Hi everyone (or anyone who comes looking here). I'm starting this thread to introduce Paradigm and, in particular, its flagship drug Zilosul - injectable Pentosan Polysuphate Sodium (iPPS).
I will cheat a bit by copying some statements from Paradigm's website (this will have the added benefit of accuracy): Paradigm Biopharma home
Repurposing mission
Paradigm Biopharmaceuticals is a commercially focussed drug repurposing company. We take an existing approved drug, which has demonstrated safety in its approved indication/s and repurpose that drug in a new, patented therapeutic application addressing areas of high unmet medical need. With our extensive understanding of the scientific, clinical, regulatory, and commercial requirements of drug development, we can achieve a reduction in the time, cost and risk associated with taking new products to market.
Pentosan Polysuphate Sodium
Paradigm’s immediate commercial focus is the repurposing of Pentosan Polysulfate Sodium (PPS) for the treatment of Osteoarthritis (OA). This is a global unmet need and we have advanced to phase 3 trials in the space. Addressing all aspects of the disease: inflammation, pain and regeneration, PPS has genuine disease modifying potential.
Back to my wording (and opinion)... PPS has been used successfully for several decades to treat OA in dogs, cats and horses. It has long been used in humans for the treatment of Interstitial cystitis. iPPS more recently has been available in limited cases in Australia to treat OA under the TGA's Special Access Scheme (SAS)
We know it works, and works very well, and has a proven safety profile. It simply isn't widely approved for human OA yet as nobody previously has expended the funds and gone to the years long effort to obtain widespread approval.
Paradigm has so far progressed to Phase 3 in trials for approval in the USA, Europe and Australia. Our company has secured exclusive supply of the drug - a drug which is extremely difficult to copy in the correct molecular form required by the FDA.
Given this exclusivity, the track record of successful treatment through the SAS, and the long safety history, Paradigm's profile presents an assymetric investment opportunity (in my humble opinion). Like always, don't rely on my opinion and I do encourage interested readers to do their own research.
I will cheat a bit by copying some statements from Paradigm's website (this will have the added benefit of accuracy): Paradigm Biopharma home
Repurposing mission
Paradigm Biopharmaceuticals is a commercially focussed drug repurposing company. We take an existing approved drug, which has demonstrated safety in its approved indication/s and repurpose that drug in a new, patented therapeutic application addressing areas of high unmet medical need. With our extensive understanding of the scientific, clinical, regulatory, and commercial requirements of drug development, we can achieve a reduction in the time, cost and risk associated with taking new products to market.
Pentosan Polysuphate Sodium
Paradigm’s immediate commercial focus is the repurposing of Pentosan Polysulfate Sodium (PPS) for the treatment of Osteoarthritis (OA). This is a global unmet need and we have advanced to phase 3 trials in the space. Addressing all aspects of the disease: inflammation, pain and regeneration, PPS has genuine disease modifying potential.
Back to my wording (and opinion)... PPS has been used successfully for several decades to treat OA in dogs, cats and horses. It has long been used in humans for the treatment of Interstitial cystitis. iPPS more recently has been available in limited cases in Australia to treat OA under the TGA's Special Access Scheme (SAS)
We know it works, and works very well, and has a proven safety profile. It simply isn't widely approved for human OA yet as nobody previously has expended the funds and gone to the years long effort to obtain widespread approval.
Paradigm has so far progressed to Phase 3 in trials for approval in the USA, Europe and Australia. Our company has secured exclusive supply of the drug - a drug which is extremely difficult to copy in the correct molecular form required by the FDA.
Given this exclusivity, the track record of successful treatment through the SAS, and the long safety history, Paradigm's profile presents an assymetric investment opportunity (in my humble opinion). Like always, don't rely on my opinion and I do encourage interested readers to do their own research.
