Company
Paradigm Biopharmaceuticals Ltd
ASX:PAR
Paradigm Biopharmaceuticals Ltd (ASX:PAR) is a drug repurposing company driven by core competencies and experience at board and executive level in clinical and commercial pharmaceutical development. The company’s approach is to take an existing approved drug, which has demonstrated safety in its approved indications, and repurposing the drug in a new patented therapeutic application. Paradigm’s pipeline indications cover the use of pharmaceutical compound Pentosan Polysulfate Sodium (PPS), supported by full patent and IP protection and its immediate commercial focus is the repurposing of PPS for the treatment of Osteoarthritis (OA).
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Paradigm Biopharmaceuticals appoints Paul Rennie as MD after CEO Marco Polizzi steps down
The company's founder and non-executive chairman Paul Rennie will take the reins as MD during the transition period and thereafter.
Paradigm Biopharmaceuticals’ clinical trial data on injectable PPS in metabolic disease to feature at WORLDSymposium 2023
“The data from this trial will be invaluable for further development for potential registration of iPPS for this indication,” said CEO Marco Polizzi.
Paradigm Biopharmaceuticals begins dosing first UK subject in pivotal iPPS/Zilosul® trial
The purpose of this phase three study is to establish the efficacy of subcutaneous injections of PPS (iPPS) participants with knee osteoarthritis pain.
Paradigm Biopharmaceuticals achieves high levels of pain reduction in PARA_OA_008 osteoarthritis trial; shares jump
“These are meaningful signals that we will evaluate together with clinical and imaging outcomes in order to demonstrate disease-modifying effects and to pursue regulatory authority guidance on a disease-modifying pathway," said chief medica
Paradigm Biopharmaceuticals passes milestone on completing safety review for MPS VI phase 2 clinical trial
This milestone now allows the inclusion of subjects aged 5 to 9 years to assess the safety and tolerability of PPS amongst this paediatric population.
Paradigm Biopharmaceuticals closes A$20.3 million entitlement offer, raising A$66 million in total
The fully underwritten placement and offer are set to give PAR a proforma cash position of A$108.5 million to fund it into 2024.
Paradigm Biopharmaceuticals appoints interim company secretary
Abby Macnish has been appointed to the role in an interim capacity following the passing of long-term company secretary Kevin Hollingsworth.
Paradigm Biopharmaceuticals to raise $66 million to fund it through to CY24
The placement received strong participation from domestic and offshore institutional investors and once completed, a global long only institutional investor will become a substantial shareholder.
Paradigm Biopharmaceuticals invited to present on pentosan polysulfate sodium at lysosomal diseases conference
“We are very excited by the global recognition of Paradigm’s clinical development in this rare disease and the opportunity to present the exciting work we are undertaking at the International Conference on Lysosomal Diseases early next year
Paradigm Biopharmaceuticals signs OA research agreement with major US sporting organisation
The company has entered a research partnership with NFL Alumni Health which has more than 10,000 members and represents former NFL players and coaches.
Paradigm Biopharmaceuticals begins UK-based screening for Phase 3 study assessing Zilosul® on knee OA
“The interaction with Health Canada was positive throughout the regulatory process and the company looks forward to announcing anticipated ethics approval and subsequent participant recruitment in Canada," chief medical officer Dr Donna Ske
Paradigm Biopharma completes recruitment for study assessing Zilosul® mechanism and disease modifying effects
“Paradigm looks forward to sharing early data outcomes in third quarter 2022 from this exciting exploratory study as well as our continued progress in the ongoing global Phase 3 clinical trial," chief medical officer Dr Donna Skerrett said.
Paradigm Biopharmaceuticals lands IP Australia approval for bone marrow pathology treatment patent
“It is very exciting for the company’s strategic plans to have a patent which claims the treatment of people with osteoarthritis and bone marrow lesions with pentosan polysulphate sodium (PPS) and we expect further acceptance and grants in
Paradigm Biopharmaceuticals receives $8.2 million R&D refund
The money will be used towards PAR’s research activities moving forward and will support its global Phase 3 clinical program in OA and Phase 2 clinical program in MPS, as well as ongoing pre-clinical programs.
