Paradigm Biopharmaceuticals Ltd (ASX:PAR) has entered a research partnership with NFL Alumni Health (NFLAH) that will inform NFL Alumni Association (NFLAA) members about osteoarthritis (OA) disease onset and progression, current treatment options and provide information about actively enrolling clinical trials throughout the US.
The NFLAA has more than 10,000 members and represents former NFL players, coaches, executives, spouses, cheerleaders and associate members through its 40 chapters across the US.
PAR was introduced to NFL Alumni Health by expanded access program (EAP) participants, who strongly advocate the company’s Zilosul® treatment for knee osteoarthritis (KOA).
The relationship between PAR and NFL Alumni Health demonstrates the company’s leading role in developing a multi-modal nonaddictive treatment for the pain and dysfunction associated with KOA.
Paradigm has so far treated 10 former NFL players suffering from KOA via an FDA-cleared EAP with pentosan polysulfate sodium (Zilosul®). At the 12-week time point (six weeks following final injection), participants experienced an average 65% reduction in pain as assessed with the WOMAC® index.
NFL Alumni Association co-director of Healthcare Initiatives Kyle Richardson said of the partnership: “The NFL Alumni Health division of the NFL Alumni Association is driven to provide initiatives that help its members learn more about and gain access to safe and effective treatments through clinical trials and other FDA approved treatment options.
"In males under the age of 60, arthritis is over three times more prevalent in retired NFL players than in the general US population.
"We are pleased to hear the positive experience several of our alumni members have had through working with Paradigm and we hope this partnership will inform a larger number of alumni on the disease of osteoarthritis and the available clinical trials that are currently enrolling participants.”
Looking after the NFL community
NFL Alumni Health is a wholly-owned subsidiary of NFLAA and appraises corporate partners that may provide beneficial research opportunities in health areas relevant to their members.
The organisation oversees the vetting process to ensure they bring credible and meaningful health sector-related partnerships to their membership.
Paradigm’s designation as NFLAH’s newest corporate and research partner demonstrates its leading role in developing a safe and effective potential treatment for those suffering with OA.
Expanded access program
Paradigm had previously submitted an IND application for an expanded access program protocol to treat 10 patients for osteoarthritis-associated knee pain with Zilosul®. The US FDA provided clearance to proceed in September 2019.
The company released the results of this EAP in July 2020, demonstrating that at week 12, the 10 participants treated with Zilosul® achieved an average WOMAC® pain reduction of 65%.
Zilosul® was well tolerated in this program.
Paradigm remained in close contact with the EAP physician and participants, leading to an introduction to NFL Alumni Health. The NFL endorsed this partnership following a review of Paradigm’s clinical program results as well as the ongoing global registration clinical trial.
Paradigm CEO Marco Polizzi said of the milestone: “Having followed the progress of the expanded access program participants and hearing first-hand the positive impact Zilosul® has had on their lives, Paradigm is honoured to be able to continue to work with NFL Alumni members to inform them of the onset and progression of osteoarthritis and Paradigm’s clinical progress through phase 3 as we strive to bring Zilosul® to commercialisation for the millions suffering from the debilitating effects of OA.”