BMELs and Osteoarthritis
There is increasing evidence that bone marrow edema lesions (BMLs) play an important role in the development of knee OA. In established OA, BMLs are associated with knee pain and progression (on x-ray or MRI) of knee OA and cartilage loss. The potential for PPS to improve outcomes for patients with OA and BMLs is supported by real world experience, with 30 patients treated through the Special Access Scheme over the past 12 months.
Paradigm is now conducting a phase 2b clinical trial (randomised, placebo-controlled) to investigate PPS in subjects with BMLs and OA. Please see the trial details on the ANZCTR website here.
Ross River Virus (RRV)
With reports of an increasing number of people infected in the recent outbreak of RRV in Victoria*, Paradigm is pursuing research to provide hope to those patients who suffer persistent and debilitating arthritis and joint pain following RRV infection. Having received ethics approval in May 2017, recruitment and screening for Phase II clinical trials in the treatment of RRV (Australia) has commenced. Details of the trial can be viewed here, on the Australian New Zealand Clinical Trials Registry.
Bone marrow edema (BME)
In 2016, we commenced an open label clinical trial to investigate the safety, tolerability and efficacy of ZILOSUL® in the treatment of patients with a ruptured Anterior Cruciate Ligament (ACL) injury. The trial is progressing well, with eleven patients treated, and close-out of the study expected in October 2017.
Allergic Rhinitis (AR)
In December 2016, Paradigm commenced a Phase II clinical trial in Lund, Sweden, evaluating one of the nasal spray PPS formulations under development. In January 2017 we announced successful recruitment of 40 subjects into the trial. Progress and results from the trial have been shared via our ASX announcements.
For additional details on the Phase I trial, completed in 2016, click here.