Several doctors from Australian Football League (AFL) clubs are taking advantage of Paradigm Biopharma’s (ASX: PAR) existing drug for the treatment for knee, hip and groin pain which has not responded to current therapies.
The drug is made available under the Therapeutics Goods Administration’s (TGA) Special Access Scheme (SAS).
According to Paradigm’s CEO Paul Rennie, seven AFL clubs have taken advantage of the new treatment, currently being used by 40-50 former and current AFL players with reportedly outstanding results.
One of the clubs confirmed to be using the treatment is Carlton Football Club, with at least three more Melbourne-based teams also cited as being participants.
Given the associated public interest, especially from footy fans that idolise the players playing for their teams, the AFL clubs involved in the use of the medication have been coy to provide exact details regarding which players have been treated by Paradigm’s patented drug candidate Pentosan Polysulfate Sodium (PPS).
Pain reductive potential
As reported last month, Paradigm’s PPS drug reduced joint pain and improved knee function in 84.4% of patients as part of the company’s TGA-approved special access scheme, with this week’s revelations that around 40-50 of its patients are former or current AFL players.
In addition to the TGA SAS, Paradigm is also conducting a randomised double-blind placebo-controlled phase 2b clinical trial currently recruiting patients and expects to “read-out” in Q4 CY2018 with results from the SAS likely to be considered usable as “real-world-evidence” to supplement the phase 2 trial.
Paradigm says that there are currently 180 people being treated under the TGA’s special access scheme and that results available so far show that pain scores on 45 patients were reduced on average by 50%.
Furthermore, an earlier study published in 2010 concluded that “Pentosan treatment in twenty patients with mild knee OA seemed to provide improvements in clinical assessments.”
If proven to be efficacious in the phase 2 clinical trial, injectable PPS could be on the market within the next two years.
The treatment of sporting injuries and degenerative osteoarthritis are multi-billion-dollar markets.
Looking deeper into Pentosan Polysulfate Sodium
According to Paradigm, PPS is a “semi-synthetic drug manufactured from European beech xylans that are sulphated to produce a negatively charged product that mimics glycosaminoglycans (GAGs)”.
The company says these complex carbohydrates have a regulatory role in the body through interacting with proteins involved in inflammation.
The drug has been previously used to treat blood clots and painful bladder syndrome in oral capsule form. But after being repurposed and provided via subcutaneous injections of around 1.5 millilitres, Paradigm says the drug’s capabilities are proving to be more applicable in treating high-performance athletes with osteoarthritis, caused by the breakdown of cartilage in joints.
In its current phase 2 trial, patients are administered with two injections of PPS per week for six weeks for a total of 12 injections.
The experimental treatment for joint pain could potentially transform how sport-related injuries are treated, and in turn, improve recovery times for existing athletes.
Speaking to Small Caps, Paul Rennie said that retired Carlton Blues player Andrew Walker, whose AFL career was crippled by knee osteoarthritis, was one of the first players to be treated with the medication.
Prior to being administered with PPS, “he could hardly walk between practise sessions” and “didn’t respond to any other available therapy”, says Mr Rennie.
However, after using PPS, Andrew Walker was reported to be free from all joint pain, “running between 20-30 kilometres per week and playing football again,” at country level.
Mr Rennie said that AFL club doctors were given the go-ahead to consider the use of PPS in patients under the TGA SAS. Under the TGA SAS doctors need to have considered all available therapies before applying to use the medication.
The medication is not on any list of banned substances in sport and this was confirmed by AFL Chief Medical Officer Dr Peter Harcourt.
Mr Rennie also confirmed that six current AFL players suffering from ‘osteitis pubis’ (pelvis inflammation) were treated with PPS in the recent off-season.
“There’s no doubt it works and the AFL doctors who have used it love it,” said Mr Rennie.
With several AFL clubs confirmed to be using PPS, and with such great success being reported by patients, it may only be a matter of time until Paradigm’s PPS drug is being used by other AFL clubs and other high-performance sports in Australia and overseas.
Paradigm shares were up 7% and trading around $0.30 per share in light trade.