Melbourne breast cancer trial to test Optiscan imaging device
The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients.
The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices.
Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed.
Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge.
'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.'
Optiscan Imaging chief executive officer and managing director Dr Camile Farah
Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application.
The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification.
While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
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News.com.au
3 hours ago
- News.com.au
ASX Tech June Winners: Defence tech stocks dominate record-breaking month
S&P500 and Nasdaq hit new highs on Big Tech run
 ASX energy leads, but tech holds strong in June
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This, it said, will be fuelled by profit upgrades and the broader shift in investor psychology: that AI and semiconductors aren't just themes, they're foundational to the next economic cycle. And while Wall Street partied, the ASX didn't just sit in the corner holding a warm beer. Energy stocks absolutely belted it in June, up 9% for the month, easily the strongest sector. Blame Middle East supply fears and a tight physical market keeping oil prices jumpy. Monthly return for ASX Sectors But the quiet achiever in June was tech, up 0.73% for the month and moving in rhythm with the global tune. Names like NextDC (ASX:NXT) got some love after recent pullbacks. And Goodman Group (ASX:GMG), with its data-centre exposure, continues to look like a long-term compounder. Local investors are waking up to the fact that some of our home-grown names are quietly building the digital infrastructure of the future. BlackRock is flagging defence tech as the next trend to watch. 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News.com.au
3 hours ago
- News.com.au
Biocurious: Dimerix could be riding big and beautiful kidney drug success earlier than expected
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'In rare diseases, no-one is going to do these studies,' Webster says. About five years ago the FDA became more amenable to the use of 'surrogate' endpoints These are measures that substitute a true clinical endpoint to expedite drug development. The FDA allowed the use of the kidney function biomarker, called estimated global filtration rate (eGFR). Under the dainty banner of 'Parasol' – and, no it's not an umbrella group – experts advised the use of proteinuria as a further alternative endpoint for FSGS. Proteinuria is kidney proteins seeping into the urine, while eGFR is the rate at which the spuds can cleanse blood. If proteinuria is present and the eGFR is not up to scratch, they are sure signs the kidneys are not working as they should. Conversely, if a drug reduces proteinuria or the eGFR 'slope rate' – the rate of decline – it is accepted as being effective. Parasol promises faster Action Dubbed Action 3, the Dimerix trial involves two years' treatment, as measured against placebo. The study is due to complete in 2027 when the last patients have been treated. But Dimerix now is working with Parasol to establish the exact surrogate endpoints required to front the FDA for accelerated marketing approval. Expedited approval is as allowed for some orphan drugs, such as DMX-200. 'The full study is for two years and that doesn't change,' Webster says. 'Th question is whether we can get interim approval and go to market earlier.' One possibility is that proteinuria alone could be the accepted endpoint, given proteinuria and eGFR appear to point to the same thing. That is: deteriorating kidneys. Dr Webster says an accelerated endpoint must reasonably predict the outcome of the trial. 'The question is, what do we need to see at point X to prove the end at point Y? Parasol is working with us on that. 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'These patients currently have limited treatment options and Filspari looks like it is doing something for them. 'We are waiting with bated breath in the hope that Filspari is approved and gives hope to these patients.' Travere has licensed the European and local sparsentan rights to our own CSL (ASX:CSL). … but we're friends, not rivals Webster says rather than rivalling DMX-200, sparsentan could be used in unison. An angiotensin receptor, sparsentan targets high blood pressure – a key cause of kidney disease in the first place. (High blood pressure causes inflammation which causes scarring and cell death). Thus, sparsentan needs to be better than the current blood pressure medication. But DMX-200 works on the secondary inflammatory pathway, with the patients already on blood pressure meds. 'It's not apples for apples with study design, which is why we are compared against the placebo and not a comparator,' Webster says. In effect, DMX-200 faces a lower comparative hurdle. 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'That was a big moment for us, because we wanted to confirm something similar to our smaller phase II study in a larger cohort of patients.' FDA approval could come sooner rather than later Dimerix has received over $65 million of cash, courtesy of four distribution deals that may deliver up to $1.4 billion of milestone payments plus royalties. While a further capital raising is a case of 'never say never', it's unlikely. Naturally, most of the milestones are back ended to achievements such as phase III success and FDA approval. But with accelerated approval possible after the interim analysis, the latter might be sooner than investors think. Many drug developers view the Trump Ascendancy Mark Two with trepidation. In contrast, Webster notes Trump nominated kidney disease as a key health priority in his first stab at POTUS. The financial motive alone is compelling, in that dialysis costs the US health system around US$125 billion annually. 'We are in the sweet spot of being a rare disease (with pricing benefits) and having the potential to reduce US healthcare costs,' Webster says.
AU Financial Review
5 hours ago
- AU Financial Review
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