Sernova's Cell Pouch trial shows insulin independence
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Posted by Garry on 10:51:34 2010/07/12
Sernova's Cell Pouch trial shows insulin independence
2010-07-12 07:37 ET - News Release
Dr. Philip Toleikis reports
SERNOVA ANNOUNCES POSITIVE RESULTS OF ITS PROPRIETARY CELL POUCH
SYSTEM(TM) IN PRECLINICAL DIABETES MODEL
Sernova Corp. has released positive results from a long-term study evaluating the
safety and efficacy of the Cell Pouch System in a preclinical model of diabetes.
Detailed data will be presented at the 23rd international conference of the
Transplant Society, Vancouver, Aug. 15 to 19, in a presentation entitled, "A novel
Cell Pouch?, an alternative to intrahepatic islet transplantation."
Dr. Philip Toleikis, Sernova's president and chief executive officer, noted: "Our Cell
Pouch System is a proprietary medical device implanted under the skin rapidly
forming into a tissue-engineered, organ-like structure that provides a natural
environment for the survival and function of therapeutic cells. These long-term
results represent a significant achievement as a possible alternative to the current
practice of injecting islets directly into the portal vein of the liver.
"Our data are profound because they suggest the potential to reduce side effects
associated with the current standard of care and achieve glucose control with
significantly fewer islets than normally required," said Dr. Toleikis.
As reported in Stockwatch news on March 16, 2010, Sernova reported initial results
demonstrating that the Cell Pouch System becomes rapidly vascularized and
achieved initial glucose control in subject animals.
The following summarizes important new findings reported today:
Long-term insulin independence was successfully achieved with significantly fewer
islets than the current standard of care, requiring only about 10 per cent of
insulin-producing islets normally used for the Edmonton Protocol.
Animals in the study achieved long-term glucose normalization throughout the
course of the study.
Standard laboratory tests demonstrated transplanted islets produced insulin and
responded similarly to non-diabetic animals to provide control of glucose.
No adverse events related to the Cell Pouch System occurred during the study.
About the study
The Cell Pouch System was implanted in pigs which were then made diabetic
through removing the pancreas and chemical induction. The animal's own islets
(autograft) isolated from the pancreas were transplanted into the device. Standard
measures of efficacy including fasting and non-fasting glucose levels, glucose
tolerance tests (IVGTT), and C-peptide were taken up to 72 days posttransplant. At
the end of the study period, the device containing the islets was removed and the
animals returned to a diabetic state.
Following transplantation, a substantial number of study animals maintained
glucose levels within the normal range, showed glucose tolerance tests (IVGTT)
similar to non-diabetic animals and were C-peptide positive, an important
confirmation of insulin-producing islet function. Microscopic fluorescence analysis
of the device revealed both microvessels and insulin associated with islets.
Upon removal of the Cell Pouch System-containing islets, fasting glucose levels
returned to the diabetic range and animals required daily insulin injections to
maintain normal glucose levels. The animals return to the diabetic state was
further confirmed by IVGTT and C-peptide analysis.
From a safety perspective, no adverse events occurred related to the Cell Pouch
throughout the study following implantation of over 40 devices for up to five
months. The devices were well incorporated with collagen at all time points and yet
were not visible under the skin, an important consideration for patients.
Dr. David White, chairman of Sernova's scientific advisory board, stated: "I am
particularly enthusiastic about these results and the potential clinical relevance to
patients suffering from diabetes. These new data suggest that the Cell Pouch
System represent a possible clinically relevant alternative to injection of islets into
the portal vein of the liver and may reduce the side effects of transplantation
including the instant blood-mediated reaction (IBMR). The indication that our
device achieves glucose control with a reduction in the number of islets normally
required is also of profound clinical importance as it may increase the availability
of life-changing islet transplantation to many diabetic patients."
Sernova believes that the Cell Pouch System has the potential for a wide range of
uses in cell therapy, including the treatment of diabetes, hemophilia and other
chronic debilitating diseases. Based on these encouraging results, the company is
taking steps toward clinical evaluation of its Cell Pouch System.
According to the American Diabetes Association approximately nine million
Americans require insulin injections and it is the sixth leading cause of death in
the United States. One out of every $8 spent on health care in the United States is
spent on treating diabetes and its complications. Worldwide expenditures on
insulin alone are estimated to be $15-billion annually and growing.
We seek Safe Harbor.
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