Sernova – Patentierte Zelltaschen mit Schutzschild gegen die Immunabwehr ! (Seite 834)
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Antwort auf Beitrag Nr.: 57.700.518 von techinvestor69 am 05.05.18 10:57:43http://www.sernova.com/press/?ID=218
"Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator; Leading Surgeon and Researcher in Islet Transplantation at the University of Chicago to act as Clinical Trial Principal Investigator. Study to focus on severely diabetic patients with hypoglycemia unawareness
Source: Sernova Corp.
May 8, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire May 8, 2018) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), announces Dr. Piotr Witkowski, M.D., Ph.D., a leading expert in type 1 diabetes (T1D) and islet transplantation, as the Clinical Trial Principal Investigator for Sernova’s new clinical study. Dr Witkowski, at the University of Chicago site, will work closely with Sernova’s team to conduct the clinical and regulatory aspects of the Cell Pouch trial.
Dr. Witkowski is a widely published diabetes researcher and respected surgeon with a longstanding record of success in both basic science and clinical research pertaining to islet cell and abdominal organ transplantation. Among other accomplishments, he was instrumental in developing an optimized islet isolation technique that greatly improved success in clinical transplants. Under Dr. Witkowski's leadership, multidisciplinary research teams at the University of Chicago are currently conducting several studies designed to improve the quality and outcomes of islet cell transplantation in patients with T1D.
“Sernova’s achievement to commence US human clinical trials is a key step to improving the therapeutic treatment for people living with diabetes. This Cell Pouch safety and efficacy trial aims to reduce the risk of hypoglycemia unawareness, a complication in which a patient is unable to recognize and control impending hypoglycemia resulting in a drop in blood sugar that can have life threatening consequences,” said Dr. Witkowski. “Our experienced diabetes treatment team at the University of Chicago sees the potential of this transformative therapy to benefit and substantially improve the care of T1D.”
“Improving the quality of life and outcomes of people with diabetes are Sernova’s main priorities, and we are grateful to have the opportunity to work with Dr. Witkowski and his expert team at the University of Chicago, a team known for outstanding diabetes research and patient care,” stated Dr. Philip Toleikis, Sernova’s President & CEO.
The study is a Phase I/II, non-randomized, unblinded, single-arm, company sponsored trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine, patients with hypoglycemia unawareness will be enrolled in the study under informed consent. Patients then will be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development in the Cell Pouch, an initial dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year, with interim patient results released at periodic intervals consistent with an open label study.
About Dr. Witkowski
Piotr Witkowski M.D. Ph.D. is an Associate Professor of Surgery and a transplant surgeon at the University of Chicago Medicine. He has been involved in islet transplantation research for the past 17 years, initially at Columbia University in New York City and then as a Director of the Pancreatic Islet Transplantation Program at the University of Chicago Medicine. For the last nine years, Dr. Witkowski has been conducting multiple clinical studies in intraportal islet allotransplantation in patients with brittle type diabetes as well as islet autotransplantation in patients with chronic pancreatitis. Recently, he accomplished a phase 3 clinical trial and is currently preparing application to the FDA for islet graft as a biological product, which is pivotal to enable islet transplantation to become available to patients as a standard of care procedure. Being aware of shortcomings of intrahepatic islet transplantation, Dr Witkowski has been working on optimization of the subcutaneous location for improved islet engraftment. He has proven the concept that this pre-vascularized site enhances islet survival in a preclinical diabetes model.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device (Cell Pouch) and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca "
"Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator; Leading Surgeon and Researcher in Islet Transplantation at the University of Chicago to act as Clinical Trial Principal Investigator. Study to focus on severely diabetic patients with hypoglycemia unawareness
Source: Sernova Corp.
May 8, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire May 8, 2018) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), announces Dr. Piotr Witkowski, M.D., Ph.D., a leading expert in type 1 diabetes (T1D) and islet transplantation, as the Clinical Trial Principal Investigator for Sernova’s new clinical study. Dr Witkowski, at the University of Chicago site, will work closely with Sernova’s team to conduct the clinical and regulatory aspects of the Cell Pouch trial.
