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 al 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. Many shouldn’t take or can’t tolerate current oral analgesics because of side effects. The need for effective and safe analgesics for osteoarthritis is well known, and this study further reinforces the credibility of FLEXISEQ as a treatment to fill that need with a targeted, effective, drug free and safe gel.”
Professor Conaghan, who will be a key speaker at the Irish Society of Rheumatology event in Trim (Co. Meath) later this month added “I am delighted to hear that FLEXISEQ has launched in Ireland and is helping so many patients.”
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 was well tolerated with only 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.
Ascension Healthcare plc is a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for the treatment of haemophilia and osteoarthritis. The Company has three products in clinical development for the treatment of haemophilia A and also a range of internationally marketed products for osteoarthritis sufferers. For more information please visit: www.ascension.co.uk/
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