555 patient clinical trial provides further evidence that FLEXISEQ is effective in reducing pain for osteoarthritis patients with a particularly strong safety profile.
London, England 6 September 2013 –Key clinical trial data supporting Pro Bono Bio’s (“PBB”) drug-free osteoarthritis treatment FLEXISEQ, have been published in The Journal of Rheumatology. This is the latest high profile publication after winning the German Pharmacy Industry award for innovation in January 2013.
The publication reports that FLEXISEQ (TDT 064) was very effective in managing the pain associated with osteoarthritis (OA) and was again found to have a much stronger safety profile than other treatments.
Dr Matthias Rother, lead author of the publication, said: ‘This is an important study which further confirms the safety and efficacy of FLEXISEQ for treatment of the chronic pain and stiffness that troubles so many patients with OA. The effect size seen here for FLEXISEQ is comparable to the effect sizes seen in a comparative study using the same design which demonstrated that FLEXISEQ has equivalent efficacy to the widely used oral NSAID, celecoxib. That study was published in “Rheumatology” earlier this year (Conaghan et 2013). These two studies are among several which consistently demonstrate the benefits of this drug-free gel.’
The findings offer hope to osteoarthritis patients, particularly those who are at risk from the common gastrointestinal and cardiovascular side effects associated with NSAIDs, such as celecoxib and diclofenac (which has been the subject of further health warnings from the EMA in July).
Professor Conaghan, co-author of the paper, said: “Osteoarthritis is a widespread and chronic disease that causes pain and loss of function which adversely affects patients’ lives. A great many patients suffer from OA and this number is growing. Many of these patients shouldn’t take or can’t tolerate current oral analgesics because of side effects. There is a desperate need for new effective and safe analgesics for osteoarthritis and this study provides further insight into the efficacy of this treatment that has demonstrated excellent safety and tolerability.”
Professor Conaghan, who will be a key speaker at the Irish Society of Rheumatology event in Trim (Co. Meath) later this month, added “The launch of FLEXISEQ™ in Ireland provides an opportunity for patients to have access to a new approach for managing their OA symptoms and we look forward to knowing more about this treatment”.
Deborah Osborne, Commercial Director of McCabe’s pharmacy in Ireland, said: ”The demand is unbelievable. It’s an innovative product that’s drug free - and that’s the huge attraction…the problem is just keeping it in stock - it's flying.”
The latest publication reports on a study conducted in 39 clinical sites in the US. At the end of the 12 week trial period, the 281 patients who applied FLEXISEQ twice a day experienced a 44.6% mean reduction in pain on the widely accepted WOMAC scale with pain relief reported at the earliest time point assessed Similar reductions were reported for joint function (42.3%) and stiffness (43.8%). As would be expected for a drug-free, non-systemic treatment, FLEXISEQ has an excellent safety profile, particularly when compared to NSAIDs, with the majority of product related adverse events being mild to moderate local skin irritations that disappeared with continued use.
Awarded ‘Innovation of 2013’ in Germany by the Federal Association of German Pharmacists, FLEXISEQ is engineered to treat osteoarthritis via a physical mode of action. The product employs Sequessome Technology® rather than an active pharmaceutical ingredient to address an underlying cause of the symptoms of osteoarthritis, relieving pain with comparable efficacy to celecoxib, as shown in the Rheumatology publication.
Martyn Smith, of Pro Bono Bio said: “This is an important reinforcement of the efficacy and safety profile of Flexiseq. We have seen great interest from the medical community and huge demand from patients, many of whom have regarded it as a “Wonder Gel”.
FLEXISEQ is already available in Germany, Austria, Ireland and Malaysia (from pharmacies and clinics). PBB intends to make the product available to new markets later this year, bringing this important innovation to more patients.
About Sequessome Technology
Sequessome Technology utilises nanostructures called Sequessome vesicles that cross the skin barrier after the gel's topical application and migrate through various tissues to reach the target joint. Once inside the joint, Sequessome vesicles accumulate on the damaged cartilage forming a lubricating layer. This targeted, physical mode of action crucially means there are no drug-to-drug interactions with FLEXISEQ as it is not itself a drug and, as a result, it can be used by patients who may be taking a variety of medications for other diseases, without increasing their drug burden. FLEXISEQ is also a welcome option for patients considered ‘at risk’ from the common side effects associated with NSAIDs for example, those with such conditions as high blood pressure and/or gastric disorders.
