Canadian firm Sernova wants to get rid of those pesky insulin injections, and all the costs and side effects associated with living with and managing a chronic disease like diabetes.
It is developing a treatment that makes use of an implanted device that will contain therapeutic islet cells capable of delivering insulin by sensing the levels of blood glucose. In effect the company aims to return the natural function of the human body by transplanting islet cells into a patient’s body that has lost the ability to produce insulin.
The polymer Cell Pouch in addition to containing islet cells, will also contain a local immune protection cell technology called Sertolin so that the patient’s body doesn’t reject the transplant.
The Cell Pouch is the size of a business card, explained Sernova CEO Philip Toleikis, in an interview outside the JP Morgan Healthcare Conference in San Francisco on Tuesday. Toleikis, who presented a day earlier at the conference, said that the Cell Pouch is implanted under the skin in the belly in a simple, 15-minute procedure.
Currently, the company is enrolling up to 20 patients in a safety and efficacy trial where the cell pouch and donated islet cells will work in conjunction with oral, anti-rejection medication.
But the goal in the future is to integrate the local immune protection technology into the Cell Pouch itself. Toleikis is also in talks with stem cell companies and makers of porcine cells to ultimately expand the supply of islet cells that the company can use to develop its therapy. At present, the islet cells come from organ donors. By increasing the supply of therapeutic cells, Toleikis ultimately hopes to be able to treat a larger number of patients.
Toleikis believes that Sernova’s product could represent a breakthrough in the world of diabetes. That’s because the billions of dollars incurred to manage the disease – from the cost of insulin injections to the cost of managing diabetes’ impact on the body in addition to other costs – will be dramatically reduced with the implanted device and cell therapy.
The first test of how successful the Cell Pouch/cell therapy combo works will come later this year when interim results of the safety and efficacy trial are available. Toleikis is hopeful that the positive results will help to raise a $15 million financing round. So far the company has raised $8 million through grants and investment.
“We have the funds to get us through the first quarter of 2014, if we didn’t raise another penny,” Toleikis said.
The 7-person firm, whose stock trades on the Toronto Venture Exchange, is currently looking to partner with device and/or pharma firms to further commercialization, which is still several years away.
“We are the first company in the world to be in clinical trials with a device is doing islet transplantation,” he said.
But Toleikis is confident. He has experience in multiple drug/device combination products, and conducted drug screening efforts to find optimal compounds for drug/device combination products while at Angiotech Pharmaceuticals where he was vice president R&D Pharmacology and Drug Screening. [That company grew from 10 employees in 1996 to more than 200 trading on both the Toronto and Nasdaq stock exchanges.]
“Drug and device combinations work. Now we need to show it in cell therapy and devices,” he said.