Pentosan polysulfate - Paradigm Biopharma
Alternative Names: Pentosan polysulfate sodium - Paradigm Biopharma; PPS - Paradigm Biopharma; Rhinosul; ZILOSUL; ZilosulLatest Information Update: 29 Dec 2023
At a glance
- Originator Glycan Biosciences; Griffith University
- Developer Griffith University; Paradigm Biopharma
- Class Analgesics; Anti-inflammatories; Antiallergics; Anticoagulants; Antihyperlipidaemics; Antiretrovirals; Antithrombotics; Antivirals; Glycosaminoglycans; Polymers; Polysaccharides; Small molecules; Sulfuric acids
- Mechanism of Action Cell membrane permeability inhibitors; Enzyme inhibitors; Non-nucleoside reverse transcriptase inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Phase III Pain
- Phase II Mucopolysaccharidosis VI; Ross River virus infections; Seasonal allergic rhinitis
- Phase I/II Mucopolysaccharidosis I; Oedema
- Preclinical Osteoarthritis
- No development reported Allergic asthma; Allergic rhinitis; Chikungunya virus infections; Chronic obstructive pulmonary disease
Most Recent Events
- 10 Nov 2023 Preclinical trials in Osteoarthritis in Australia (SC) prior to November 2023
- 10 Nov 2023 Pharmacodynamics and adverse events data from preclinical studies in Osteoarthritis presented at the ACR Convergence 2023 (ACR-ARP-2023) )
- 12 Aug 2022 Pentosan polysulfate - Paradigm Biopharma is available for licensing as of 12 Aug 2022. www.paradigmbiopharma.com 9365973
Development Overview
Introduction
Repurposed formulations of sulfated polysaccharide, pentosan polysulfate sodium (PPS), is being developed by Paradigm Biopharma for the treatment of inflammatory disease, including bone marrow oedema, Ross River virus infections, chikungunya virus infections, mucopolysaccharidosis type I, mucopolysaccharidosis type VI, and respiratory diseases, including allergic rhinitis, allergic asthma and chronic obstructive pulmonary disease (COPD) and osteoarthriitis. PPS, 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. The reformulated drug will follow 505(b)(2) pathway in the US. Clinical and preclinical development is ongoing in several countries worldwide.
As of August 2022, Paradigm Biopharma is looking for strategic partnerships to progress current and future clinical studies to further evaluate pentosan polysulfate sodium as a treatment to metabolic disorders [1] .
Phase I development in allergic rhinitis and preclinical development in Chikungunya virus infections, allergic asthma was conducted in Australia. Early research development in chronic obstructive pulmonary disease was also conducted in Australia. As at October 2020, no recent reports of development were identified.
Company Agreements
Paradigm Biopharma and Griffith University enters into a licensing and assignment agreement, whereby the former acquired exclusive worldwide rights for commercialisation of the latter's patent, covering the use of pentosan polysulfate for the treatment of Ross River virus- and Chikungunya virus-induced arthritis and arthralgia, and the former is also entitled to acquire the patent after a phase II trial. [2]
In August 2015, Paradigm Biopharma completed the purchase the IP assets, including the use of pentosan polysulfate for treatment of allergic ahinitis, allergic asthma and chronic obstructive pulmonary disease, Glycan Biosciences (Paradigm Biopharma Annual Report, 2015).
Key Development Milestones
In April 2022, the US FDA has granted fast track designation for the phase III program investigating pentosan polysulfate sodium (PPS) for the treatment of with knee osteoarthritis pain [3]
In December 2021, Paradigm Biopharma initiated an extension phase III study to evaluate the duration of treatment effect and re-treatment of pentosan polysulfate sodium in patients with knee osteoarthritis pain, compared with placebo (PARA_OA_006; NCT04814719). The primary endpoint is a change from baseline at day 56 in WOMAC® pain with secondary outcomes including change from baseline at multiple time points out to day 168 in WOMAC® pain and function, patient global impression of change and quality of life. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 938 patients in Australia and the US, and may expands to the UK, the EU countries [4] [5] .
