A Canadian clinical trial will begin at the end of May on the Prosorba® Column, the only new non-drug treatment for rheumatoid arthritis approved by Health Canada. Medexus Inc. and the Canadian Arthritis Network (CAN) recently reached an agreement to conduct further clinical studies of the device which removes harmful antibodies and immune complexes from the blood of patients with rheumatoid arthritis. Medexus Inc. has the exclusive license to distribute the Prosorba® Column in Canada. For company founders, Bruce Clark and Ken d’Entremont, the clinical testing is just one of the many steps that the pair have taken since leaving successful careers to form a new business.
Both Clark and d’Entremont had significant careers within the pharmaceutical industry, but recognized that there were medical and technology areas that could be served by a niche healthcare provider. Their niche was to find medical technologies to help people live a better quality of life. The Prosorba® Column is a significant advancement in the treatment of rheumatoid arthritis. The scientific entrepreneurs understood the importance of the Column’s therapeutic technology, especially to women suffering from rheumatoid arthritis.
At present, there are more than 250,000 Canadians who suffer from rheumatoid arthritis, two-thirds of whom are women. It is a chronic, inflammatory condition brought on by the body’s immune system attacking cartilage, bone and occasionally organs. Patients undergo a series of drug treatments to combat the symptoms, but some patients have adverse reactions to the long-term effects of these treatments. As well, the drugs cannot be taken if a patient is pregnant. Cypress Bioscience Inc., the developer of the Prosorba® Column granted an exclusive license to Medexus Inc. Getting the licensing agreement was only the first step. Clark and d’Entremont then had to seek Health Canada approval to use the Prosorba Column. Health Canada granted approval in February and the agreement with CAN was signed at the end of March. The clinical trials are essential to the successful use of the device in Canada. Dr. Edward Keystone, CAN’s associate clinical director and director of the centre for advanced therapeutics in arthritis at Mt. Sinai Hospital in Toronto, emphasizes that clinical trials are a rigorous method of evaluating the effectiveness and safety of new treatments for diseases. “This trial will be particularly important for people who have found that conventional medical therapy for rheumatoid arthritis has not helped them, or for patients who do not want to use those medications as part of their treatments.” The treatment involves passing some of the patient’s blood through the coffee cup sized Prosorba® column. A protein inside the column binds tightly to the antibodies present in the patient’s plasma.
These antibodies “stick” to the protein and stay in the column. The patient then receives the treated blood. Patients undergo one treatment per week for 12 weeks and generally do not have to take any further treatments for about a year. Clark and d’Entremont have also launched another product, a device that helps men with urinary incontinence. The two men are confident that as the demand for new therapies and treatments grows, Medexus Inc. will grow as well. “Helping people with chronic conditions and improving the quality of life is more than just good business,” says d’Entremont. “It’s also a way of giving something back to society.”
Sources: Canadian Arthritis Network, EurekAlert