• Pharmaxis widens clinical trial following FDA guidance
  • Aroa receives US FDA 510K clearance
  • Cynata gets Australian Ethics approval to commence Phase 2


Pharmaxis to widen Phase 2 trial after FDA feedback

Fibrotic diseases specialist Pharmaxis (ASX:PXS) says it will add a combination treatment arm to the current Phase 2 clinical trial of PXS‐5505 following US FDA feedback.

The clinical trial is studying the effects of lead drug PXS‐5505 on myelofibrosis patients, but will now be widened to include myelofibrosis patients already receiving a JAK inhibitor as standard of care in combination with PXS‐5505.

A JAK inhibitor interferes with signals in the body that are thought to cause inflammation.

The FDA examined safety and efficacy data from Pharmaxis’ Phase 1 monotherapy trial, and has now provided guidance on the number of patients, treatment dosage, study duration and endpoints for a study in combination with a JAK inhibitor.

Following this guidance, Pharmaxis now plans to submit a protocol amendment to global regulators, including the FDA, that will add an arm to the existing myelofibrosis study and utilise its existing trial sites.

Based on the FDA feedback, it is anticipated that the trial design can be streamlined to initiate the combination arm at the same dose currently used in the monotherapy arm and commence later this year.

Pharmaxis CEO, Gary Phillips, said the widened study will maximise the commercial opportunity for PXS‐5505.

“We are already in discussion with the existing trial site investigators who have welcomed the opportunity to extend the patient population for the study and anticipate significantly accelerated recruitment,” said Phillips.

Pharmaxis will provide further details of study design, timelines and costs for the PXS‐5505/JAK Inhibitor combination arm of the MF‐101 study after it receives feedback from regulators on the amended protocol, expected in Q2 this year.


Aroa gets FDA clearance

Aroa Biosurgery (ASX:ARX) has just received US FDA 510K clearance for its Enivo pump and catheter solution.

The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery.

It has been cleared for use in the removal of surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.

Currently, surgeons use surgical drains, adhesives, and quilting sutures to manage dead-space and prevent fluid accumulation, but these techniques have been unreliable.

Following this FDA clearance, Aroa plans to pursue approval for the AROA ECM sleeve, the third component of this system, including a DeNovo application to support use and expand future claims.

“Gaining FDA clearance is a key milestone in establishing our second technology platform,” said Aroa CEO, Brian Ward.

“We expect to develop a portfolio of products based on this technology platform for a range of soft tissue reconstruction procedures.”

The Enivo system complements the AROA ECM, and the company expects that these technology platforms will be synergistic when used concurrently.

According to Aroa, the total addressable market for the Enivo Tissue Apposition Platform in the US is estimated to be in excess of US$1 billion.


Cynata gets Ethics approval

Cell therapeutics specialist Cynata Therapeutics (ASX:CYP) has received approval from the Australian Human Research Ethics Committee (HREC) to commence the proposed Phase 2 clinical trial in acute graft-versus-host disease (aGvHD).

Ethics committee approval is an essential step in the process of commencing a clinical trial in humans at Australian study sites.

This Australian approval follows the landmark clearance by the US FDA of Cynata’s Investigational New Drug (IND) application in 2022, as well as the grant of Orphan Drug Status for CYP-001 and Institutional Review Board (IRB) approval in the US.

“The proposed clinical trial has a strong foundation given the very promising results achieved in our Phase 1 clinical trial of CYP-001 in steroid resistant aGvHD,” said Dr Jolanta Airey, Cynata’s chief medical officer.


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