Recently purchased a smallish parcel (RL) in this high risk/reward biotec for interest sake as the potential appears significant. Todays announcement (see extract below) provides some confidence that OSL could be doorstepping a re-rate however still a long way to go however 22/23 should determine their success or otherwise.

ASX Announcement 3 February 2022:

OncoSil approved for Innovation Funding (NUB) and Central Ethics for all hospitals in Germany:

Key Highlights:

The Institute for the Hospital Remuneration System (InEK) has granted the OncoSil device with a “Positive Status 1” classification

25 leading university hospital sites in Germany submitted requests for innovation funding (NUB) for the OncoSil device

Hospitals which submitted NUB applications can now individually negotiate with Statutory Health Insurance providers (“Sickness Funds”) for reimbursement of the OncoSilTM device for patient treatments; and further

The University of Cologne Hospital ethics committee has approved the OSPREY Registry, acting as central ethics approval for all hospital sites within Germany. 

I've been watching these guy's ever since SIRTEX was taken over. Reading through their other announcements it seems they're now finally closing in on a full global release.

Time for me to pick up a smallish starting position in what must be regarded as high risk.

ASX Announcement 24 December 2021

PanCO Clinical Study on OncoSil™ Published in ESMO Open International, Multi-Centre Study shows Encouraging Safety and Efficacy Results for OncoSil™

Added to Standard-of-Care Chemotherapy for Patients with Unresectable Locally Advanced Pancreatic Cancer Key Highlights

Addition of OncoSil™ radioactive microparticles to standard-of-care chemotherapy is safe and effective;

Local disease control at 16 weeks achieved in 90.5% of the patients treated; and

23.8% of patients proceeded to surgical resection with curative intent. Sydney, Australia – 24 December 2021:

OncoSil Medical Ltd (ASX: OSL) (OncoSil or the Company) is pleased to announce the publication of the final results of the PanCO clinical study.

The results demonstrate the safety and efficacy benefits of the OncoSilTM device in combination with standardof-care chemotherapy for the treatment of patients with unresectable locally advanced pancreatic cancer (LAPC).

The full paper is published in ESMO Open, the European Society for Medical Oncology's peer-reviewed open-access journal dedicated to publishing high-quality medical research.

PanCO was an international, multi-centre, single-arm, prospective clinical study of intra-tumoral OncoSil™ phosphorus-32 microparticles for unresectable LAPC.

It was conducted at 10 specialist centres in Australia, Belgium and the United Kingdom.

The primary endpoint of the PanCO study was safety and tolerability, and the results demonstrated that OncoSil™ had an acceptable safety profile when added to standard-of-care chemotherapy comprising either gemcitabine plus nab-paclitaxel or FOLFIRINOX, the two most widely used regimens for treating patients with advanced pancreatic cancer.

No radiation-related serious Adverse Events (AEs) were reported in the PanCO study and there was no evidence that the incidence of severe AEs changed after OncoSil™ implantation.

The main efficacy endpoint of the PanCO study was the proportion of participants with local disease control at 16 weeks, which was achieved in 90.5% of the patients.

This met the pre-defined criteria for statistical significance (p<0.0001). In thirteen (31.0%) of the PanCO study participants who received OncoSil™, partial responses to treatment were demonstrated with a disease control rate of 100% as the best response.

Although the study recruited patients whose cancers were defined as unresectable by highly experienced pancreatic cancer experts, nearly one-in-four of the PanCO study participants (10 of 42; 23.8%) proceeded to surgical resection with curative intent following treatment with chemotherapy plus OncoSil™

Furthermore, there were additional patients who received chemotherapy plus OncoSil™ who also became technically resectable, but they did not proceed to surgery for medical reasons or patient choice.