In March 2021, Paradigm Biopharmaceuticals initiated a phase II/III trial to evaluate the dose and treatment effect of pentosan polysulfate sodium compared with placebo in participants with knee osteoarthritis pain (PARA_OA_002; ACTRN12621000136808; NCT04809376). First patient in the trial is dosed in May 2022. The randomised, double blind trial intends to enrol approximately 938 patients in Australia and the US [6] [7] .
Prior to October 2022, Paradigm Biopharma initiated a phase II clinical trial to evaluate the treatment effects of iPPS on synovial fluid biomarkers associated with osteoarthritis related pain, inflammation, and disease progression in humans (PARA_OA_008). The randomised trial intends to enrol approximately 61 patients [8] .
Prior to August 2022, Paradigm Biopharma initiated a phase II clinical trial for the treatment of patients with mucopolysaccharidosis type VI (MPS-VI). The primary endpoint is evaluation of safety, and the secondary endpoints are improvements in pain and function. The double-blinded, randomised and placebo controlled trial intends to enrol approximately 12 patients in Brazil. In August 2022, initial adverse events data from the trial were released by the company. As of August 2022, the Safety Monitoring Physician for the study confirmed successful evaluation of patients aged 16 and above, and the study is now scheduled to assess PPS in two younger cohorts (9 to 16 years, then following another safety review, 5 to 9 years). Additionally, a 5-year extension program is being offered to patients after completion of the trial [1] [9] .
In January 2019, Paradigm Biopharmaceuticals completed the phase II PARA005 trial which evaluated the effects of pentosan polysulfate sodium, on treating pain in subjects with osteoarthritis of the knee and subchondral bone marrow lesions (373400; ACTRN12617001311347). Evaluation of the change in KOOS pain score from baseline to day 53 was the defined primary endpoint of the trial. The randomised, double-blind, placebo-controlled trial that was initiated in October 2017, enrolled 126 patients in Australia [10] .
In November 2018, Paradigm Biopharma completed a phase II trial that evaluated the safety and tolerability of subcutaneous pentosan polysulfate sodium (PPS) in patients with ross river virus induced arthralgia (2017-03-235; 372925; ACTRN12617000893303, PARA_004). The randomised, double-blind trial, initiated in July 2017, enrolled 20 patients in Australia [11] .
Paradigm Biopharma, in March 2017, completed a phase II trial that evaluated the safety and the effects of pentosan polysulphate nasal spray on post-challenge nasal symptoms using an allergen challenge model in patients with seasonal allergic rhinitis (PARA_003; EudraCT2016-003341-28). The randomised, double-blind, placebo-controlled, crossover study was initiated in November 2016 and enrolled 40 patients in Sweden [12] .
In September 2020, Paradigm Biopharma initiated a phase I/II trial to evaluate the safety and tolerability of pentosan polysulfate sodium in subjects with mucopolysaccharidosis type I (MPS-I) (379536; ACTRN12620000823976). The open-label, pilot trial intends to enrol 10 patients in Australia [13] . In August 2022, initial results from the trial were released by the company [1] .
In February 2016, Paradigm Biopharma initiated a phase I/II trial to evaluate the safety and tolerability of intramuscular injections of pentosan polysulfate for the treatment of bone marrow lesions of the knee (ACTRN12616000009415). The open-label trial is designed to enrol approximately 40 patients in Australia.
In november 2020, Paradigm Biopharma completed a phase I trial that evaluated the safety, tolerability and pharmacokinetics of subcutaneous pentosan solysulfate sodium (PPS) in volunteers (2020-06-534; 379531; ACTRN12620000829910). The open label trial was initiated in September 2020 and enrolled 23 volunteers in Australia [14]
In July 2016, Paradigm Biopharma completed a phase I trial which evaluated the safety and tolerability of single and multiple doses of intranasal pentosan polysulfate in healthy volunteers (PARA_002; ACTRN12616000676415). The randomised, double-blinded trial was initiated in June 2016, and enrolled 18 volunteers in Australia [15] .
In November 2023, Paradigm Biopharma presented preclinical data of pentosan polysulfate sodium at the ACR Convergence 2023 (ACR-ARP-2023) [16]
Under the TGA Special Access Scheme, pentosan polysulfate demonstrated favourable tolerability and potential clinical effects in patients with Ross River virus infection-induced arthralgia (Paradigm Biopharma Presentation, March 2017). Preclinical studies, conducted at the Griffith University, demonstrated that pentosan polysulfate was safe and effective in mouse models of Ross River virus infections and chikungunya infections [2] .
