• Pharmaxis gets ~$5m to collaborate on a Phase 2 study of lead drug, PXS‐4728.
  • Imugene escalates to the next dosage in Phase 1 trial

Leading charity, Parkinson’s UK, will provide £2.9m (~$5m) to fund a Phase 2 study of the Pharmaxis (ASX:PXS) drug, PXS‐4728.

Working in a groundbreaking collaboration, leading neurologists from the University of Sydney and the University of Oxford will recruit 40 patients with iRBD (isolated Rapid Eye Movement Sleep Behaviour Disorder) to participate in a placebo‐controlled Phase 2 trial.

Previous research has identified that the development of isolated iRBD, where otherwise healthy people start acting out their dreams, is the strongest predictor for the development of Parkinson’s disease and dementia with Lewy Bodies.

A recent multicentre study found that over 70% of iRBD patients transitioned to a neurodegenerative disease.

The study will examine whether targeting inflammation in the brain of people with iRBD might provide a viable neuroprotective strategy to prevent the disease.

Arthur Roach, Director of Research, Parkinson’s UK, said, “Parkinson’s is the fastest growing neurological condition in the world, and currently there is no cure.”

“Current therapies only help to manage symptoms, so there is an urgent important need for new and better treatments that can slow the devastating progression of the condition.”

PXS‐4728 is an inhibitor of the inflammatory enzyme SSAO (semicarbazide‐sensitive amine oxidase) that was discovered by the Pharmaxis research team.

The drug was licensed in 2015 by Boehringer Ingelheim, and has been extensively studied in 11 clinical trials including the inflammatory diseases of NASH and diabetic retinopathy.

Pharmaxis is currently assessing proposals from a number of contract research organisations to manage the study and expects to commence recruitment in the first half of 2023.


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Imugene escalates dose in Phase 1

Imugene’s (ASX:IMU) Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of cancer-killing virus CF33-hNIS (VAXINIA), has reached key next milestones in the trial.

The intratumoral (IT) cohort 1 has now cleared, which sees the opening of cohort 2 for IT administration, while in parallel intravenous (IV) cohort 1 has also opened.

The Cohort Review Committee (CRC) has unanimously agreed VAXINIA to be safe, with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after reviewing the first three patients’ dose.

Once patients in the monotherapy group have been treated with the lowest doses of VAXINIA and acceptable safety has been demonstrated, new study participants will receive it in combination with the immunotherapy pembrolizumab.

This is expected to begin following cohort 2 being cleared per route of administration.

Overall the study aims to recruit up to 100 patients across approximately 10 trial sites in the US and Australia.


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