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.
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 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.