Paradigm Biopharmaceuticals targets growth with appointment of US-based Marco Polizzi as CEO
“We are confident that this experience will provide significant development and commercial value to Paradigm. Marco will commence his tenure with Paradigm on July 1. He will be based in the United States and travel to Australia, Europe and
Paradigm Biopharmaceuticals doses first US subjects in Phase 3 pivotal trial for treatment of knee osteoarthritis pain
“To have our first subjects randomised in the US is an important milestone in the OA clinical program. We look forward to continuing the strong momentum in the phase 3 program and reporting important recruitment milestones to our shareholde
Paradigm Biopharmaceuticals secures US FDA fast-track for phase three osteoarthritis program
“Paradigm believes Zilosul™ would represent an important medical advance in the treatment of debilitating osteoarthritis pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications,”
Paradigm Biopharmaceuticals secures regulatory and ethics approval for phase three UK trial, shares up
Paradigm is ready to commence clinical trial site activation in the UK, and it expects to begin enrolling participants with knee osteoarthritis across five sites.
Paradigm BioPharma welcomes presentation by medical investigators on PPS as a treatment for unmet MPS VI needs
“The level of interest from potential licensing partners in Paradigm’s MPS clinical program is encouraging, with several meetings scheduled during the conference.” said Paradigm global head of safety and head of MPS Dr Michael Imperiale.
Paradigm Biopharmaceuticals osteoarthritis injectable trial proceeds to Phase 3 with an eye on US market
The company hopes to address vast unmet need in osteoarthritis patients across the developed world, where an estimated 120 million people are expected to be afflicted with this painful disease by 2030.
Paradigm Biopharma’s PPS heart failure treatment generates promising data from pre-clinical animal model trial
“Heart failure with preserved ejection fraction is an unmet medical need requiring urgent therapeutic attention. We are very pleased that the pilot study conducted in the laboratory of Dr Maria Vistnes has provided cutting edge data to furt
Paradigm Biopharmaceuticals to present positive data from phase 2 rare disease trial at international congress
PPS was well tolerated with no serious adverse events reported over a 24-week period and there were meaningful improvements in pain, function and activities of daily living while an overall improvement in quality of life was observed in all
Paradigm Biopharmaceuticals founder and CEO Paul Rennie transitions to non-executive chairman
The company has initiated a search for a new CEO with global pharma experience and has already identified a number of potential candidates.
Paradigm Biopharmaceuticals boosts R&D efforts with appointment of highly regarded doctor
Dr Christian Reiter’s "extensive knowledge base and experience with PPS will be great value to Paradigm’s R&D projects in developing new pipeline and second-generation products, as well as Paradigm’s OA and MPS programs," Paradigm CSO Dr Ra
Paradigm Biopharmaceuticals’ global market research shows Zilosul® knee osteoarthritis therapy has “blockbuster” potential
After conducting market research across four major global markets to determine the willingness of patients to pay for and doctors to prescribe Zilosul®, the company found broad approval for the treatment, suggesting an acceptable market pri
Paradigm Biopharmaceuticals receives US FDA clearance to begin Phase 3 clinical trial for knee osteoarthritis treatment
“The opening of the trial in the USA – the largest global pharmaceutical market, is a major milestone. This represents a substantial de-risking of the company's lead clinical program and is a testament to the company's expertise, commitment
Paradigm Biopharmaceuticals releases positive top-line preclinical study results for PPS treatment in acute respiratory distress syndrome
The complete set of results, including confirmatory studies will be prepared for peer review and publishing. Paradigm has filed a patent for the treatment of ARDS with PPS.
Paradigm Biopharmaceuticals receives US FDA feedback on IND submission for use of PPS for knee OA
The company is confident it will soon be undertaking its phase 3 PPS clinical trial in US osteoarthritis patients.
Paradigm Biopharmaceuticals granted Australian ethics approval for pivotal Phase 3 clinical trial in participants with knee OA
“We are pleased to report that preparations to commence our Phase 3 clinical trial are progressing whilst we await the US FDA’s response, expected at the end of September,” says CEO.
Paradigm Biopharmaceuticals has study supporting arthritic disease modifying effects of PPS in chikungunya virus published in peer-reviewed journal
“These critical findings provide confidence in PPS as a potential world-first CHIKV therapy,” said Dr Lara Herrero.
