The EAP provides a pathway for doctors and patients to gain access to investigational drugs such as Zilosul® to treat serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.
Paradigm will treat 10 patients comprised of ex-NFL players under the EAP.
The patients will receive two injections per week over six weeks, with the 10 patients to have staggered starts over the next 4 weeks.
Dosing in-line with forthcoming Phase 3 Pivotal Study
Paradigm’s CEO Paul Rennie said: “This is an important milestone for Paradigm as we continue to progress toward the commencement of the Phase 3 Pivotal Study and commercialisation of Zilosul® as a potential first line treatment for Knee Osteoarthritis.
“The data collected from the 10 patients in the Extended 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.
“We are looking forward to releasing more information in due course about the progress of the Pivotal Phase 3 Study and are hopeful that a positive experience under this EAP will help drive public interest in the forthcoming trials the company expects to conduct in 2020.”
EAP similar to Australia’s SAS and collects real-world data
Mitch Marrow, a former NFL Player with the Carolina Panthers was the first to be treated with iPPS, in Australia under the special access program (SAS).
Marrow 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”.