Dr. Witkowski is a widely published diabetes researcher and respected surgeon with a longstanding record of success in both basic science and clinical research pertaining to islet cell and abdominal organ transplantation. Among other accomplishments, he was instrumental in developing an optimized islet isolation technique that greatly improved success in clinical transplants. Under Dr. Witkowski's leadership, multidisciplinary research teams at the University of Chicago are currently conducting several studies designed to improve the quality and outcomes of islet cell transplantation in patients with T1D.
“Sernova’s achievement to commence US human clinical trials is a key step to improving the therapeutic treatment for people living with diabetes. This Cell Pouch safety and efficacy trial aims to reduce the risk of hypoglycemia unawareness, a complication in which a patient is unable to recognize and control impending hypoglycemia resulting in a drop in blood sugar that can have life threatening consequences,” said Dr. Witkowski. “Our experienced diabetes treatment team at the University of Chicago sees the potential of this transformative therapy to benefit and substantially improve the care of T1D.”
“Improving the quality of life and outcomes of people with diabetes are Sernova’s main priorities, and we are grateful to have the opportunity to work with Dr. Witkowski and his expert team at the University of Chicago, a team known for outstanding diabetes research and patient care,” stated Dr. Philip Toleikis, Sernova’s President & CEO.
The study is a Phase I/II, non-randomized, unblinded, single-arm, company sponsored trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine, patients with hypoglycemia unawareness will be enrolled in the study under informed consent. Patients then will be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development in the Cell Pouch, an initial dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year, with interim patient results released at periodic intervals consistent with an open label study.
About Dr. Witkowski
Piotr Witkowski M.D. Ph.D. is an Associate Professor of Surgery and a transplant surgeon at the University of Chicago Medicine. He has been involved in islet transplantation research for the past 17 years, initially at Columbia University in New York City and then as a Director of the Pancreatic Islet Transplantation Program at the University of Chicago Medicine. For the last nine years, Dr. Witkowski has been conducting multiple clinical studies in intraportal islet allotransplantation in patients with brittle type diabetes as well as islet autotransplantation in patients with chronic pancreatitis. Recently, he accomplished a phase 3 clinical trial and is currently preparing application to the FDA for islet graft as a biological product, which is pivotal to enable islet transplantation to become available to patients as a standard of care procedure. Being aware of shortcomings of intrahepatic islet transplantation, Dr Witkowski has been working on optimization of the subcutaneous location for improved islet engraftment. He has proven the concept that this pre-vascularized site enhances islet survival in a preclinical diabetes model.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device (Cell Pouch) and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca "
Rechnen Sie mal damit dass sich Dinge auch hinziehen können
(Menschen Die Die Sernova "Geschichte" kennen wissen Das),
aber im Prinzip würde ich Diese Einschätzung nicht totaaaaal in Die Tonne hauen.
(Menschen Die Die Sernova "Geschichte" kennen wissen Das),
aber im Prinzip würde ich Diese Einschätzung nicht totaaaaal in Die Tonne hauen.
500 Millionen Dollar Börsenwert ist meine Vorstellung auf Sicht von 2-3 Jahren, wenn alles gut läuft
54 Millionen Dollar aktuell
54 Millionen Dollar aktuell
Techinvestor
(für "Ihren Jahrgang scheinen Sie auch ganz schön sportlich anzulegen", Das aber nur mal ein Randeindruck)
Was denken Sie denn Wo es mit Sernova "vielleicht hingehen könnte"?
Ich habe da Eine; recht Verfestigte sogar; Vorstellung.
Also ich habe Einen ordentlichen Rucksack voll von Diesem Laden.
LOOOOOOOOOONG.
So, Jetzt muss ich Mich aber wieder um Meine Spezial Flying Firma kümmern.
important things happened.
(für "Ihren Jahrgang scheinen Sie auch ganz schön sportlich anzulegen", Das aber nur mal ein Randeindruck)
Was denken Sie denn Wo es mit Sernova "vielleicht hingehen könnte"?
Ich habe da Eine; recht Verfestigte sogar; Vorstellung.
Also ich habe Einen ordentlichen Rucksack voll von Diesem Laden.
LOOOOOOOOOONG.
So, Jetzt muss ich Mich aber wieder um Meine Spezial Flying Firma kümmern.
important things happened.
