The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price was down as much as 5.1% today despite the announcement that it has treated its first patient with Zilosul in the United States.
A former NFL player is the first patient to receive injections of Zilosul in the US under the Federal Drug Administration's Expanded Access Program.
At the time of writing, Paradigm shares are trading 3.16% lower for the day at $3.99 per share.
Use of Zilosul
Paradigm is seeking to commercialise the use of Zilosul to treat knee osteoarthritis. Zilosul (iPPS) is not registered in Australia but was previously registered in Europe as an antithrombotic agent.
Paradigm has developed an injectable form of iPPS (Zilosul) which it believes can be used to treat osteoarthritis.
Use of Zilosul under Expanded Access Program
Under the Expanded Access Program, 10 ex-NFL players will receive two Zilosul injections per week over a six week period. This treatment is in line with the proposed treatment protocol for Paradigm's proposed Phase 3 pivotal study.
Each patient is first screened to measure their baseline pain scores and given MRI scans to determine the presence of Bone Marrow Edema Lesions within the knee joint. Follow up scans and pain measurements will be taken 6 weeks after the completion of treatment.
The remaining nine patients to be treated under the Expanded Access Program are staggered to commence over the next 4 weeks, with the last patients expected to receive their final dose in mid-May. Paradigm expects to report data on patient outcomes early in the third quarter of 2020.
What is the Expanded Access Program?
The Expanded Access Program provides a pathway for patients to gain access to investigational drugs intended to treat serious diseases or conditions for which there are no comparable or satisfactory options outside of clinical trials.
The FDA recognises that osteoarthritis can be a serious disease with an unmet need for therapies that can potentially change the course of the disease to prevent long-term disability.
In males under the age of 60, osteoarthritis is three times more common in retired NFL players than in the general population, possibly due to the high incidence of injury in football.
Mitch Marrow, a former NFL player who was treated with iPPS in Australia under a special access program, said, "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 US under the expanded access program."
