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$ZMRK Zalemark Projects Second Quarter Revenue to Exceed over 649.8%
Source: Access Wire
Zalemark Holding Company, Inc. Projects that 2nd Quarter Revenue to Increase Over 1865% Over Last Year
LOS ANGELES, CA / ACCESSWIRE / July 8, 2015 / Zalemark Holding Company, Inc. (OTC: ZMRK) is currently on track to exceed last year's revenue by over 1865%. Zalemark's, CFO Caren Currier states, "In my current calculations, we are already at a 649.8% increase in revenue Q2 over last year's Q2. It is an exciting time for the Zalemark team, as everyone has worked so hard and put in a lot of sweat equity to move Zalemark to the level of success its shareholders deserve."
Zalemark's CEO Steven Zale states, "The current direction is nothing short of the cohesive dedicated team work by all those who see the vision and the dream. We are now realizing the dream, as it comes to fruition."
About Zalemark Holding Company, Inc.- Zalemark Holding Company, Inc. is a publicly traded OTC company under the symbol, ZMRK. Zalemark is an award winning product design, development, manufacturing and distribution Company. Zalemark also operates stevenzale.com, Luxury Brands Group, Demeter(R) Brand, Divas Choice(TM) Brand, Dog Boxer Brand(TM), and Compralux Hispanic Shopping Network(TM), "The Harmony Collection" by Engelbert Humperdinck, Crayola(R) Fine Jewelry. These brands are widely known for their, "Mark of Quality" the company's tag line and the standard incorporated in all aspects of their business.
The information contained herein includes forward-looking statements. These statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Ernest Martel, EVP
818-582-2477
Info@zalemark.com
SOURCE: Zalemark Holding Company, Inc.
$ZMRK Zalemark Projects Second Quarter Revenue to Exceed over 649.8%
Source: Access Wire
Zalemark Holding Company, Inc. Projects that 2nd Quarter Revenue to Increase Over 1865% Over Last Year
LOS ANGELES, CA / ACCESSWIRE / July 8, 2015 / Zalemark Holding Company, Inc. (OTC: ZMRK) is currently on track to exceed last year's revenue by over 1865%. Zalemark's, CFO Caren Currier states, "In my current calculations, we are already at a 649.8% increase in revenue Q2 over last year's Q2. It is an exciting time for the Zalemark team, as everyone has worked so hard and put in a lot of sweat equity to move Zalemark to the level of success its shareholders deserve."
Zalemark's CEO Steven Zale states, "The current direction is nothing short of the cohesive dedicated team work by all those who see the vision and the dream. We are now realizing the dream, as it comes to fruition."
About Zalemark Holding Company, Inc.- Zalemark Holding Company, Inc. is a publicly traded OTC company under the symbol, ZMRK. Zalemark is an award winning product design, development, manufacturing and distribution Company. Zalemark also operates stevenzale.com, Luxury Brands Group, Demeter(R) Brand, Divas Choice(TM) Brand, Dog Boxer Brand(TM), and Compralux Hispanic Shopping Network(TM), "The Harmony Collection" by Engelbert Humperdinck, Crayola(R) Fine Jewelry. These brands are widely known for their, "Mark of Quality" the company's tag line and the standard incorporated in all aspects of their business.
The information contained herein includes forward-looking statements. These statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Ernest Martel, EVP
818-582-2477
Info@zalemark.com
SOURCE: Zalemark Holding Company, Inc.
$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.
$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.
$PMCB PharmaCyte’s Novel Diabetes Treatment Approach Could Prove Superior to Other Methods Under Development
Forecasts for the number of people that will be diagnosed with diabetes in the coming years are staggering. While many treatments exist to treat some of the effects of diabetes on patients afflicted with the disease, a “holy grail” to truly treat the disease has yet to be developed. Clearly, an out of the box approach is required. If future test results affirm the data derived from recent studies, the PharmaCyte Biotech (OTCQB – PMCB - $0.07 – Spec Buy) Cell-in-a-Box® diabetes treatment platform could emerge as the treatment of choice for this disease.
Dozens of studies and trials to treat Type 1 and Type 2 diabetes are ongoing, given that the size of the global diabetes market for therapeutic devices and drugs is expected to reach US $114.3 billion by 2018, according to a report by Transparency Market Research. However, since results have been mixed for even the largest and most successful companies, industry participants are now exploring new ideas and new approaches that have demonstrated efficacy in early studies, which could serve as an indirect or direct benefit to PharmaCyte.