Paradigm Biopharma is investigating pentosan polysulfate for the treatment of allergic asthma and COPD (Paradigm Biopharma website and pipeline, April 2017).
Drug Properties & Chemical Synopsis
- Route of administration IM, Intranasal, SC
- Formulation Injection, Spray, unspecified
- Class Analgesics, Anti-inflammatories, Antiallergics, Anticoagulants, Antihyperlipidaemics, Antiretrovirals, Antithrombotics, Antivirals, Glycosaminoglycans, Polymers, Polysaccharides, Small molecules, Sulfuric acids
- Target Cell membrane permeability; Enzyme; Non-nucleoside reverse transcriptase
- Mechanism of Action Cell membrane permeability inhibitors; Enzyme inhibitors; Non-nucleoside reverse transcriptase inhibitors
-
WHO ATC code
A16 (Other Alimentary Tract and Metabolism Products)
J05 (Antivirals for Systemic Use)
M01 (Antiinflammatory and Antirheumatic Products)
M01A-X (Other antiinflammatory and antirheumatic agents, non-steroids)
N02 (Analgesics)
R01A-X (Other nasal preparations)
-
EPhMRA code
A16 (Other Alimentary Tract and Metabolism Products)
J5 (Antivirals for Systemic Use)
M1 (Anti-Inflammatory and Anti-Rheumatic Products)
N2 (Analgesics)
R1A9 (Other topical nasal preparations)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Allergic asthma | - | - | No development reported (Preclinical) | Australia | Intranasal / Spray | Paradigm Biopharma | 28 Oct 2019 |
| Allergic rhinitis | - | In volunteers | No development reported (I) | Australia | Intranasal / Spray | Paradigm Biopharma | 28 Jul 2019 |
| Chikungunya virus infections | - | - | No development reported (Preclinical) | Australia | unspecified / unspecified | Griffith University | 28 Oct 2020 |
| Chronic obstructive pulmonary disease | - | - | No development reported (Research) | Australia | Intranasal / Spray | Paradigm Biopharma | 28 Oct 2019 |
| Mucopolysaccharidosis I | pain and arthropathy associated with Mucopolysaccharidosis-I | Adjunctive treatment, In adolescents, In adults, In children, In the elderly, Treatment-experienced | Phase I/II | Australia | SC / Injection | Paradigm Biopharma | 09 Sep 2020 |
| Mucopolysaccharidosis VI | - | Adjunctive treatment, In adolescents, In adults, In children, In the elderly | Phase II | Brazil | SC / Injection | Paradigm Biopharma | 12 Aug 2022 |
| Oedema | Bone oedema lesions | - | Phase I/II | Australia | IM / Injection | Paradigm Biopharma | 20 Feb 2016 |
| Osteoarthritis | - | - | Preclinical | Australia | SC / Injection | Paradigm Biopharma | 10 Nov 2023 |
| Pain | in patients with osteoarthritis of the knee | - | Phase III | Australia, USA (fast track) | SC / Injection | Paradigm Biopharma | 17 Mar 2022 |
| Ross River virus infections | - | - | Phase II | Australia | SC / Injection | Paradigm Biopharma | 20 Jul 2017 |
| Seasonal allergic rhinitis | - | - | Phase II | Sweden | Intranasal / Spray | Paradigm Biopharma | 14 Nov 2016 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Pain |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Griffith University | Originator | Australia |
| Glycan Biosciences | Originator | USA |
| Griffith University | Owner | Australia |
| Glycan Biosciences | Owner | USA |
| Paradigm Biopharma | Licensee | Australia |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Paradigm Biopharma | - | Unspecified | - | 12 Aug 2022 |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Rhinosul | Paradigm Pharmaceuticals | Allergic rhinitis | Australia |
| ZILOSUL | Paradigm Biopharma | Oedema | Australia |
| Zilosul | Paradigm Biopharma | Mucopolysaccharidosis I, Pain | USA |
Scientific Summary
Adverse Events
Initial safety data from a phase II clinical trial in patients (n=3) with mucopolysaccharidosis type VI demonstrated no serious adverse events upon weekly dosing of pentosan polysulfate sodium [1] [9] .
