• Argenica is progressing rapidly in the Phase 1 clinical trial of ARG-007
  • Inoviq streamlines its US commercial rollout
  • Medlab’s NanaBis (NanaDol) approved in the UK


Argenica moves to a higher dose cohort

Argenica Therapeutics (ASX:AGN) surged as high as  9% this morning after announcing that the first patients in the third cohort of its Phase 1 clinical trial of ARG-007 have been dosed.

The subjects in this cohort will receive a higher dose of ARG-007 than the second cohort.

Data analysed so far showed no clinically relevant changes across all assessments.

Importantly, the dosed patients in the sentinel group showed no serious safety issues 24 hours after dosing, and therefore dosing of the remaining participants in Cohort 3 will now be completed over the next few days.

Following the dosing of these patients,  data will be presented to the Safety Review Committee which will then confirm the progress of the trial to the fourth and final cohort.

“This is good news, and the trial is progressing extremely well. All participants dosed to date have shown good safety and tolerability profiles,” said Argenica CEO, Dr Liz Dallimore.

Dr Dallimore says the data gives Argenica the confidence to look forward to the Phase 2 trial.

“This is a really exciting stage for the company, and we look forward to continuing to progress the clinical development of ARG-007.”

ARG-007 is Argenica’s lead candidate. It’s a neuroprotective peptide developed by researchers at the Perron Institute and The University of Western Australia (UWA).

The drug was developed as a novel therapeutic to reduce brain tissue death after stroke, with the potential to enhance recovery once a stroke has taken place.


Inoviq preps for US market entry

Inoviq (ASX:IIQ) provided investors with a commercial update this morning.

The company says the commercial rollout of EXO-NET in the US is delivering strong customer interest following a campaign by the sales team.

Additionally, the research, development and manufacture of EXO-NET  has now been centralised to Inoviq’s upgraded Australian facility in Melbourne.

Inoviq will upgrade the Melbourne laboratory to enable the company to streamline R&D activities and expand production capacity going forward.

Meanwhile, the US distribution of the hTERT ICC test will also be reverting to Inoviq in January 2023.

This will allow the company to make direct sales to customers, increase margin and improve its service to clients.


Medlab gets OK from UK regulator

Medlab Clinical (ASX:MDC) announced that NanaBis (named NanaDol for UK purposes) has been approved by the UK Medicines and Healthcare Product Regulatory Agency (MHRA) for use in the UK Named Patient Program.

NanaDol was designated as an unapproved medicine, and will be provided to UK patients via doctor prescription for pain patients, including cancer bone pain.

Cancer bone pain has been previously identified as an area of focus by Medlab.

WEP Clinical was named as the distribution partner, and will work to help UK patients and physicians gain early access to unregistered medicines as appropriate.

Like the Scheme Access Scheme (SAS) in Australia, UK patients will be charged a “compassionate” price for access to the medicine.

Medlab is now requesting the UK Home Office for the appropriate importation certification needed to physically freight NanaDol.

The product is already manufactured and awaiting shipment for potential January 2023 patient supply.


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