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Paradigm’s iPPS shown to reduce cartilage loss and improve function in osteoarthritis patients
Late-stage drug development company Paradigm Biopharmaceuticals (ASX: PAR) has announced positive study data from a Phase 2 clinical trial of injectable pentosan polysulfate sodium (iPPS) for the treatment of acute pain associated with knee osteoarthritis. The study investigated changes in synovial fluid biomarkers with iPPS treatment compared with placebo in 61 participants administered with twice-weekly […]
Paradigm Biopharma’s knee osteoarthritis trial meets secondary endpoints, launches capital raise
Paradigm Biopharmaceuticals (ASX: PAR) has announced trial patients being treated with its injectable pentosan polysulfate sodium (iPPS) drug for osteoarthritis of the knee have confirmed improved knee function and pain reduction for six months. The biotechnology company today confirmed its phase 2b clinical trial has successfully met its key secondary endpoints of improved knee function […]
Paradigm Biopharmaceuticals advances Zilosul osteoarthritis program, to trial drug in MPS patients
Paradigm Biopharmaceuticals (ASX: PAR) has completed treatment of its Zilosul injectable pentosan polysulfate (iPPS) drug under the US Food and Drug Administration’s expanded access program, while collaring FDA orphan status for using it in treating MPS-I. Also known as compassionate use, the expanded access program provides a pathway for doctors to use investigational drugs, biologics […]
Paradigm doses all trial patients with Zilosul while dodging COVID-19 impact
An experimental treatment for knee osteoarthritis developed by Paradigm Biopharmaceuticals (ASX: PAR), Zilosul, has now been dosed in all ten patients under the FDA approved expanded access – otherwise known as compassionate use – program in the US. In a statement to investors, Paradigm said patients being treated are at different stages of the treatment […]
Paradigm Biopharmaceuticals announces first Zilosul patient under FDA approved program
Paradigm Biopharmaceuticals (ASX: PAR) has declared that the first patient has been dosed under the FDA-approved expanded access program (EAP) for Zilosul in the US, with first results expected sometime in the third quarter of this year. The participants in the program will receive two Zilosul injections per week over a six-week period in line […]
Paradigm Biopharmaceuticals gears up for busy year of clinical trials and regulatory submissions in 2020
With progress to secure regulatory approvals underway for its flagship Zilosul treatment, Paradigm Biopharmaceuticals (ASX: PAR) is also gearing up for phase 2/3 clinical trial in the first quarter of next year. Paradigm is preparing for a joint advice application with the US Food and Drug Administration, and European Medicines Agency (EMA) in Europe to […]
Regulatory progress means Paradigm Biopharmaceuticals will treat ex-NFL players with Zilosul later this year
Paradigm Biopharmaceuticals (ASX: PAR) has been given the go-ahead by US regulators to treat 10 former NFL players with its pentosan polysulfate sodium (iPPS) drug, otherwise known as Zilosul. Following the successful US Food and Drug Administration approval of the Expanded Access Programme (EAP), Paradigm has announced that the Institutional Review Board (IRB) has also […]
Paradigm Biopharmaceuticals looks to alleviate opiate crisis following ‘ground-breaking discovery
Paradigm Biopharmaceuticals (ASX: PAR) claims it has made a “ground-breaking discovery” as part of its ongoing development of pentosan polysulfate sodium (PPS), an antithrombotic agent that reduces joint pain. The biotech company conducted research into PPS to prove that bone cells under the cartilage produce the pain mediator known as “NGF” and looked into whether […]
Paradigm Biopharma receives FDA clearance for investigational new osteoarthritis drug
Medical company Paradigm Biopharmaceuticals (ASX: PAR) has received clearance from the US Food and Drug Administration for an investigational new drug (IND) application relating to pentosan polysulfate sodium (PPS) for the treatment of knee osteoarthritis. The clearance was announced this morning within the 30-day review period and paves the way for the company to make […]
Paradigm Biopharma’s knee osteoarthritis trial shows injectable drug can slow cartilage degradation
Paradigm Biopharmaceuticals (ASX: PAR) has reported a breakthrough in its phase 2 clinical trial of the injectable pentosan polysulfate (iPPS) treatment drug Zilosul, showing it could act as a cartilage-protective agent and slow cartilage degradation in patients with progressive osteoarthritis of the knee. The trial has demonstrated a significant reduction in the levels of two […]
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