London, ON (PRWEB) January 22, 2014
Imagine there is a person with diabetes who must focus on measuring their blood sugar levels almost constantly followed by injection of insulin multiple times each day or monitoring their insulin pump delivery to keep their diabetes under control. And yet, to make matters worse, they still have the potential to develop the serious long-term complications of diabetes, such as cardiovascular disease, blindness, and amputations. And, for the approximately 30% of people with Type 1 diabetes who have hypoglycemia unawareness, every insulin injection has the potential to severely drop their blood sugar levels to dangerous levels without being aware.
London, Ontario-based Sernova Corp. (TSXV: SVA), is developing a better way to treat the disease involving the replacement of lost pancreatic islets, whose function is to read blood sugar levels and release insulin into the blood, normalizing blood sugar levels. To bring this therapy to reality, the company has developed a small, thin credit card sized medical device, called the Cell Pouch System™, which is inserted under the skin into which new islets are placed, replacing the endocrine function of the pancreas. The islets connect to the blood stream and function normally, eliminating the need to take insulin either by injections or insulin pump. As well, with normal glucose control, the diabetes complications are expected to be significantly reduced.
The Cell Pouch System™, a scalable product, has the advantage of being made with well-known and safe FDA approved materials. When placed under the skin, it uniquely develops an organ-like environment rich in blood vessels for survival and long term function of the therapeutic cells.
Sernova’s innovation could also be used in the treatment of any disease where a protein or hormone is required such as Haemophilia A, a bleeding disorder caused by deficiency of clotting Factor VIII. The company’s prophylactic therapy would be used to reduce the Factor VIII infusion costs, currently estimated at over $200,000 per year for each patient for the thrice weekly treatments, while at the same time improving upon the patient’s quality of life. To that end, Sernova announced on September 10, 2013, that it has entered into a collaboration agreement with Medicyte GmbH to jointly evaluate the use of Medicyte's upcyte™ cells in Sernova's Cell Pouch™ for the treatment of haemophilia patients. If this work is successful, the companies will be looking to testing this product in human clinical trials.
For investors, this represents an opportunity to get in at the early stages of Sernova’s growth and attempt to capture a share of what has become a multi-billion dollar market. In North America alone, there are approximately nine million people with diabetes requiring insulin injections.
“Currently, insulin sales are about $14 billion a year and Factor VIII sales at $5 billion a year. Sernova’s disruptive technology has the potential to change how people with these diseases are treated – to significantly improve the quality of their lives which will benefit both patients and investors as our products become adopted once approved for sale,” says Sernova’s President and CEO, Dr. Philip Toleikis, Ph.D.
Sernova is currently conducting a Phase I/II human clinical trial led by Dr. James Shapiro at the University of Alberta, to test the safety and efficacy of its Cell Pouch System™ in patients with diabetes who are receiving an islets transplant. To give the company a leg up into clinical testing, those patients are taking the latest anti-rejection drugs along with the company’s Cell Pouch™, which is giving the company the proof of concept of its Cell Pouch System™ in patients receiving this type of transplant.
“Dr. Shapiro has released the first interim data from the clinical trial showing that the Cell Pouch™ is safe and the islets within the Cell Pouch™ are healthy, well-vascularized and are making insulin and all the regulatory hormones required to control the diabetes. This is a very positive first step and a glimpse into the results of the study early on.” Toleikis says.
Dr. Shapiro is currently enrolling more patients to assess efficacy or, in other words, how well it is working over the longer term. If the company can show that the Cell Pouches™ can control the sugar levels well, then it plans to expand the clinical trial to include more patients and additional countries. Sernova anticipates that by doing this it can move towards international approval of the product for islet transplantation.
Dr. Toleikis believes that for both its company’s internal diabetes program and haemophilia program under development with Medicyte GMBH, if the infusions into the Cell Pouch™ system using human donor cells show good efficacy, the company will work rapidly towards gaining marketing approval of these products. Sernova is also looking at alternative sources of cells, such as progenitor stem cells, which could provide enough cells to treat a virtually unlimited number of patients.
“The next big step beyond products with human donor cells would be to advance towards a progenitor stem cell technology that would be infused into the Cell Pouch™,” Toleikis added. Success in this area would allow Sernova to treat millions of patients and that is where the multi-billion dollar market lies.
If the efficacy of the Cell Pouch System™ is proven, then Sernova feels it would eventually be able to take a meaningful share of the insulin and insulin pump market, and companies operating in those markets would likely become very interested in Sernova’s technology from a licensing and co-development perspective.
Dr. Toleikis said Sernova is currently in contact with a number of large pharmaceutical companies as well as soliciting for potential development collaborations such as the one established with Medicyte GMBH for haemophilia. The company boasts 20 issued and pending patents around its technologies.
Sernova is well capitalized with at least a 24-month runway, which will enable the company to achieve a number of significant milestones. According to Dr. Toleikis, they have been approached more than a few times recently by investors interested in making investments but the company does not plan to raise additional equity at this time.
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