Paradigm Biopharmaceuticals (ASX:PAR) has received ethics approval for its Phase 2 clinical trial of the drug pentosan polysulfate sodium (PPS) for the treatment of Ross River virus.
The ethics approval means the Phase 2 clinical trial can commence with first participant dosing expected in the coming weeks in Brisbane, Queensland.
Paul Rennie, CEO, commented: “Currently, there is no effective way to treat patients with Ross River virus.
“While the joint pain it causes can be managed, current therapeutics have not been shown to treat the detrimental effects on joint cartilage that are associated with the disease.
“Given that PPS has an established clinical safety and tolerability profile and positive Ross River pre-clinical data, we hope PPS can also prove successful in this Phase 2 trial.”
Clinical trial details
The Brisbane clinical trial will be run by Dr Paul Griffin at Mater Research, Paradigm’s clinical research partner.
Ethics approval for its Geelong, Victoria clinical trial site is also anticipated in the coming weeks.
The randomised, double-blinded placebo-controlled clinical trial will treat a total of 24 subjects across both trial sites.
Patients with Ross River induced arthralgia (painful joints) will be evaluated for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections, with results anticipated in mid-2018.
Analysis
The ethics approval and consequent commencement of the Ross River trial continues Paradigm’s strong momentum making this the company’s fourth active clinical trial.
Paradigm’s share price is up 65% in 2017 to $0.65.
The Ross River virus affects hundreds of thousands of people in South Asia each year and there is currently no effective treatment for either disease.
During February, two brokers covering Paradigm updated their recommendation and price targets.
Baker Young has a Buy Recommendation on the stock with a $1.16 per share price target, while DJ Carmichael applying a Speculative Buy and a risked valuation of $1.32 per share.