40 Million Diabetics Could Benefit from Sernova’s Cell Pouch Technologies
Health-care costs have spiraled out of control in most countries, especially the U.S., where people can’t seem to lead healthy lifestyles. The latest data (from 2016) shows that the adult obesity rates exceeded 35% in five states (led by WV at 37.7%), 30% in 25 states, and 25% in 46 states. Estimates are that obesity costs the U.S. more than $150 billion in health-care each year. Part of this is due to one in 11, or about 30 million Americans, having diabetes, a chronic condition that is often helped by weight loss.
Diabetes is characterized by high levels of blood sugar (also called "blood glucose"). Insulin is a hormone produced in the pancreas by the islets of Langerhans that regulate the amount of glucose in the blood. For people with diabetes, insulin is either not produced (Type 1 diabetes), not enough is produced, or the body doesn’t use it right (Type 2 diabetes).
People with Type 1 diabetes are insulin-dependent, meaning they must use a device (albeit a syringe or some type of automatic device) to inject insulin into their body to survive. Type 2 diabetic subjects can be either insulin-free or insulin-dependent, based upon their stage of disease.
Type 2 is the most common type of diabetes, accounting for about 95% of all cases. It is estimated that there are more than 40 million people with diabetes – both Type 1 and Type 2 – worldwide.
At the leading edge of new devices and therapeutic cells for treatment of diabetes is a small powerhouse, London, Ontario-based Sernova Corp. (TSX-Venture:SVA) (OTCQB:SEOVF), the creator of the revolutionary Cell Pouch System™.
The Cell Pouch is a novel implantable and scaleable medical device that forms a favorable environment within its chambers for the housing and long-term survival and function of therapeutic cells. The cells could be integral to any number of functions, including releasing necessary proteins or hormones missing from the body to treat chronic diseases, such as diabetes, as an alternative to daily administration of drugs.
About the size of a business card and manufactured from medical-grade, U.S. Food and Drug Administration-approved materials, the Cell Pouch is biocompatible and safe, as demonstrated in multiple pre-clinical studies and ISO10993 biocompatibility studies.
Studies have shown the device to be easily implanted under the skin and incorporate with vascularized tissue, eliminating the risks of fibrosis that accompanies other implantable devices. Sernova is also developing new technology for immune protection, which will lower any chance of anti-rejection drugs being needed.
In three different animal models of diabetes, the Cell Pouch was transplanted with insulin-producing islets and demonstrated efficacy by the animals achieving sustained glucose control. That was followed by a small clinical trial in Canada that proved safety and biocompatibility of the Cell Pouch™ with islets necessary for glucose production.
Now, the goal is to get this into larger-scale clinical trials as quickly as possible to see if the Cell Pouch can deliver the same results in people with diabetes as it did in the lab models.
To that end, the Juvenile Diabetes Research Foundation is contributing funding for an upcoming Phase 1/2 clinical trial in the U.S. The FDA has recently allowed Sernova’s Investigational New Drug (IND) application for a study evaluating the Cell Pouch System for the treatment of Type 1 diabetes in people with hypoglycemia unawareness.
In the study, patients will be implanted with the Cell Pouch and associated islets and followed for six months, at which time a decision will be made as to whether a second islet dose will be administered. Patients will then be followed for another year, with the primary endpoint being safety and secondary endpoint being signals of efficacy.
To keep an eye on glucose levels at all times, the trial is incorporating the continuous glucose monitoring system of Medtronic (NYSE:MDT), a marriage of diabetes devices that investors would surely like to see explored more in the future if the Cell Pouch performs as hoped.
While an addressable market of over 40 million certainly is appetizing, the beauty of the Cell Pouch is its diverseness, where it can be adapted to many different indications and areas of unmet medical need, including Hemophilia A, a disorder that Sernova scientists are already working on.
Quelle: http://www.baystreet.ca/articles/stockstowatch/38546/40-Mill…
Health-care costs have spiraled out of control in most countries, especially the U.S., where people can’t seem to lead healthy lifestyles. The latest data (from 2016) shows that the adult obesity rates exceeded 35% in five states (led by WV at 37.7%), 30% in 25 states, and 25% in 46 states. Estimates are that obesity costs the U.S. more than $150 billion in health-care each year. Part of this is due to one in 11, or about 30 million Americans, having diabetes, a chronic condition that is often helped by weight loss.