In a phase I/II clinical trial, pentosan polysulfate sodium in patients (n=4) with mucopolysaccharidosis type I was well tolerated at weekly doses of 0.75 and 1.5 mg/kg for 47 weeks. Three patients completed the 48-week treatment regimen with no serious adverse events reported to date [1] [13] .
In preclinical studies, pentosan polysulfate (PPS) therapy was well tolerated during treatment and follow up [16]
Pharmacodynamics
In preclinical studies, the long-term effect of pentosan polysulfate (PPS) therapy resulted in the improvement of pain, function, cartilage volume and serum biomarkers at 26 weeks from baseline suggesting that PPS stabilised disease progression in canine osteoarthritis. Pentosan polysulfate treatment showed meaningful effect size (ES) improvement in pain at week 26 compared to placebo with a reduction in mean percentage change from the previous follow-up at week 8 in HCPI (ES 1.79). The improvement in pain was reflected by a larger effect size at the later time of 26 weeks relative to week 8 (ES 0.39) suggesting durability of PPS effects on pain. Long-term functional improvements in gait were demonstrated by an increase in mean %CFB in TPI% and sustained by ES of 0.55 and 0.5 at weeks 8 and 26, respectively. Furthermore, the mean %CFB in TPI% for PPS treatment at weeks 8 and 26 was 7.3% and 8.2%, respectively, whereas clinically meaningful increases reported at 5% were not met by placebo. There were larger reductions in cartilage volume in the placebo group compared to PPS treatment at 8 and 26 weeks with a large PPS ES of 1.06 and 0.73, respectively suggesting reduction in structural degeneration of the articular cartilage. PPS favourably affected serum levels of CTX-1, HA and TIMP-1 supporting the in vivo mechanisms of drug action [16]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 24 Dec 2021 | Trial Update | Paradigm Biopharmaceuticals plans a phase III extension trial in Pain (associated with knee osteoarthritis) in Australia and USA in December 2021 (SC, Injection) (NCT04814719) | 01 Apr 2022 |
| 31 Mar 2021 | Trial Update | Paradigm plans a phase II trial for Pain (In adults, In the elderly) in Australia (SC) in March 2021 (ACTRN12621000136808p) | 08 Jul 2021 |
| 09 Sep 2020 | Trial Update | Paradigm Biopharmaceuticals plans a phase I pharmacokinetics trial of Pentosan polysulfate (In volunteers, In adults, In the elderly) (SC) in Australia (ACTRN12620000829910) (700326855) | 19 Oct 2020 |
| 31 Aug 2020 | Trial Update | Paradigm Biopharma plans a phase I/II trial in Mucopolysaccharidosis-I (Treatment-experienced, In children, In adolescents, In adults, In the elderly) in Australia (SC) in August 2020 (ACTRN12620000823976) (700326782) | 09 Oct 2020 |
| 31 Dec 2017 | Trial Update | Paradigm plans a phase II trial for Chikungunya virus infection-induced arthritis and arthralgia in the second half of 2017 (Paradigm Biopharma Presentation, March 2017) | 04 Apr 2017 |
| 02 Oct 2017 | Trial Update | Paradigm Biopharmaceuticals plans the PARA005 phase II trial for Pain in Australia (ACTRN12617001311347 ) | 22 Dec 2017 |
| 30 Aug 2017 | Trial Update | Paradigm Biopharma plans a double-blind clinical trial in 60 patients with Bone marrow lesions associated with knee osteoarthritis in the second quarter of 2017 (Paradigm Biopharma website, April 2017) | 25 Jul 2017 |
| 30 Aug 2017 | Trial Update | Paradigm plans a phase II trial for Ross River virus infection-induced arthritis and arthralgia (Paradigm Biopharma Presentation, March 2017) | 19 Sep 2022 |
