Arix Bioscience’s (GBX:ARIX) portfolio firm, Pharmaxis (ASX:PXS), said that a clinical study has shown that its treatment for myelofibrosis bone marrow cancer is ‘well tolerated with no safety signals.’
Pharmaxis reported that the phase 1b trial for PXS-5505 had demonstrated that the drug ‘effectively inhibits all enzymes in the lysyl oxidase family that are involved in fibrosis.’
The pre-clinical program, regulatory advice and opinions from leading clinicians now supports progression into a phase 2 study of the rare bone cancer which carries a high unmet need.
Myelofibrosis, which has a poor prognosis and limited therapeutic options, is an uncommon type of bone marrow cancer that disrupts your body's normal production of blood cells.
A stem cell transplant is only possible in a small number of patients whilst administering a JAK1/2 inhibitor can provide symptomatic relief but carries a risk of worsening blood cell counts.
Shares in Arix Bioscience were trading 1.21% higher at 83.5p during Tuesday morning.
Gary Phillips, CEO of Pharmaxis, noted the successful completion of the phase 1b study and 6‐month toxicity studies as well as support from clinical key opinion leaders and preliminary regulatory feedback.
“We can now move confidently into a 6‐month phase 2 study in myelofibrosis with meaningful clinical efficacy and safety endpoints,” he said.
He added that contract research organisations were confident of a trial recruitment start for the group by the end of the year despite the impact of Covid‐19 on clinical trials worldwide.
He said, “A number of contingency plans to maintain this timeline are actively being explored.”
The company said it will provide an update on phase 2 trial design once it has received final regulatory clearance in the third quarter of 2020.
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