Diabetes is characterized by high levels of blood sugar (also called "blood glucose"). Insulin is a hormone produced in the pancreas by the islets of Langerhans that regulate the amount of glucose in the blood. For people with diabetes, insulin is either not produced (Type 1 diabetes), not enough is produced, or the body doesn’t use it right (Type 2 diabetes).
People with Type 1 diabetes are insulin-dependent, meaning they must use a device (albeit a syringe or some type of automatic device) to inject insulin into their body to survive. Type 2 diabetic subjects can be either insulin-free or insulin-dependent, based upon their stage of disease.
Type 2 is the most common type of diabetes, accounting for about 95% of all cases. It is estimated that there are more than 40 million people with diabetes – both Type 1 and Type 2 – worldwide.
At the leading edge of new devices and therapeutic cells for treatment of diabetes is a small powerhouse, London, Ontario-based Sernova Corp. (TSX-Venture:SVA) (OTCQB:SEOVF), the creator of the revolutionary Cell Pouch System™.
The Cell Pouch is a novel implantable and scaleable medical device that forms a favorable environment within its chambers for the housing and long-term survival and function of therapeutic cells. The cells could be integral to any number of functions, including releasing necessary proteins or hormones missing from the body to treat chronic diseases, such as diabetes, as an alternative to daily administration of drugs.
About the size of a business card and manufactured from medical-grade, U.S. Food and Drug Administration-approved materials, the Cell Pouch is biocompatible and safe, as demonstrated in multiple pre-clinical studies and ISO10993 biocompatibility studies.
Studies have shown the device to be easily implanted under the skin and incorporate with vascularized tissue, eliminating the risks of fibrosis that accompanies other implantable devices. Sernova is also developing new technology for immune protection, which will lower any chance of anti-rejection drugs being needed.
In three different animal models of diabetes, the Cell Pouch was transplanted with insulin-producing islets and demonstrated efficacy by the animals achieving sustained glucose control. That was followed by a small clinical trial in Canada that proved safety and biocompatibility of the Cell Pouch™ with islets necessary for glucose production.
Now, the goal is to get this into larger-scale clinical trials as quickly as possible to see if the Cell Pouch can deliver the same results in people with diabetes as it did in the lab models.
To that end, the Juvenile Diabetes Research Foundation is contributing funding for an upcoming Phase 1/2 clinical trial in the U.S. The FDA has recently allowed Sernova’s Investigational New Drug (IND) application for a study evaluating the Cell Pouch System for the treatment of Type 1 diabetes in people with hypoglycemia unawareness.
In the study, patients will be implanted with the Cell Pouch and associated islets and followed for six months, at which time a decision will be made as to whether a second islet dose will be administered. Patients will then be followed for another year, with the primary endpoint being safety and secondary endpoint being signals of efficacy.
To keep an eye on glucose levels at all times, the trial is incorporating the continuous glucose monitoring system of Medtronic (NYSE:MDT), a marriage of diabetes devices that investors would surely like to see explored more in the future if the Cell Pouch performs as hoped.
While an addressable market of over 40 million certainly is appetizing, the beauty of the Cell Pouch is its diverseness, where it can be adapted to many different indications and areas of unmet medical need, including Hemophilia A, a disorder that Sernova scientists are already working on.
Quelle: http://www.baystreet.ca/articles/stockstowatch/38546/40-Mill…
Trading Spotlight
bei stockhouse gefunden - kam aber noch keine offizielle Pressemitteilung des Unternehmens
A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation
The Sernova Cell Pouch™ will be implanted under the skin. A minimum of three weeks after Cell Pouch™ implantation, immunosuppression will be initiated and optimized for another 3 weeks. This will allow for proper vascularization of the Cell Pouch™ chambers and the patient to be stabilized on immunosuppression prior to transplantation. A mass, >3,000 islet equivalent (IEQ) numbers per kg of patient body weight (IEQ/kg), of highly purified islets will be transplanted in the Cell Pouch™. The Cell Pouch™ will be assessed for safety and tolerability for up to one year following transplant. Data for the primary and secondary endpoints will be summarized using descriptive statistics (such as counts and percentages).