For example, one of the top two players in diabetes treatment, Novo Nordisk (NYSE – NVO), announced that it is collaborating with IBM (NYSE – IBM) to combine IBM’s cognitive computing capabilities with diabetes research by collecting and analyzing real-time data from patients using Novo Nordisk treatments and devices. The hope is that this venture leads to improved solutions for diabetes management. Novo Nordisk also submitted a new type of fast-acting mealtime insulin to the FDA for approval, a departure from its primary offerings. Meanwhile, Novo Nordisk competitor Eli Lilly (NYSE – LLY), which has had six diabetes treatments approved since 2014 halted development of a promising diabetes treatment under development. If a company with 6 approved drugs in a treatment category is still working on the problem, and another leader is moving outside of its comfort zone in an effort to develop the most effective therapy available, it is an indication that the time is now for PharmaCyte.
The Company has the exclusive worldwide rights to use Melligen cells to treat diabetes. Melligen cells are genetically engineered from human liver cells and have been shown to secrete insulin in response to the concentrations of glucose (blood sugar) in their environment. A recent article published in scientific journal Molecular Therapy noted that when Melligen cells were transplanted into diabetic mice whose immune systems were essentially not functioning, the blood glucose levels of the mice became normal.
This observation illustrates that Melligen cells can reverse the diabetic condition. PharmaCyte plans to encapsulate a human cell line that has been genetically modified to produce, store and release insulin in response to blood glucose levels in their surroundings. Therefore, the Melligen cell line, when combined with Cell-in-a-Box® encapsulation, could ultimately become a treatment that has clear advantages over current therapies used for Type 1 diabetes and Type 2 insulin-dependent diabetes and could potentially replace them. As a result, we look for these shares to move toward the $0.20 level in early 2016.
$PMCB PharmaCyte’s Novel Diabetes Treatment Approach Could Prove Superior to Other Methods Under Development
Forecasts for the number of people that will be diagnosed with diabetes in the coming years are staggering. While many treatments exist to treat some of the effects of diabetes on patients afflicted with the disease, a “holy grail” to truly treat the disease has yet to be developed. Clearly, an out of the box approach is required. If future test results affirm the data derived from recent studies, the PharmaCyte Biotech (OTCQB – PMCB - $0.07 – Spec Buy) Cell-in-a-Box® diabetes treatment platform could emerge as the treatment of choice for this disease.
Dozens of studies and trials to treat Type 1 and Type 2 diabetes are ongoing, given that the size of the global diabetes market for therapeutic devices and drugs is expected to reach US $114.3 billion by 2018, according to a report by Transparency Market Research. However, since results have been mixed for even the largest and most successful companies, industry participants are now exploring new ideas and new approaches that have demonstrated efficacy in early studies, which could serve as an indirect or direct benefit to PharmaCyte.
For example, one of the top two players in diabetes treatment, Novo Nordisk (NYSE – NVO), announced that it is collaborating with IBM (NYSE – IBM) to combine IBM’s cognitive computing capabilities with diabetes research by collecting and analyzing real-time data from patients using Novo Nordisk treatments and devices. The hope is that this venture leads to improved solutions for diabetes management. Novo Nordisk also submitted a new type of fast-acting mealtime insulin to the FDA for approval, a departure from its primary offerings. Meanwhile, Novo Nordisk competitor Eli Lilly (NYSE – LLY), which has had six diabetes treatments approved since 2014 halted development of a promising diabetes treatment under development. If a company with 6 approved drugs in a treatment category is still working on the problem, and another leader is moving outside of its comfort zone in an effort to develop the most effective therapy available, it is an indication that the time is now for PharmaCyte.
The Company has the exclusive worldwide rights to use Melligen cells to treat diabetes. Melligen cells are genetically engineered from human liver cells and have been shown to secrete insulin in response to the concentrations of glucose (blood sugar) in their environment. A recent article published in scientific journal Molecular Therapy noted that when Melligen cells were transplanted into diabetic mice whose immune systems were essentially not functioning, the blood glucose levels of the mice became normal.
This observation illustrates that Melligen cells can reverse the diabetic condition. PharmaCyte plans to encapsulate a human cell line that has been genetically modified to produce, store and release insulin in response to blood glucose levels in their surroundings. Therefore, the Melligen cell line, when combined with Cell-in-a-Box® encapsulation, could ultimately become a treatment that has clear advantages over current therapies used for Type 1 diabetes and Type 2 insulin-dependent diabetes and could potentially replace them. As a result, we look for these shares to move toward the $0.20 level in early 2016.
$PMCB This Short Video Explains Why Novo Nordisk and Sanofi Should Fear Pharmacyte Biotech
$PMCB This Short Video Explains Why Novo Nordisk and Sanofi Should Fear Pharmacyte Biotech
$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
$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
$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
$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
$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
$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
$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/