Melbourne-based Paradigm Biopharmaceuticals Limited (ASX:PAR) has been granted approval by the Human Research Ethics Committee (HREC) to proceed with the open-label pilot clinical trial to determine the safety and tolerability of ZILOSUL in patients with a BME lesion.
This study in 40 patients will administer ZILOSUL twice weekly for a period of three weeks in patients exhibiting a BME lesion identified by MRI in association with bone pain and reduced joint function following an Anterior Cruciate Ligament (ACL) injury.
Paradigm’s CEO, Mr Paul Rennie; said “the HREC approval enables commencement of the Company’s clinical development program of ZILOSUL in the orthopaedic indication.”
Mr Rennie highlighted that unresolved traumatic BME lesions may be the harbinger of post-traumatic osteoarthritis and he emphasised there is currently no registered pharmaceutical agent approved to treat this unmet medical need.
ZILOSUL involves repurposing Pentosan Polysulphate (PPS) to treat BME lesions. PPS is a drug with long history of use and safety in humans, said the company.
The Pilot study will be carried out in two Medical Centres in Australia – Southern Orthopaedics in Adelaide, South Australia (Principal Investigator, Professor Jegan Krishnan) and Box Hill in Melbourne, Victoria (Principal Investigator, Dr Ruben Branson).
Expected duration is 12 months subject to patient recruitment.
Dr Branson, who is the Principal Investigator at Sportsmed Biologic Medical Centre, Box Hill in Melbourne, said: “People, especially athletes, who have anterior cruciate ligament injuries are more likely to develop osteoarthritis compared to people who haven’t had an ACL injury”.
Dr Branson added, “We are excited to see if the ZILOSUL, when used shortly after the anterior cruciate ligament injury, can preserve the knee cartilage and therefore delay or even prevent the onset of osteoarthritis in the injured knee. We are looking forward to reviewing the results of this initial pilot study in about 12 months’ time”.