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020
https://clinicaltrials.gov/ct2/show/NCT03513939?term=diabete…
A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation
The Sernova Cell Pouch™ will be implanted under the skin. A minimum of three weeks after Cell Pouch™ implantation, immunosuppression will be initiated and optimized for another 3 weeks. This will allow for proper vascularization of the Cell Pouch™ chambers and the patient to be stabilized on immunosuppression prior to transplantation. A mass, >3,000 islet equivalent (IEQ) numbers per kg of patient body weight (IEQ/kg), of highly purified islets will be transplanted in the Cell Pouch™. The Cell Pouch™ will be assessed for safety and tolerability for up to one year following transplant. Data for the primary and secondary endpoints will be summarized using descriptive statistics (such as counts and percentages).
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020
https://clinicaltrials.gov/ct2/show/NCT03513939?term=diabete…
Sernova Announces Results of 2018 Annual General Meeting of Shareholders and New Chief Financial Officer
LONDON, Ontario, May 04, 2018 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE:PSH), announced shareholder approval of all management resolutions brought forward at the 2018 Annual General Meeting held in Vancouver, April 25th. In addition, we are pleased to announce Mr. Sean Hodgins, CA, CPA, CPA (Illinois) has joined Sernova as Chief Financial Officer, effective immediately. Mr. Hodgins will work in conjunction with Sernova’s CEO in the execution of the company’s financial, business development and capital markets strategies as well as future planned tracking to a US exchange.
“Mr. Hodgins is an experienced biotech executive with both US and Canada corporate background. He is joining Sernova at an important juncture as we embark on our US clinical study and further develop our international business relationships,” said Dr. Philip Toleikis, President and CEO, Sernova Corp.
A veteran of the biotechnology industry for over 20 years, Mr. Hodgins is a CA-CPA having earned a Bachelor of Commerce degree (economics) from the University of British Columbia. He has gained US and Canada experience having tenured at Deloitte LLP in Vancouver and Pricewaterhousecoopers LLP in San Jose, California. While in the US he managed two NASDAQ IPO’s, and on returning to Canada, several Canadian IPOs as well as serving as CFO for three TSX listed public companies and supporting a number of successful Canadian biotech companies.
Sernova thanks Mr. Scott Langille for his contribution as previous CFO and wishes him well in his future endeavours.
Management resolutions at the AGM which were approved by an overwhelming majority of shareholders who voted including election of the directors, Frank Holler (chair), James Parsons, Bruce Weber, Jeffrey Bacha and Dr. Philip Toleikis; approval of the stock option plan and amendments and approval of Davidson and Co. LLP as Sernova’s auditor for 2019.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device (Cell Pouch) and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
Source: Sernova Corp
LONDON, Ontario, May 04, 2018 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE:PSH), announced shareholder approval of all management resolutions brought forward at the 2018 Annual General Meeting held in Vancouver, April 25th. In addition, we are pleased to announce Mr. Sean Hodgins, CA, CPA, CPA (Illinois) has joined Sernova as Chief Financial Officer, effective immediately. Mr. Hodgins will work in conjunction with Sernova’s CEO in the execution of the company’s financial, business development and capital markets strategies as well as future planned tracking to a US exchange.
“Mr. Hodgins is an experienced biotech executive with both US and Canada corporate background. He is joining Sernova at an important juncture as we embark on our US clinical study and further develop our international business relationships,” said Dr. Philip Toleikis, President and CEO, Sernova Corp.
A veteran of the biotechnology industry for over 20 years, Mr. Hodgins is a CA-CPA having earned a Bachelor of Commerce degree (economics) from the University of British Columbia. He has gained US and Canada experience having tenured at Deloitte LLP in Vancouver and Pricewaterhousecoopers LLP in San Jose, California. While in the US he managed two NASDAQ IPO’s, and on returning to Canada, several Canadian IPOs as well as serving as CFO for three TSX listed public companies and supporting a number of successful Canadian biotech companies.
Sernova thanks Mr. Scott Langille for his contribution as previous CFO and wishes him well in his future endeavours.
Management resolutions at the AGM which were approved by an overwhelming majority of shareholders who voted including election of the directors, Frank Holler (chair), James Parsons, Bruce Weber, Jeffrey Bacha and Dr. Philip Toleikis; approval of the stock option plan and amendments and approval of Davidson and Co. LLP as Sernova’s auditor for 2019.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device (Cell Pouch) and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
Source: Sernova Corp
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