Health Check: Oncosil hits its goals in key pancreatic cancer trial  

•  Oncosil will accelerate the rollout of its targeted radiation device after promising trial results
• Imricor completes ‘human factor’ ablation catheter study
• PYC’s CEO departure is “disappointing”, opines broker

The developer of a targeted radiation pancreatic treatment, OncoSil Medical (ASX:OSL) says a phase I/II study has proved its eponymous device to be “safe and feasible to deliver” percutaneously.

Amsterdam’s University Medical Centre (UMC) carried out the 20-patient, investigator-led study, dubbed Pancosil.

The study was the first to administer Oncosil – little balls of radiation – via direct injection through the skin. This was with computer tomography (CT) imaging guidance.

To date, clinicians have delivered the treatment endoscopically.

In effect, the trial met its primary endpoints.

The study enrolled locally advanced pancreatic cancer (LAPC) patients, with a median age of 62. Each received a single dose of Oncosil with an active period of 81 days.

Two patients experienced a grade three serious adverse device event – “one possibly device related”.

The trial resulted in 90% technical success rate (feasibility).

The patients survived a median overall 20.6 months, versus the current average survival rate of around 13 months for chemo treatment alone.

Three patients (15%) showed a partial response (tumour reduction).

The study also determined that  patients could be conscious during the procedure.

This is crucial commercially because it reduces the length of the procedure and post-operative recovery.

Delivering hope

“These findings strengthen our clinical evidence base and mark another step forward in our mission to transform outcomes for patients with locally advanced pancreatic cancer,” CEO Nigel Lange says.

The deadliest form of cancer, pancreatic tumours usually are detected too late.

Lange said the company was focused on the 30% of pancreatic cancer patients that can’t be operated on. But they don’t yet have metastasised tumours, in which case the only ‘treatment’ is palliative care.

“As with any cancer, surgical resection remains the gold standard,” Lange says.

More than 30 countries already have approved Oncosil, mainly under the European Union banner. The US is yet to do so.

The company will seek a European indication expansion covering its “innovative” percutaneous approach.

Lange adds the company has not abandoned endoscopy delivery, which could be more suitable for some patients.

UMC’s Dr Danielle Vos presented the results at this week’s Cardiovascular and  Interventional Radiological Society of Europe congress, in Barcelona.

Oncosil shares this morning surged 16%.

Imricor probes The Human Factor

Not to be confused with a spy novel by the late and great Graham Greene, The Human Factor refers to the ability of flesh-and-blood people to stuff things up because of innate behavioural limitations.

Eventually ‘bots will take care of that (or introduce their own foibles, more likely).

Medical devices need to be as foolproof as possible, so ‘human factors’ studies are as important as the clinical ones.

In this vein, heart device developer Imricor Medical Systems (ASX:IMR) has completed a human factors study of all of its devices under review by the US Food and Drug Administration (FDA).

“The study is a critical step in the FDA approval process, ensuring that each device can be used safely and effectively by clinicians in real-world settings,” the company says.

The seven-month study covered 23 electrophysiologists and 23 nurses and technologists across US hospitals.

Imricor is seeking FDA approval for its innovative cardiac ablation catheters. These tools will enable these procedures to be done with real-time magnetic resonance imaging, rather than under x-ray fluoroscopy guidance.

European, Saudi Arabian and New Zealand regulators have approved Imricor’s first device, theVision-MR catheter.

“The scale of this study cannot be overstated, having taken our team over a year from planning through execution,” Imricor CEO Steve Wedan says.

PYC investors are unhappy at Rohan goin’

Few individuals can claim a precise monetary worth, but for PYC Therapeutics (ASX:PYC) CEO Dr Rohan Hockings the number is $209 million.

That’s the value of PYC’s market erosion after Hockings yesterday said he would depart the Perth-based drug developer, after seven years at the helm and 15 years with the company.

Pending a CEO search, chairman and 32% shareholder Alan Tribe will fill the position.

“I would like to thank Rohan for his significant contributions to the company and wish him well  in the future,” the chairman said.

Ah! The Tribe has Spoken.

Broker Canaccord dubs Hockings’ pending exit as a “disappointing outcome, especially in light of his instrumental contribution to the development and validation of technology and clinical assets.”

Formerly known as Phylogica, PYC is developing RNA therapies for select genetic diseases.

The company has clinical programs for the rare eye disease retinitis pigmentosa type II, autosomal dominant eye atrophy and polycystic kidney disease.

Rohan’s old man, Perth cardiologist Dr Bernard Hockings invested in Phylogica in 2012 and was on the board between 2014 and 2021.

Some media reports dub Rohan’s departure as abrupt. But given he’s hanging around until November 16, we don’t concur with that descriptor.

Canaccord says while there’s a “degree of near-term certainty” around PYC’s strategy in some areas, the current share price “heavily discounts” the company’s underlying value.

PYC still bears a market cap of a tad over $500 million.

Proteomics’ tests are up to standard

Proteomics International Laboratories (ASX:PIQ) has obtained International Standards Organisation (ISO) status for its clinical testing services.

While hardly a BBQ stopper, obtaining ISO certification – ISO 15189 to be specific – is a crucial milestone in Proteomics’ quest to commercialise its protein-based diagnostics.

The company has commercialised an assay for diabetic kidney disease, and also has tests for endometriosis, esophageal cancer and oxidative stress.

Along with two previous certifications, ISO 15189 “affirms the company’s position as one of the world’s leading laboratories for proteomics and protein-based based testing services.”

Granted by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia, the ISO 15189 seal of approval applies to the company’s Perth-based labs, systems and processes.