• Recce Pharma moves forward to stronger dose in Phase 1/2 trial
  • EMV is bench testing its 2nd Gen ultra-light weight helmet scanner


Recce Pharma moves forward to higher dosage

Synthetic anti-infectives producer, Recce Pharmaceuticals (ASX:RCE), says the Independent Safety Committee has approved next cohort dosing at a faster infusion in its Phase 1/2 UTI/Urosepsis Rapid Infusion Clinical Trial.

The committee has approved the dosing of RECCE 327 (R327) at a faster infusion rate of 15 minutes of 3,000mg via intravenous administration (IV) for the next cohort of patients.

Furthermore, the committee unanimously agreed R327 at an infusion rate of 30 minutes of 3,000mg is safe and well tolerated in male and female subjects.

The next cohort of subjects have now been recruited, with dosing to begin imminently.

Recce says receiving the committee’s go-ahead is a positive indication of R327’s advancement as a broad-spectrum anti-infective across the full spectrum of UTIs (urinary tract infection). UTIs are responsible for about 30% of all sepsis infections, defined as ‘urosepsis’.

Recce explained that antibiotics administered as an intravenous infusion (usually over 30 minutes) have benefits such as savings in nursing time, reduced costs and improved safety.

“This data also reaffirms R327’s potential first-line treatment for patients suffering from life-threatening infections such as urosepsis or sepsis – as the mortality of sepsis increases by 6-8% for every hour that treatment is delayed,” said Recce CEO, James Graham.


EMV bench tests its Gen 2 headset

EMvision Medical Devices (ASX:EMV) says that an advanced 28-antenna prototype of its 2nd Gen ultra-lightweight helmet scanner has been assembled for bench testing.

The Gen 2 headset weighs under 10kg, and was designed for road and air ambulance deployment to the point-of-care via a backpack.

It contains a 28-antenna 3D array which is designed to provide entire brain coverage in a single scan. A silicone membrane, which has been designed as a reusable but replaceable component, provides coupling of the antennas to the head.

EMV says the bench testing will evaluate a range of technical parameters compared to simulations.

An ethics submission for healthy human volunteer testing has been submitted, and is expected to commence in the coming months.

The regulatory strategy for Gen 2 is to leverage Gen 1 as a predicate device to pursue an FDA 510(k) approval.


Source: EMV


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