| 10 Jul 2017 | Trial Update | Paradigm Biopharma plans a phase II trial for Ross River virus infections in Australia (ACTRN12617000893303) | 25 Jul 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 10 Nov 2023 | Phase Change - Preclinical | Preclinical trials in Osteoarthritis in Australia (SC) prior to November 2023 [16] Updated 29 Dec 2023 |
| 10 Nov 2023 | Scientific Update | Pharmacodynamics and adverse events data from preclinical studies in Osteoarthritis presented at the ACR Convergence 2023 (ACR-ARP-2023) ) [16] Updated 29 Dec 2023 |
| 12 Aug 2022 | Licensing Status | Pentosan polysulfate - Paradigm Biopharma is available for licensing as of 12 Aug 2022. www.paradigmbiopharma.com 9365973 Updated 22 Aug 2022 |
| 12 Aug 2022 | Phase Change - II | Phase-II clinical trials in Mucopolysaccharidosis VI (In adolescents, In adults, In children, In the elderly, Adjunctive treatment) in Brazil (SC), prior to August 2022 [1] Updated 22 Aug 2022 |
| 12 Aug 2022 | Scientific Update | Initial efficacy and adverse events data from a phase I/II trial in Mucopolysaccharidosis type I released by Paradigm Biopharma [1] Updated 22 Aug 2022 |
| 12 Aug 2022 | Scientific Update | Initial adverse events data from a phase II trial in Mucopolysaccharidosis type VI released by Paradigm Biopharma [1] Updated 22 Aug 2022 |
| 13 Apr 2022 | Regulatory Status | Pentosan polysulfate - Paradigm Biopharma receives Fast Track designation for Pain [SC,Injection] in USA [3] Updated 20 Apr 2022 |
| 24 Dec 2021 | Phase Change - III | Phase-III clinical trials in Pain in Australia (SC) (NCT04814719) Updated 01 Apr 2022 |
| 24 Dec 2021 | Phase Change - III | Phase-III clinical trials in Pain in USA (SC) [4] (NCT04814719) Updated 23 Mar 2022 |
| 19 Oct 2021 | Trial Update | Paradigm Biopharmaceuticals initiates enrolment in a phase II/III clinical trials in Pain in USA (SC, Injection), after October 2019 (NCT04809376) Updated 10 May 2022 |
| 12 Apr 2021 | Phase Change - II/III | Phase-II/III clinical trials in Pain in Australia (SC) (ACTRN12621000136808) Updated 08 Jul 2021 |
| 24 Mar 2021 | Trial Update | Paradigm Biopharmaceuticals plans a phase III extension trial in Pain (associated with knee osteoarthritis) in Australia and USA in December 2021 (SC, Injection) (NCT04814719) Updated 01 Apr 2022 |
| 11 Feb 2021 | Trial Update | Paradigm plans a phase II trial for Pain (In adults, In the elderly) in Australia (SC) in March 2021 (ACTRN12621000136808p) Updated 08 Jul 2021 |
| 05 Nov 2020 | Trial Update | Paradigm Biopharmaceuticals completes a phase I pharmacokinetics trial of Pentosan polysulfate (In volunteers, In adults, In the elderly) (SC) in Australia (ACTRN12620000829910) Updated 02 Jul 2021 |
| 28 Oct 2020 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Chikungunya-virus-infections in Australia Updated 28 Oct 2020 |
| 09 Sep 2020 | Trial Update | Paradigm Biopharmaceuticals initiates a phase I pharmacokinetics trial of Pentosan polysulfate (In volunteers, In adults, In the elderly) (SC) in Australia (ACTRN12620000829910) Updated 19 Oct 2020 |
| 09 Sep 2020 | Phase Change - I/II | Phase-I/II clinical trials in Mucopolysaccharidosis I (Treatment-experienced, In children, In adults, In adolescents, In the elderly) in Australia (SC) (ACTRN12620000823976) Updated 09 Oct 2020 |
| 21 Aug 2020 | Trial Update | Paradigm Biopharmaceuticals plans a phase I pharmacokinetics trial of Pentosan polysulfate (In volunteers, In adults, In the elderly) (SC) in Australia (ACTRN12620000829910) Updated 19 Oct 2020 |
| 31 Mar 2020 | Trial Update | Paradigm Biopharma plans a phase I/II trial in Mucopolysaccharidosis-I (Treatment-experienced, In children, In adolescents, In adults, In the elderly) in Australia (SC) in August 2020 (ACTRN12620000823976) Updated 09 Oct 2020 |
| 28 Oct 2019 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Allergic-asthma in Australia (Intranasal, Spray) Updated 28 Oct 2019 |
