An Australian biotech is trying to fight cancer from the inside by implanting a tiny device directly into tumours with a needle to irradiate them.

OncoSil Medical (ASX:OSL) — which was last week named one of the next likely takeover targets amid a boom in Australian Life Sciences — has so far trialled its device in pancreatic and liver cancer patients, but hopes it may one day be used to fight a wider range of indications.

“The device is made with microparticles that are a combination of silica and phosphorous, which is radioactive,” OncoSil boss Daniel Kenny told Stockhead.

Once the microparticles are injected, they stay inside the tumour and give off radiation for about 90 days.

“Eventually you’re left with silica and sulfur* in the tumour — but it’s not radioactive. The sulfur also attacks the tumour,” Mr Kenny said.

“It’s a technology platform that could theoretically be used in any solid tumour.”

Blood vs needle

OncoSil’s approach to fighting cancer follows in the footsteps of Sirtex (ASX:SRT), which makes what it calls “SIR-Spheres” that also attacks tumours.

However Mr Kenny said those were delivered via the bloodstream rather than implanted directly into the tumour.

“We use ultrasound-guided endoscopy to target the pancreatic tumour, then we use a needle to implant the microparticles,” he said.

“It’s a similar principle, but different delivery mechanism.”

OncoSil had completed feasibility and preclinical studies to show the idea was sound, and was now conducting further studies with the hope of take the device to market.

“In our earlier pancreatic studies, we’ve had target tumour responses rates greater than 20 per cent and disease control rates greater than 80 per cent,” he said.

The company is planning to treat up to 40 patients in total in the current studies involving up to 15 centres globally.

By the end of December 33 patients had been enrolled in the study and 27 had been implanted with the OncoSil device — which should be enough to satisfy requirements for a European Union tick of approval.

Last month OncoSil reported continuing trial data showing “outstanding local disease control and tumour volumetric reduction when the OncoSil device is used with concomitant standard of care chemotherapy”.

European certification

If the current studies proved successful, OncoSil would seek approval to use the device in Europe before Australia.

“Early in 2017, the European Notified Body confirmed to us we would be granted the CE mark once we provided supplemental data on an extra 20 patients showing consistently safe results,” Mr Kenny said.

The CE mark is an approval that a device conforms to European health and safety standards, similar to a tick from the Therapeutics Goods Administration (TGA) in Australia or the Food and Drug Administration (FDA) in the US.

OncaSil is now aiming to submit data for its first 20 patients to the EU by May 31.

“We believe that in the coming months we will secure a CE Mark and the device will be used as an adjunct in the first-line setting in combination with chemotherapy,” Mr Kenny said.

OncoSil Medical shares (ASX: OSL) over the past year.
OncoSil Medical shares (ASX:OSL) over the past year.

If OncoSil does receive a CE mark, it will then submit for similar approval in Australia.

However Mr Kenny said getting a device approved and onto the market was only the first step.

“It means moving from the trial phase into commercialisation,” he said. “Our job would then be to continue clinical development and trials to look at other indications for the device.”

OncoSil burned through $2.8 million in the December half, leaving $5.1 million in the kitty plus a $600,000 tax refund received in January.

The shares doubled from 9c to 18c between September and December after initial reports of progress in the trial recruitment phase.

They closed at 14c on Monday.


* Sulphur or sulfur? Traditionally it was ‘sulphur’ in British English and ‘sulfer’ in American English. But as Nature pointed out in 2009, the International Union of Pure and Applied Chemistry settled any argument, declaring the international scientific spelling as ‘sulfur’. Now you know.