Oh, Canada; oh, diabetes
Sernova seeks FDA approval for U.S. clinical trial on Cell Pouch System for diabetics
LONDON & ONTARIO—Targeted toward changing the treatment method of people diagnosed with severe type 1 diabetes (T1D) who are hypoglycemia unaware, Canadian health sciences company Sernova Corp., plans to spend $2.5 million in funding from the Juvenile Diabetes Research Foundation (JDRF) to conduct its first clinical trial testing its innovative implantable device, the Cell Pouch System (CPS). Documentation supporting the study will be sent to the U.S. Food and Drug Administration (FDA) for approval before the end of the year, with plans to kick off the human trial at an undisclosed major U.S. university in the first quarter of 2017, Philip Toleikis, Sernova’s president and CEO, has disclosed.
If the study proves successful, Sernova’s Cell Pouch System could be a game-changer for millions suffering from T1D.
“Our pathway into clinical trials in the United States—with our cell pouch and therapeutic cell technologies—is advancing the hope for a significant improvement in the treatment of patients with insulin-dependent diabetes,” Toleikis told DDNews.
People with diabetes who have hypoglycemia unawareness are at a higher risk of acute life-threatening consequences that can lead to coma and death following an insulin injection that reduces blood glucose to dangerously low levels.
The internal CPS device “is implanted under the skin in patients where it creates an organ-like environment,” Toleikis says. “No electronics are involved. We are putting in natural cells.”
Sernova’s novel cell macroencapsulated implantable and scalable Cell Pouch System treats low blood sugar in people with severe T1D by releasing therapeutic cells, thus reducing or eliminating the need for injections of exogenous insulin, Toleikis says. The medical device forms highly vascularized chambers, ideal for therapeutic cells (donor, xenogeneic or stem cell-derived therapeutic cells) which then release proteins and/or hormones as required to treat the disease, he says.
The CPS system takes pricking the skin for blood sugar levels out of the picture. The device could be a lifesaver for diabetics who also have hypoglycemia unawareness and do not recognize insulin-induced drops in blood sugar levels which could reach acute dangerous levels, the company states.
If successful, the CPS protocol could offer an advantage over current treatments, which often rely on injections to deliver therapy, Toleikis says. Many patients can’t undergo injections because of potentially lethal complications.
“Sernova and JDRF are tightly aligned in our vision to see cell-based therapies developed to reduce disease burden and significantly increase the quality of life for people living with [Type 1 diabetes],” Toleikis said in a press release. “We see our work with JDRF on this important clinical trial as an exciting opportunity to more rapidly advance Sernova’s therapies to treat people with diabetes and address many of the shortcomings and challenges of current insulin therapy.”
Dave Prowten, president and CEO of JDRF Canada, says, “Sernova’s progression to human clinical trials is an incredible accomplishment in the global diabetes research agenda. I am particularly proud of this trial being a part of the JDRF portfolio because it supports advancements of the best and brightest research minds in Canada at Sernova. Working together with our global partners, we can accelerate this type of transformative research and ensure it becomes available for the T1D community.”
Currently, a procedure known as “islet cell transplantation” is used on some diabetics that involves transplanting islet cells from a donor’s pancreas into a diabetic patient’s liver through a blood vessel—or a “big injection” into the portal vein of the liver, the company states.
In this procedure, infused islets can result in toxicities such as liver hypertension resulting from blockage of small blood vessels where the islets lodge. In addition, a large proportion of infused islet cells die during or after the process, often requiring multiple treatments to achieve efficacy.
Because of these and other issues, as well as the low number of available islet donors in addition to diminishing efficacy over time, the procedure is available to only a small fraction of the most severely ill T1D patients, Toleikis says.
Sernova is ultimately trying “to develop a product consisting of our prevascularized, human scaled Cell Pouch which creates an ideal environment for locally immune-protected therapeutic cells from a virtually unlimited source to treat all patients with insulin-dependent diabetes,” he continues. Achieving unlimited cell sources would mean that many more people could benefit from this treatment, he notess, adding that if the Cell Pouch were to successfully act as a vessel for those cells and protect them from immune destruction, “the result would effectively, be a cure for type 1 diabetes and those who are insulin-dependent.”