Paradigm Biopharmaceuticals secures FDA approval for their investigational new drug application. The emerging biopharmaceutical company submitted an Expanded Access IND for pentosan polysulfate sodium (PPS) for the treatment of about 10 ex-NFL patients with pain associated with knee osteoarthritis (OA) with concurrent bone marrow lesions where patients are failing to the prevailing standard of care. The principal investigator for compassionate use studies will be ex-Green Bay Packer Dr. John Michels of Interventional Spine and Pain LLP of Dallas, Texas.
FDA’s Expanded Access
Expanded access, also known as “compassionate use,” is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Pentosan Polysulfate Sodium (PPS)
The Expanded Access approved study is based on the use of pentosan polysulfate sodium or PPS. This is a semi-synthetic drug manufactured from European beech xylans that are sulphated to produce a negatively charged product that mimics glycosaminoglycans (GAGs). These complex carbohydrates have a regulatory role in the body through interacting with proteins involved with inflammation. PPS also has a mild antithrombotic activity. Paradigm Biopharma is actively repurposing PPS for new indications, including arthritis.
TrialSite News reviewed website ClinicalTrials.gov for other PPS clinical trials. A total of six (6) are reported—3 completed, 1 terminated, 1 “unknown” and 1 recruiting. None involved Paradigm Bio nor PPS. Back in 2003, there was a survey of the use of PPS for osteoarthritis, which revealed mixed results have been reported.
NFL Players at Risk – Adverse Effects
NFL players (American football) are at risk for a number of life-long ailments including osteoarthritis—in fact, for males under 60, arthritis is 3 times more prevalent in this patient group than the general U.S. population.
Clinical Investigator is Ex-Football Player
Dr. John Michels is with Interventional Spine and Pain, LLP. They were founded with the belief that the most effective method of improving chronic pain conditions is through a multidisciplinary approach and non-surgical interventional procedures. This is accomplished with an understanding of the fact that pain can impact an individual’s quality of life functionality, emotionally, and socially. Generally, the Dallas, Texas-based practice focuses on conservative and interventional procedures with the goal of minimizing dependence on opioids to improve quality of life, function and pain coping skills to help the patient better adapt to their daily activities and get back to their normal daily function.
Paradigm Biopharma CEO Comments
Paradigm CEO Paul Rennie reports “This clearance demonstrates the need for effective and safe therapies for the serious chronic disease of osteoarthritis. It also provides validation of the Paradigm dossier, which contained information about our non-clinical and toxicology, our manufacturing and our clinical data and data about the previous human experience with the drug.” FDA’s clearance means validation of Paradigm’s 1) safety data 2) the finished product’s quality, and 3) confirmation of an unmet medical need. Rennie continues, “Dr. Michels will be treating people with osteoarthritis who have failed to respond to standard of care medications. Paradigm now looks forward to the completion of Expanded Access Program and reporting on those results in the months ahead.”
An Australian-based microcap stock, Paradigm currently trades at $1.85 with a market capitalization of $270.5 million. Essentially, they’re a pre-revenue R&D company losing on average about $7.02 million, based on Yahoo Finance reports. With about $9 million cash in the bank, they executed an IPO in 2015. The company focuses on the creation of commercial opportunities to generate potential revenue from early sales of finished product or through partnering/commercial transactions. According to a Proactive Investors story by John Miller, the company was on track back in June of this year for IND for both OA and an orphan indication of MPS. The first returns for the company, post Phase III clinical trials would be from OA (osteoarthritis) and MPS (Mucopolysaccharidosis) and Ross River virus (RRV).
Miller reports back in the Summer that Paradigm’s Ross River trial data triggered partner discussions with the U.S. Department of Defense and other possible partners for additional development. Moreover, the company has invested to design, build, and complete a Good Manufacturing Practice (Gm) for iPPS to be used in forthcoming Phase III trials, including the PPS clinical trial of ex-football players in America.
Dr. John Michels of Interventional Spine and Pain, LLP
Call to Action: Are you an ex-athlete with severe osteoarthritis? You may want to track this study to determine how the intervention (PPS) may help. Seek an introduction—TrialSite Network concierge services will connect you.