insulin out, lets nutrients in, and most important, prevents the body's immune system from destroying these cells.... something most previous encapsulation attempts couldn't do.
And that's the proverbial quantum leap for diabetics - an encapsulation technology that actually works for the long haul.
There's still work to be done. Cell-in-a-Box as a treatment pathway for type 1 diabetes is currently in the preclinical research phase, though it was recently validated as a safe biotechnology by University of Veterinary Medicine Vienna. Then again, its confirmed safety can't even be counted as a pleasant surprise, as it's the same delivery technology that's now part of a phase 2 study as a treatment means for pancreatic cancer.
Whatever the case, Pharmacyte Biotech is one step closer to beginning human clinical trials of the diabetes treatment approach. That alone could prove catalytic for its stock, as it has the potential to change the way the world thinks about treating diabetes.
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