| 28 Oct 2019 | Phase Change - No development reported | No recent reports of development identified for research development in Chronic-obstructive-pulmonary-disease in Australia (Intranasal, Spray) Updated 28 Oct 2019 |
| 28 Jul 2019 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Allergic-rhinitis(In volunteers) in Australia (Intranasal, Spray) Updated 28 Jul 2019 |
| 07 Jan 2019 | Trial Update | Paradigm Biopharma completes the phase II PARA005 trial in Pain (associated with osteoarthritis) in Australia (ACTRN12617001311347) Updated 15 Apr 2019 |
| 05 Nov 2018 | Trial Update | Paradigm Biopharmaceuticals completes a phase-II trial in Ross River virus infections in Australia (SC) (ACTRN12617000893303) Updated 16 Apr 2019 |
| 27 Oct 2017 | Phase Change - II | Phase-II clinical trials in Pain in Australia (SC) (ACTRN12617001311347) Updated 22 Dec 2017 |
| 18 Sep 2017 | Trial Update | Paradigm Biopharmaceuticals plans the PARA005 phase II trial for Pain in Australia (ACTRN12617001311347 ) Updated 22 Dec 2017 |
| 20 Jul 2017 | Phase Change - II | Phase-II clinical trials in Ross River virus infections in Australia (SC) (ACTRN12617000893303) Updated 25 Jul 2017 |
| 22 Jun 2017 | Trial Update | Paradigm Biopharma plans a phase II trial for Ross River virus infections in Australia (ACTRN12617000893303) Updated 25 Jul 2017 |
| 04 Apr 2017 | Trial Update | Paradigm plans a phase II trial for Ross River virus infection-induced arthritis and arthralgia (Paradigm Biopharma Presentation, March 2017) Updated 19 Sep 2022 |
| 04 Apr 2017 | Trial Update | Paradigm Biopharma plans a double-blind clinical trial in 60 patients with Bone marrow lesions associated with knee osteoarthritis in the second quarter of 2017 (Paradigm Biopharma website, April 2017) Updated 25 Jul 2017 |
| 04 Apr 2017 | Trial Update | Paradigm plans a phase II trial for Chikungunya virus infection-induced arthritis and arthralgia in the second half of 2017 (Paradigm Biopharma Presentation, March 2017) Updated 04 Apr 2017 |
| 22 Mar 2017 | Trial Update | Paradigm Pharmaceuticals completes a phase II trial in Seasonal allergic rhinitis in Sweden (Intranasal) (EudraCT2016-003341-28) Updated 15 Jun 2017 |
| 14 Nov 2016 | Phase Change - II | Phase-II clinical trials in Seasonal allergic rhinitis in Sweden (Intranasal) (EudraCT2016-003341-28) Updated 21 Dec 2016 |
| 07 Sep 2016 | Licensing Status | Paradigm Biopharmaceuticals and Griffith University enters into a licensing and assignment agreement for commercialisation and development of pentosan polysulfate for the treatment of Ross River virus- and Chikungunya virus-induced arthritis and arthralgia [2] Updated 05 Apr 2017 |
| 07 Sep 2016 | Phase Change - Clinical | Clinical trials in Ross River virus infections in Australia (unspecified route) Updated 04 Apr 2017 |
| 07 Sep 2016 | Phase Change - Preclinical | Preclinical trials in Chikungunya virus infections in Australia (unspecified route) Updated 04 Apr 2017 |
| 06 Sep 2016 | Phase Change - Preclinical | Preclinical trials in Ross River virus infections in Australia (unspecified route) before September 2016 Updated 05 Apr 2017 |
| 21 Jul 2016 | Trial Update | Paradigm Biopharmaceuticals completes a phase-I trial in Allergic rhinitis (In volunteers) in Australia (Intranasal) (ACTRN12616000676415) Updated 27 Sep 2016 |
| 20 Jun 2016 | Phase Change - I | Phase-I clinical trials in Allergic rhinitis (In volunteers) in Australia (Intranasal) (ACTRN12616000676415) Updated 12 Jul 2016 |
| 01 Jun 2016 | Phase Change - Preclinical | Preclinical trials in Allergic rhinitis in Australia (Intranasal) (ACTRN12616000676415p) before June 2016 Updated 15 Jun 2016 |
