Arix Bioscience PLC (LON:ARIX) said its portfolio firm, Pharmaxis Ltd (ASX:PXS), has reported that PXS-5505, its treatment for myelofibrosis (MF) bone marrow cancer, is “well tolerated with no safety signals” in a Phase 1b clinical study.
In its announcement, Pharmaxis said the trial had demonstrated that the drug “effectively inhibits all enzymes in the lysyl oxidase family that are involved in fibrosis” and that the pre-clinical program, regulatory advice and opinions from leading clinicians supported progression into a Phase 2 study.
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MF is a cancer with poor prognosis and limited therapeutic options such as stem cell transplants, for which only a small number of patients are eligible, or administration of a JAK1/2 inhibitor which provides symptomatic relief but carries a risk of worsening blood cell counts.
“With the successful completion of the Phase 1b study, 6-month toxicity studies, 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”, Pharmaxis chief executive Gary Phillips said in its statement.
“We have ongoing discussions with contract research organisations who are confident of a trial recruitment start by the end of the year despite the impact of [coronavirus] on clinical trials worldwide. A number of contingency plans to maintain this timeline are actively being explored”, he added.
Pharmaxis said it will provide an update on the Phase 2 trial once it receives final regulatory clearance in the third quarter of 2020.
Shares in Arix were up 2.3% at 84.4p in early trading on Tuesday.