Health Check: Telix edges closer to a radiotherapy for difficult brain cancers 

• Telix says the latest stanza of its glioma study is highly encouraging, while Clarity advances its prostate cancer trial
• Arovella girds for a first-in-human trial, while Neuroscientific shares soar on stem-cell deal
• PainChek prepares to meet with the FDA to discuss its application for US marketing approval

The quest for more effective cancer radiotherapy continues apace, with Telix Pharmaceuticals (ASX:TLX) today reporting “encouraging” preliminary results from its phase II study to treat recurrent high-grade glioma (brain cancer).

Dubbed IPAX-Linz, the eight-patient study “substantiates the patient benefit” seen in a previous study, dubbed IPAX-1.

A single-arm (non-placebo) investigator-led trial, IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of Telix’s therapy, TLX101.

This is in combination with external beam radiation therapy, to patients with first or second recurrence of the disease.

As well as being well tolerated with no serious adverse events, IPAX-Linz showed a median ‘overall survival’ of 12.4 months from treatment initiation, or 32.2 months from initial diagnosis.

This compares with current overall median survival from initial diagnosis of 12-15 months.

“These are encouraging results, offering new options for patients with historically poor outcomes,” says Telix chief medical officer Dr David Cade.

Telix has two approved prostate cancer diagnostics on market and is angling for US Food & Drug Administration (FDA) consent for a kidney cancer diagnostic.

A therapy – as opposed to a diagnostic – would move the dial further.

Clarity on prostate cancer trial

Speaking of which, Clarity Pharmaceuticals (ASX:CU6) yesterday said it had treated the first of 24 intended patients in the expansion cohort of a phase II trial.

The study uses Clarity’s proposed copper isotope based prostate cancer ‘theranostic’ (diagnosis and treatment) candidate.

This follows and earlier trial that cleared the way for increased dosage and upping the number of cycles from four to six.

The participants will receive Clarity’s candidate, with some also administered the receptor pathway inhibitor called enzalutamide.

The trial focuses on patients with metastatic castration-resistant prostate cancer who are yet to receive chemo.

Prostate cancer is the second most common cancer diagnosed and the fifth leading cause of cancer death in men.

Arovella girds for human trial of its novel cell therapy

Arovella Therapeutics (ASX:ALA) notes it has $23.5 million in the bank – enough to support a planned first-in-human trial of its CAR-INKT therapy. In late February the company said it had raised $15 million.

CARs are chimeric antigen receptors.

INKTS are invariant natural killer T cells, which have nothing to do with Oliver Stone’s 1994 appalling splatterfest Natural Born Killers.

Rather, the therapy involves removing rare-ish INKT cells from the blood and enhancing them to improve their cancer-busting abilities.

Arovella is the only ASX-listed entity pursuing such a mechanism of action, and its program is based on developing allogenic (off the shelf) drugs using donor tissue, rather than the patient’s own cells.

Arovella is seeking FDA assent for the phase I trial.

This study will enroll non-Hodgkin’s lymphoma and leukemia patients exhibiting the CD-19 biomarker.

Arovella also has a solid tumour program, for indications including gastric cancer.

Last year, it said it had completed the CAR-INKT manufacturing process – which is no mean feat – and had held a fruitful meeting with the FDA.

The company aims to file its investigation new drug application with the agency by the end of June, with trial kick-off this calendar year.

“The sector is currently facing a very difficult time off the back of political uncertainty,” Arovella chief Dr Michael Baker says.

“However, we continue to make important strides taking ALA-101 into clinic and can continue to develop our programs as planned, which is exceptional.”

Hero stock almost doubles on stem-cell news

Today’s big cell therapy hero, though, is minnow NeuroScientific Biopharmaceuticals (ASX:NSB), which has acquired a package of stem cell assets from the private WA-based Isopogen.

The tech aims to tackle Crohn’s disease.

To fund the shebang, the company is undergoing a $3.5 million placement at 3.5 cents a share.

Neuroscientific shares this morning soared from 3.5 cents to as much as 6.9 cents, but the company’s market cap still is not much more than its post-placement cash ($7.5 million).

The company notes the FDA’s recent approval of Mesoblast’s stem cell drug for graft-versus-host-disease has piqued interest in the sector.

No pain, no gain as Painchek fronts the FDA

Developer of the world’s first smart device-based pain assessment and monitoring device, PainChek (ASX:PCK) also is due to meet with the FDA this month to discuss its application for US marketing approval.

The company lodged the application last November, under the new device route.

The agency has asked for “additional information for clarification” and the chinwag is intended to sort out the issues.

Amid the staffing mayhem afflicting the FDA, Painchek notes the review process is led by the same FDA exec the company engaged with in 2019.

“This continuity and constructive engagement provides added confidence that Painchek is well positioned to become the first and only FDA-regulated pain assessment app available in the US market,” the company says.

Painchek is used in nursing homes, where many residents are unable to enunciate pain because of dementia or other reasons.

The company already has an extensive foothold in the local market and – to a lesser – degree the UK.

But the US presents the biggest market, with a US$100-million-a-year aged care opportunity.

Painchek expects FDA clearance by June.

In the meantime, the company has launched a variant for pre-verbal infants on the Apple App Store.

The company plans a broader rolled out in the June quarter.

Tariffs ‘no problema’ says Austco after winning spicy Mexican deal

Formerly Azure Healthcare, Austco Healthcare (ASX:AHC) has won a $3.4 million contract to supply Mexico’s Angeles Health System with its nurse call platform and infant protection systems across three of its flagship hospitals.

The multi-year agreement enhances Austco’s presence in the Latin American healthcare market and involves designing and installing the systems, as well as offering long term support to the client hospitals.

Austco expects the revenue to start to flow in this financial year and continue to the 2028-29 year.

But what about the ‘T’ word?

No problema, says the company – the goods won’t touch Americano shores.

“Austco’s drop-shipping model enables direct shipments to Mexico, bypassing tariff-impacted routes and ensuring cost predictability and uninterrupted delivery.”