Paradigm Biopharmaceuticals (ASX:PAR) is sponsoring an open label clinical trial at Southern Orthopaedics in Adelaide, South Australia.
Paradigm is a Melbourne-based biopharmaceutical company focused on repurposing the drug ‘pentosan polysulphate sodium’ (PPS), under the brand name ZILOSUL, for the treatment of bone marrow edema (BME).
The clinical trial is seeking to investigate if ZILOSUL can resolve BME lesions (bone bruising) arising from sporting or accidental injuries to the knee such as a ruptured Anterior Cruciate Ligament (ACL).
The Principal Investigator at the Southern Orthopaedics clinic, Professor Jegan Krishnan, announced the clinical trial has commenced and he and his colleagues are now actively recruiting participants.
Unresolved bone marrow edema or bone bruising is considered to be a potent risk factor for osteoarthritis following injury. The use of ZILOSUL shortly after the injury may resolve the bone bruise and potentially improve the long-term health of the knee cartilage.
The trial at Southern Orthopaedics clinic in Adelaide is the second site that Paradigm has initiated following the initiation of Box Hill’s Sportsmed Biologic medical clinic. Both centres are now actively involved in recruiting subjects in this 40 participant open-label pilot clinical trial to determine the safety and tolerability of ZILOSUL in participants with a BME lesion.
ZILOSUL will be administered twice weekly for a period of three weeks in participants exhibiting a BME lesion identified by MRI in association with bone pain and reduced joint function following an ACL injury.
“Some patients are waiting for surgery for six to twelve months and during this time inflammatory changes in the injured joint are building up and setting the scene for a long term disease process as a result of the BME lesions that may lead to post-traumatic osteoarthritis,” said Professor Krishnan.
“Therefore I am very interested to assess in this pilot open label trial the effectiveness of ZILOSUL as an early interventional agent that will target the BME lesions which occur as a result of the ACL rupture in these participants as identified by MRI,” added Professor Krishnan.
Paradigm’s CEO, Mr Paul Rennie, said that in addition to the primary end point of safety and tolerability to ZILOSUL therapy, outcomes of pain, function, BME lesions and disease biomarkers are being investigated.
“This open-label study design will allow us to “road test” the efficacy parameters of ZILOSUL before undertaking a randomised double-blind placebo-controlled Phase 2b clinical trial,” said Mr Rennie.
“Paradigm’s team of scientists, nurses and other specialists assisted in preparing the clinical trial site at Southern Orthopaedics clinic to enable the launching of the clinical trial”. Professor Krishnan said clinical trial subjects are being recruited from people across the community, including subjects involved in sporting activity who have played at both the elite and amateur levels," he added.