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Paradigm Biopharmaceuticals prepares for “pivotal” phase three clinical trial over FY21
“The achievements of FY21 are important in our journey as a company and help set a strong foundation for Paradigm to grow,” says interim chair and CEO.
Paradigm Biopharmaceuticals' busy June quarter leads to several new avenues
Zilosul® was made available during the second quarter to physicians with SAS approval to treat patients experiencing chronic arthralgia from Ross River virus (RRV) infection.
Paradigm Biopharmaceuticals receives written feedback from FDA relating to IND submission
Pentosan polysulfate sodium (PPS) is currently being evaluated by Paradigm for potential registration for the treatment of osteoarthritis and other inflammatory diseases in the US and other major global markets.
Paradigm Biopharmaceuticals halted as it reviews response from Food & Drug Administration
Securities will remain halted until Tuesday, August 3, 2021, or when an announcement is released to the market.
Paradigm Biopharmaceuticals submits responses to US FDA questions regarding Investigational New Drug application
The late-stage drug development company has a mission to develop and commercialise Pentosan Polysulfate Sodium for the treatment of pain associated with musculoskeletal disorders.
Paradigm Biopharmaceuticals secures approvals for Phase 2 clinical trial treating MPS-VI subjects in Brazil with PPS
This will be the largest clinical trial conducted using PPS in any MPS type subjects, and will evaluate the safety and tolerability of the drug as well as its effects on mobility, urinary GAG levels, walking-related pain, quality of life an
Paradigm Biopharmaceuticals receives US FDA feedback on IND application for PPS in knee OA
The company is on track to respond to questions from the US Food and Drug Administration around its Investigational New Drug application within 30 days.
Paradigm Biopharmaceuticals achieves first revenue via Zilosul® prescription under the TGA Special Access Scheme
Under the pay-for-use SAS program, Paradigm has already received five prescriptions for Zilosul® from physicians and the five patients will commence Zilosul® treatment in the coming week.
Paradigm Biopharmaceuticals progresses IND application with US FDA for knee OA treatment
The FDA was unable to provide all questions within the initial IND review period and has advised it will submit further questions to Paradigm within the next 30 days.
Paradigm Biopharmaceuticals doses first participant in Para_OA_008 clinical trial exploring knee OA synovial biomarkers
The study will investigate changes in knee synovial fluid biomarkers associated with pain, inflammation and disease progression of knee Osteoarthritis.
Paradigm Biopharmaceuticals in new collaboration with bene pharmaChem to co-fund new projects to unlock potential of injectable PPS
Under the new agreement, both parties have agreed to jointly fund the R&D and work collaboratively on new Intellectual Property creation, which Paradigm will commercialise.
Paradigm Biopharmaceuticals submits Investigational New Drug application to US FDA for planned Pivotal study
Once the IND is ‘open’, the company can begin recruitment and screening of participants for the Pivotal Para_002 clinical study – subject to institutional ethics committee approvals.
Paradigm Biopharmaceuticals' Phase 2A Ross River Virus clinical trial results peer-reviewed and published online in BMC Musculoskeletal Disorders journal
The data produced in the pilot study provide clinical evidence that PPS may offer patients a treatment option for a disease that has little or no therapeutic options for chronic RRV infection.
Paradigm Biopharmaceuticals boosts finances with $3.38 million R&D tax refund from Australian Government
Paradigm is a late-stage drug development company with the mission to develop and commercialise Pentosan Polysulfate Sodium for the treatment of pain associated with musculoskeletal disorders driven by injury and inflammation.
Paradigm Biopharmaceuticals receives ethics approval for Phase 2 clinical trial of PPS in knee osteoarthritis pain
The Phase 2 study will evaluate the treatment effect of Pentosan Polysulfate Sodium (PPS) (Zilosul®) compared with placebo on synovial fluid biomarkers in participants with knee osteoarthritis pain.
Paradigm Biopharmaceuticals appoints new non-executive director to support commercialisation plans
The company continues to progress toward submission of the investigational new drug for Zilosul® and is focused on implementation of the osteoarthritis clinical program to support commercialisation.
