Paradigm Biopharmaceuticals is a drug repurposing company … Professional athletes may soon have a new treatment for knee osteoarthritis after Paradigm Biopharmaceuticals (ASX: PAR) received glowing endorsements from two former NFL players undergoing the current round of Zilosul® treatment trials. Paradigm’s new licensing deal for MPS can be commercialised quickly for an orphan indication with revenue potential per year of over US$1 … Paradigm Biopharmaceuticals Ltd will be heavily focused on its Phase 3 trial of its osteoarthritis treatment Zilosul® in 2021, its chief operating officer Jeannie Joughin told Proactive.. Paradigm announced promising results from trials into the use of Zilosul. Paradigm is well-positioned to successfully commercialise Zilosul® (injectible PPS) as a first-class blockbuster drug. The submission includes reports on the phase 1 study in healthy volunteers completed in quarter … The participants in the program will receive two Zilosul injections per week over a six-week period in line with the proposed … For general enquiries, please contact us at: info@paradigmbiopharma.com. PPS is a strong therapeutic candidate for osteoarthritis patients given that it: has been shown to block the effect of cartilage degrading enzymes, has anti-inflammatory effects, targeting multiple cytokines … 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. PARADIGM BIOPHARMACEUTICALS LIMITED ASX RELEASE 18th February 2020 Paradigm reports: first patient dosed in USA under FDA approved Expanded Access Program KEY HIGHLIGHTS • First Participant dosed with Zilosul® (iPPS) in the US under the FDA approved Expanded Access Program (EAP). Paradigm has repurposed injectable PPS (iPPS) into their own drug called Zilosul®, to treat Bone Marrow Edema Lesions (BMEL) associated with OA, Viral Arthritis (Ross River virus) and Heart Disease. The arthritis treatment company will be testing its Zilosul drug in the trials to evaluate the reduction of pain in patients with osteoarthritis. With Paradigms' Zilosul® not even on the radar yet, it seems only a matter of time before the company’s valuation start to reflect the commercial opportunity next to their nearest comparable. The trials of Zilosul® have been conducted on ten patients suffering from varying degrees of knee osteoarthritis under the Food … In a statement to investors, Paradigm said patients being treated are at different stages of the … Paradigm Biopharmaceuticals Ltd has completed dosing of all ten patients with Zilosul® under the FDA’s IND EAP in the US. Paradigm works closely with the manufacturer, bene pharmaChem, in sourcing the material for formulation as ZILOSUL® and RHINOSUL®. The data is consistent with that previously reported from 76 earlier patients to receive Zilosul under the Australian Therapeutic Goods Administration (TGA) Special Access Scheme. 10 Patients are being treated for knee osteoarthritis using the trademarked injectable pentosan polysulphate sodium drug Zilosul®. Paradigm Biopharmaceuticals Ltd (ASX: PAR) now has an agreed upon regulatory path forward for the development of Zilosul, for the treatment of knee osteoarthritis (OA), after receiving positive feedback from an EMA scientific advice meeting. The Biotechnology Innovation Organization is the world's largest biotech trade association. Paradigm Biopharmaceuticals (PAR) has enrolled its first patient in its knee osteoarthritis (OA) biomarker study in Box Hill, Victoria. Level 6, 121 King … Zilosul® (Paradigm’s drug) appears to be the best in class for treating OA and will become a blockbuster. The participant in the PARA_OA_008 study was selected at random and has begun study procedures, including join aspiration to collect baseline biomarker synovial fluid information. News. Learn about BIO, register for events and explore member services. Highlights Download the first full, in-depth report on Paradigm Biopharmaceuticals Ltd here. Zilosul is not registered for use in Australia, and we are concentrating our efforts and … The Paradigm Biopharmaceuticals Ltd (ASX:PAR) share price is up more than 4%, trading at $2.51. Paradigm Biopharmaceuticals Ltd has made the first major submission for its planned Pivotal study in subjects with pain associated with Knee Osteoarthritis (OA) by submitting an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).. This study in 40 patients will administer ZILOSUL® twice weekly … Paradigm has registered trademarks for the BME product, ZILOSUL® and respiratory product RHINOSUL® for Allergic Rhinitis. As iPPS has a long track record of human use and safety data, Zilosul® can be accessed by Doctors treating their patients through the SAS program in Australia, or as subjects in Paradigm… 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. About. A Phase 2B clinical trial showed the drug reduces cartilage degradation. Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce a mean pain reduction of 65% at week 12 (Day 81-83), across the ten patients treated with Zilosul® under the FDA approved Expanded Access Program (EAP) in the US. ASX Announcement Paradigm Biopharmaceuticals Ltd (ASX:PAR) ABN: 94 169 346 963 Date: 3 December, 2015 Elite athlete from a major sporting code treated with Paradigm’s ZILOSUL® under the Therapeutic Goods Administration’s Special Access Scheme. By working closely with the proprietary manufacturer of PPS, we are able to leverage substantial knowledge and expertise available from earlier regulatory filings. Patents & Patent Applications. Subscribe. Data from an additional 13 patients who received Paradigm Biopharmaceuticals' (PAR) osteoarthritis treatment has shown a clinically significant reduction in pain. Paradigm’s, Zilosul® (IM or SC administered) provides an effective treatment for an unmet medical need to treat a large population of patients with osteoarthritis. Paradigm is pleased to report a 45% mean reduction in WOMAC pain subscale of the WOMAC Osteoarthritis index … Paradigm Biopharmaceuticals Ltd (ASX: PAR) The primary and secondary endpoints for Paradigm’s proposed phase 3 trial will be (i) reduced WOMAC pain from baseline and (ii) improved Patient Global Impression of Change (PGIC) at week 8 (Day 53). Paradigm Biopharmaceuticals Ltd has received positive feedback from the Type-C meeting with the US Food and Drug Administration (FDA) on Zilosul ® for the treatment of osteoarthritis.. 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. Please note that Paradigm Biopharmaceuticals Ltd is unable to provide medical advice to individuals, and any matters relating to your condition or treatment must be discussed with your GP or specialist. Paradigm Biopharmaceuticals Ltd continues to pursue 4 main patent families in the areas of: bone marrow edema (BME); mucopolysaccharidoses (MPS); alphaviral arthritis; and respiratory disease, including allergic … 65% Reduction (from baseline) in WOMAC Pain “Oral NSAID treatment and potent oral opioids (such as oxycodone) reduced pain with … What did Paradigm Biopharmaceuticals announce? Paradigm clinical trial results identify breakthrough in fight against osteoarthritis. Success: You have been added to our newsletter Error: Invalid email address. Osteoarthritis sufferers could soon receive effective pain relief and reduced onset from the degenerative disease after Paradigm Biopharmaceuticals (ASX: PAR) reported breakthrough clinical trial results which identified a significant reduction of pain levels from participants using their Zilosul … Latest insights and broker reports direct to your inbox. Prior to the end of 2019, Fiftyone Capital shared an update with our investors in the Progressive Global Fund regarding our holding Paradigm Biopharmaceuticals (ASX:PAR). We estimate a big pharma will seek a licensing deal for Zilosul® above US$2 Billion [total deal size] in 2019. BRIEF-Paradigm Biopharmaceuticals Says Completed Treatment Of Patients With Zilosul * COMPLETED TREATMENT OF ALL 10 PATIENTS WITH ZILOSUL UNDER FDA IND EXPANDED ACCESS PROGRAM With Paradigm only having released the top-line results from their phase 2b study, and no peer-reviewed journal published yet, the … 23 November 2015, Melbourne Australia: Paradigm Biopharmaceuticals Limited (ASX:PAR) has been granted approval by the Human Research Ethics Committee (HREC) to proceed with the open-label pilot clinical trial to determine the safety and tolerability of ZILOSUL® in patients with a BME lesion. The biotech company conducted research into PPS to prove that bone cells under the cartilage produce the pain mediator known as “NGF” and … HITTING THE BIG LEAGUES WITH THE NFL . Paradigm Biopharmaceuticals (PAR) is one step closer to launching phase three clinical trials after a meeting with the European Medicines Agency (EMA). 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.. Paradigm Biopharmaceuticals Ltd has dosed the first patient under the US FDA approved Expanded Access Program (EAP) with Zilosul®..