Sernova – Patentierte Zelltaschen mit Schutzschild gegen die Immunabwehr ! (Seite 811)
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Keine ahnung. Ein vorbote? Ich hab jedenfalls ganz teuer wieder gekauft. Morgen und montag komm ich nicht mehr dran. Usa 33%
Weiß jemand warum in Kanada der Kurs explodiert?
Antwort auf Beitrag Nr.: 60.340.978 von Popeye82 am 12.04.19 13:31:44
Top, alles läuft in die richtige Richtung. Ich sammele fleißig ein, bei diesem Niveau kann man nichts falsch machen mMn
Zitat von Popeye82: Meinung(en)??
Ich muss noch Stockhouse "nacharbeiten".
Top, alles läuft in die richtige Richtung. Ich sammele fleißig ein, bei diesem Niveau kann man nichts falsch machen mMn
Antwort auf Beitrag Nr.: 60.340.978 von Popeye82 am 12.04.19 13:31:44"The company is expecting to report preliminary safety data from Sernova's clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019."
Das wird entscheidend. Wenn diese Daten positiv ausfallen, sollte die Aktie eine Neubewertung erfahren. Bis dahin indes wird es weiter ein Geduldsspiel. Daher bei mir weiter "nur" Watchlist.
M@trix
Das wird entscheidend. Wenn diese Daten positiv ausfallen, sollte die Aktie eine Neubewertung erfahren. Bis dahin indes wird es weiter ein Geduldsspiel. Daher bei mir weiter "nur" Watchlist.
M@trix
Antwort auf Beitrag Nr.: 60.340.036 von techinvestor69 am 12.04.19 11:30:27Meinung(en)??
Ich muss noch Stockhouse "nacharbeiten".
Ich muss noch Stockhouse "nacharbeiten".
Trading Spotlight
Sernova completes first Cell Pouch transplant in trial
2019-04-11 10:56 ET - News Release
Dr. Philip Toleikis reports
SERNOVA ANNOUNCES FIRST TRANSPLANTATION OF THERAPEUTIC CELLS IN CELL POUCH FOR THE COMPANY'S PHASE I/II U.S. CLINICAL STUDY FOR DIABETES
Sernova Corp. has completed the first Cell Pouch transplant of insulin-producing cells in its U.S. phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for clinical islet transplantation in Type 1 diabetes.
"Sernova's Cell Pouch technologies are positioned to provide the most severe patients with improved, long-term options to manage their diabetes," said Dr. Piotr Witkowski, clinical trial principal investigator and director of the pancreatic islet transplant program at the University of Chicago. "The current standard of care, involves islet transplants into the portal vein, which has significant limitations, including the development of an immediate blood-mediated inflammatory reaction (IBRM), limited supply of donor organs, and the challenges in isolating and obtaining a consistent quality of islet preparations."
In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This procedure enables the development of vascularized tissue chambers and provides an interval for patient stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In accordance with the protocol, the Sentinel Pouch will be removed approximately 90 days after transplant to assess islet survival as an interim indicator of efficacy.
"Sernova's Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic cells to enhance the curative potential of islet transplantation and other cell therapies," said Dr. Philip Toleikis, president and chief executive officer of Sernova. "We are thrilled with Dr. Witkowski's progress as well as his decision to move forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch."
"This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for cell therapies across a range of indications, including Type 1 diabetes, hemophilia and thyroid disease," added Dr. Toleikis.
The company is expecting to report preliminary safety data from Sernova's clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.
About the study
The approved protocol is a phase I/II non-randomized, unblinded, single-arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.
A Sentinel Pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second islet dose with subsequent safety and efficacy follow-up. Patients will then be further followed for one year. The primary objective of the study is to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.
About hypoglycemia unawareness and diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for Type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day, along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high-blood-sugar or low-blood-sugar episodes are daily threats, and only a third of people with Type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for health complications related to Type 1 diabetes. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15 per cent of Type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease. The device, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small-animal and large-animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.
...
Quelle: www.stockwatch.com
2019-04-11 10:56 ET - News Release
Dr. Philip Toleikis reports
SERNOVA ANNOUNCES FIRST TRANSPLANTATION OF THERAPEUTIC CELLS IN CELL POUCH FOR THE COMPANY'S PHASE I/II U.S. CLINICAL STUDY FOR DIABETES
Sernova Corp. has completed the first Cell Pouch transplant of insulin-producing cells in its U.S. phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for clinical islet transplantation in Type 1 diabetes.
"Sernova's Cell Pouch technologies are positioned to provide the most severe patients with improved, long-term options to manage their diabetes," said Dr. Piotr Witkowski, clinical trial principal investigator and director of the pancreatic islet transplant program at the University of Chicago. "The current standard of care, involves islet transplants into the portal vein, which has significant limitations, including the development of an immediate blood-mediated inflammatory reaction (IBRM), limited supply of donor organs, and the challenges in isolating and obtaining a consistent quality of islet preparations."
In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This procedure enables the development of vascularized tissue chambers and provides an interval for patient stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In accordance with the protocol, the Sentinel Pouch will be removed approximately 90 days after transplant to assess islet survival as an interim indicator of efficacy.
"Sernova's Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic cells to enhance the curative potential of islet transplantation and other cell therapies," said Dr. Philip Toleikis, president and chief executive officer of Sernova. "We are thrilled with Dr. Witkowski's progress as well as his decision to move forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch."
"This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for cell therapies across a range of indications, including Type 1 diabetes, hemophilia and thyroid disease," added Dr. Toleikis.
The company is expecting to report preliminary safety data from Sernova's clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.
About the study
The approved protocol is a phase I/II non-randomized, unblinded, single-arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.
A Sentinel Pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second islet dose with subsequent safety and efficacy follow-up. Patients will then be further followed for one year. The primary objective of the study is to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.
About hypoglycemia unawareness and diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for Type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day, along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high-blood-sugar or low-blood-sugar episodes are daily threats, and only a third of people with Type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for health complications related to Type 1 diabetes. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15 per cent of Type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease. The device, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small-animal and large-animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.
...
Quelle: www.stockwatch.com
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