Paradigm Biopharmaceuticals' additional data on Zilosul® patients under the TGA SAS shows very consistent reduction in pain of nearly 50%
In the 89 patients treated with Zilosul®, 75.3% reported at least a 25% reduction in WOMAC pain with 56.2% of patients reporting a greater than 50% reduction, while in subjects with knee OA, it shows a very consistent reduction in pain of n
Paradigm Biopharmaceuticals moves ahead with PARA_OA_002 clinical trial
Paradigm will be focused on Phase 3 trials of its drug Zilosul® during 2021, COO Jeannie Joughin told Proactive.
Paradigm Biopharmaceuticals to present at the annual JP Morgan healthcare conference next week
The company is focused on the development of a Phase 3 clinical program for its Zilosul® treatment for osteoarthritis.
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Paradigm Biopharmaceuticals proceeding with IND submission for Zilosul® for osteoarthritis after positive FDA Type C meeting feedback
The same clinical trial protocol will be used in the US, Europe and Australia, potentially enabling registrations in multiple jurisdictions, saving time and money.
Paradigm Biopharmaceuticals adds IP expertise to board with Amos Meltzer appointed non-executive director
The company is continuing the search for a person with extensive financial experience who will also be added to the board as an independent non-executive director.
Paradigm Biopharmaceuticals to host first R&D presentation this month to update on Zilosul pipeline
The late-stage drug development company said the presentation would cover its proposed clinical program, safety and an update on other indications in the company’s R&D pipeline.
Paradigm Biopharmaceuticals initiates Mucopolysaccharidosis type I open label Phase II clinical trial with first patient dosed
The trial will be Paradigm’s first in MPS-I patients and will investigate treatment in a population, including pediatric patients.
Paradigm Biopharmaceuticals adds three new senior executives to its team
Commercial head Beverley Huttmann, chief financial officer Justin Cahill and R&D scientist Catherine Stapledon bring skills and experience that further strengthen the capabilities of management as the company moves toward commercialisation.
Paradigm Biopharmaceuticals data shows Zilosul reduces pain in patients with knee osteoarthritis
Pain reduction in 76 SAS patients (42 new patient data) being treated using the Phase 3 product are consistent with prior reports under TGA SAS.
Paradigm Biopharmaceuticals extends exclusive supply agreement with bene pharmaChem
The exclusive supply of Pentosan Polysulphate Sodium for 25 years following marketing approval provides a greater level of commercial protection for Paradigm as it progresses towards commercialisation of Zilosul® in Europe.
Paradigm Biopharmaceuticals has clear path towards Zilosul® OA Phase 3 clinical trial and product registration in Europe
Positive feedback has been received from European Medicines Agency after Paradigm’s recent Scientific Advice meeting, a key regulatory milestone which supports and validates the company’s clinical development and commercialisation plans for
Paradigm Biopharmaceuticals receives critical approvals and feedback from agencies to progress MPS
Paradigm’s investigation of PPS for MPS seeks to establish whether PPS may be an effective adjunct/combination therapy with current Enzyme Replacement Therapy treatments.
Paradigm Biopharmaceuticals higher on reporting 65% pain reduction in OA patients treated under US FDA EAP
Each Patient enrolled in the program was screened to measure their baseline pain scores under the WOMAC osteoarthritis index and evaluated with MRI scans.
Paradigm Biopharmaceuticals set to release results of FDA’s IND expanded access program for Zilosul osteoarthritis treatment
The company remains focused on its IND submission to the FDA for the remainder of 2020.
Paradigm Biopharmaceuticals adds medical and strategic experience to board with executive director appointment
Dr Donna Skerrett has more than 30 years in the pharmaceutical industry and has been the company's chief medical officer since September 2019.
Paradigm Biopharmaceuticals chairman tenders resignation
Paradigm is an Australian biopharmaceutical company focused on repurposing the drug pentosan polysulphate sodium (PPS) for the treatment of inflammation.
Paradigm Biopharmaceuticals strengthens team with additional clinical and commercial expertise
The company is preparing for phase-3 trials in both Osteoarthritis (OA) and Mucopolysaccharidosis (MPS).
Paradigm Biopharmaceuticals share register continues to globalise with upcoming catalysts
The company recently reported a 45% reduction in pain across 34 patients with knee osteoarthritis (OA) using its phase 3 clinical trial product Zilosul.