| 19 May 2016 | Trial Update | Paradigm Biopharmaceuticals plans a phase I trial for Allergic rhinitis (In volunteers) in Australia (ACTRN12616000676415p) Updated 14 Jun 2016 |
| 20 Feb 2016 | Phase Change - I/II | Phase I/II trials in Oedema in Australia (IM) Updated 04 Apr 2017 |
| 05 Aug 2015 | Phase Change | Early research in Chronic obstructive pulmonary disease in Australia (Intranasal) Updated 06 Apr 2017 |
| 05 Aug 2015 | Phase Change - Preclinical | Preclinical trials in Allergic asthma in Australia (Intranasal) Updated 06 Apr 2017 |
| 05 Aug 2015 | Licensing Status | Paradigm Biopharma and Glycan Biosciences completes an asset purchase agreement for pentosan polysulfate for the treatment of allergic rhinitis, allergic asthma and chronic obstructive pulmonary disease (Paradigm Biopharma Annual Report, Updated 05 Apr 2017 |
References
-
MPS Clinical Program Update and Paradigm to Present at the International Conference on Lysosomal Diseases.
Media Release -
Paradigm's PPS as a potential breakthrough in the treatment of viral arthritis and joint pain.
Media Release -
FDA Grants Fast Track Designation for Paradigm Biopharmaceuticals Phase III Osteoarthritis Program.
Media Release -
Paradigm Biopharmaceuticals Initiates a Phase 3 Clinical Trial in Knee Osteoarthritis Across the U.S.
Media Release -
An Extension Study to Evaluate Duration of Treatment Effect and Re-treatment of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
ctiprofile -
First Subjects Randomized and Dosed in the U.S. under Phase III Pivotal Trial for the Treatment of Pain Associated with Knee OA.
Media Release -
A Phase 2, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo on Synovial Fluid Biomarkers in Participants with Knee Osteoarthritis Pain
ctiprofile -
Paradigm Achieves Primary Endpoint in PARA_OA_008 Synovial Fluid Biomarker Phase 2 Clinical Trial.
Media Release -
A multi-centre, randomized, double-blind, placebo-controlled phase 2 trial of pentosan polysulfate sodium in patients with MPS-VI
ctiprofile -
A phase 2b, randomised double blind placebo controlled multicentre study to evaluate the effects of pentosan polysulfate sodium on treating pain in subjects with osteoarthritis of the knee and subchondral bone marrow lesions
ctiprofile -
A pilot study to investigate the effects of pentosan polysulfate sodium in Ross River virus induced arthralgia
ctiprofile -
A phase 2, randomised, double-blind, placebo-controlled, crossover study to evaluate the effects of a topical pentosan polysulphate sodium (PPS) formulation in subjects with seasonal allergic rhinitis
ctiprofile -
An open-label single-centre pilot study to evaluate the safety and tolerability of pentosan polysulfate sodium in subjects with mucopolysaccharidosis type I (MPS I)
ctiprofile -
A Phase 1, Open-label Study to Determine the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Doses of Pentosan Polysulfate Sodium (PPS) in Healthy Adult Participants
ctiprofile -
Phase I study to evaluate the safety and tolerability of single and multiple doses of intranasal pentosan polysulfate (Rhinosul 'Trademark') in healthy subjects
ctiprofile -
Krishnan R, Stapledon C, Reiter C, Ryan S, Bauquier S, Beths T. Pentosan Polysulfate Sodium, a Glycosaminoglycan Mimetic Demonstrates Durable Effects on Pain, Function and Joint Structure in Canine Naturally Occurring Osteoarthritis. ACR-ARP-2023 2023; abstr. 0867.
Available from: URL: https://acrabstracts.org/abstract/pentosan-polysulfate-sodium-a-glycosaminoglycan-mimetic-demonstrates-durable-effects-on-pain-function-and-joint-structure-in-canine-naturally-occurring-osteoarthritis/
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG