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- Drug developer Paradigm Biopharmaceuticals (PAR) has dosed its first U.S. patient with its knee osteoarthritis treatment
- The patient is one of 10 ex-NFL players to be treated with the product under the States’ “expanded access” program
- The somewhat-unusual patient sample represents a key market for the drug: ex-NFL players under 60 are three times more likely to develop osteoarthritis than the general U.S. population
- Former Carolina Panthers player Mitch Marrow — who is now employed by Paradigm — called the treatment “life-changing”
- Still, Paradigm shares have taken a slight hit today, down just under four per cent and worth $3.96 each
Drug developer Paradigm Biopharmaceuticals (PAR) has dosed its first U.S. patient with its Zilosul knee osteoarthritis treatment product.
The patient is the first of 10 ex-NFL players to be treated with the product. Under the program, the patients will be given two Zilosul injections every week or six weeks.
The patients will have their knees scanned and give baseline pain scores before their first injection, with follow-up scans and pain measurements to be recorded six weeks after the last.
The unusually-specific patient sample for this clinical trial provides a glimpse into what could be a key market for the drug. According to Paradigm, in males under 60 years old, osteoarthritis is three times more common in retired NFL players than the general U.S. population.
The treatment of the other nine patients will be staggered over the next four weeks, with test results expected in the July quarter this year.
What is Zilosul?
Paradigm’s product is known as an injectible pentosan polysulfate sodium, or iPPS, treatment.
PPS has conventionally been used to treat inflammation but has been fairly narrow in application. Up until Paradigm came along, the drug was primarily used for bladder inflammation and preventing deep vein thrombosis.
Paradigm is working to repurpose the drug to treat a range of conditions, with osteoarthritis among the contenders.
Expanded access for unmet needs
The Zilosul treatment will be rolled out in the States under the Food and Drug Administration’s (FDA’s) “expanded access” program.
Essentially, the program was designed to give doctors and patients access to experimental drugs for conditions that have no treatment or therapy outside of clinical trials.
The inclusion of Paradigm’s Zilosul product in this program shows that the FDA recognises the lack of effective osteoarthritis treatments in the U.S. and has allowed Paradigm to have a crack at filling that need. Through the program, only patients who have failed other conventional therapies can have access to Zilosul.
Paradigm CEO Paul Rennie said the first patient dosing is an important milestone for the company.
“The data collected from the 10 patients in the Extended [sic] Access Program will add strength to the data already collected from the 600+ patients Paradigm has treated throughout its successful Phase 2b clinical trials and SAS program in Australia,” Paul explained.
Anecdotal support, but too close to home?
Former Carolina Panthers player Mitch Marrow was previously treated with Zilosul in Australia under our own special access program. Mitch claims the treatment changed his life.
“The treatment was so life-changing in treating my years of pain and lack of mobility that I am thrilled more former NFL players will have access to this incredible drug in the U.S. under the expanded access program.”
Mitch Marrow, former NFL player, February 2020
However, Paradigm announced in December last year that the NFL-player-turned-businessman would be joining the company’s investor relations team — a role in which Mitch stepped into in January this year.
Though Mitch’s review is glowing, it may leave investors sceptical: did he join the company because he so strongly believed in the product, or is he touting the benefits of Zilosul because he’s paid to do so?
Regardless, Paradigm shares have taken a slight hit today. After a steady morning, shares dipped quickly at lunchtime AEDT and are currently 3.88 per cent down and trading for $3.96 each.