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Paradigm Biopharmaceuticals completes Zilosul dosing under FDA’s Expanded Access Program
Earlier this month, Paradigm reported a 45% mean reduction in pain score across 34 patients with knee osteoarthritis (OA) using Zilosul.
Paradigm Biopharmaceuticals has significant clarity on development pathway for Zilusol: Bell Potter
The recent market announcements and $35 million capital raise have provided significant clarity to numerous aspects of the company’s development pathway for Zilusol.
Paradigm Biopharmaceuticals completes $35 million capital raising
The company aims to develop and commercialise its safe and effective treatment for sufferers of osteoarthritis.
Paradigm Biopharmaceuticals confirms knee osteoarthritis pain reduction ahead of phase 3 clinical trial of Zilosul
Zilosul was successful in reducing knee osteoarthritis pain score by 45%.
Paradigm Biopharmaceuticals in halt pending response to Food & Drug Administration update
The halt will remain in place until Monday, April 6, or until an announcement is released to the market.
Paradigm Biopharmaceuticals commences Zilosul® treatment for expanded access program
10 Patients are being treated for knee osteoarthritis using the trademarked injectable pentosan polysulphate sodium drug Zilosul®.
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Paradigm Biopharmaceuticals meets with US Food and Drug Administration to discuss development of flagship drug Zilosul®
The biotechnology company is undergoing regulatory processes in Australia, the US and Europe for its injectable Pentosan Polysulfate Sodium (iPPS) drug.
Paradigm Biopharmaceuticals treats first US patient with Zilosul®
Paradigm will treat 10 patients in the US comprised of ex-NFL players with its development drug Zilosul®.
Paradigm Biopharmaceuticals presents patient-centric research at World MPS Symposium
The company is focused on repurposing the injectable drug pentosan polysulphate sodium to treat inflammation in MPS VI patients.
Paradigm Biopharmaceuticals provides market update
Paradigm will be meeting with the US FDA in Feb 2020 for a pre-IND meeting among other things.
Paradigm Biopharmaceuticals’ board member buys $300,000 worth of shares
Paradigm is repurposing the drug Pentosan Polysulfate Sodium (PPS) under the name ZILOSUL®.
Paradigm Biopharmaceuticals’ Paul Rennie adds over $500,000 stock to holding
Paradigm is repurposing the drug Pentosan Polysulfate Sodium (PPS) under the name ZILOSUL®.
Paradigm Biopharmaceuticals targets 2019-20 milestones for OA-MPS-BMEL pipeline
The biotech gained up to 5% by lunch on confirming FY20 milestones, including an early-2020 filing with the US FDA for an OA drug.
Paradigm Biopharmaceuticals shares get a boost following IRB approval to treat ex NFL players
The IRB has followed the FDA in approving the submission to treat 10 ex NFL players with Paradigm’s trial drug Zilosul.
Paradigm Biopharmaceuticals journal publication confirms discovery, shares surge
The company’s data has been published in the peer-reviewed international scientific journal PLoS One
Paradigm Biopharmaceuticals gets FDA clearance for investigational new drug application
FDA Clearance means validation of Paradigm’s safety data, the finished product’s quality and confirmation of an unmet medical need.
Paradigm Biopharmaceuticals makes new breakthrough for iPPS, shares rise
New clinical trial data shows that its trial drug Zilosul (iPPS) also reduces knee cartilage degradation.
Paradigm Biopharmaceuticals files Investigational New Drug submission for ZilosulÒ with FDA
ZilosulÒ (iPPS) is a potential first-line therapeutic treatment for osteoarthritis and other diseases affecting the musculoskeletal system.
Paradigm Biopharmaceuticals director acquires 140,000 shares valued at almost $170,000
Non-executive director Chris Fullerton participated in a $26.3 million entitlement offer and has also purchased shares on-market.
Paradigm Biopharmaceuticals CEO shows faith in company with $49,000 on-market purchase
To facilitate its ongoing development and growth, the company signed employment agreements with five new staff members in late June.
Paradigm Biopharmaceuticals Ltd fully funded as it advances iPPS development
The company is focused on creating commercial opportunities that will generate potential revenue from early sales of finished product or through partnering/commercial transactions.