Today's issue of Bioshares (reputable and independent analysis of Australian biotech companies) featuring OSL.
Oncosil Medical’s Frustrating Progress
Oncosil Medical (OSL: $0.093) is commercialising a therapy, Oncosil, initially for the treatment of pancreatic cancer. Oncosil is a liquid suspension, ultra pure, polysilicon particles bound with radioactive isotope (Phosphorous 32), which is implanted in pan- creatic tumours using an endoscopic ultrasound.
This week the company announced it should be granted a CE Mark (European marketing clearance) once it had provided sup- plemental data to its European Notified Body. The supplemental data will come from 20 locally advanced pancreatic cancer patients. The company has also agreed to a undertake a post marketing follow-up program.
The company does not need to recruit any further patients, since it will be able gather the necessary data from the 20 patients that the FDA has required Oncosil Medical in recruit for a lead-in safety study component of its 300 patient Pivotal Study.
The lead-in component is effectively a pilot study, and is described as such by the company with its study title as registered with clinicaltrials.gov as “A Pilot Study of OncoSil Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane (PanCO)”.
Oncosil Medical’s CEO Daniel Kenny is confident that the company will obtain a CE Mark this calendar year, after obtaining the necessary data by Q3 2017. The company expects to begin recruitment for the pilot trial this quarter. It anticipates filing a PMA application with the FDA around 2020.
A key challenge for Oncosil Medical is funding. As of December 31, 2016 the company retained cash of $13.8 million. The company expects its Oncopac-2 trial to cost between $18 and $20 million. So while the company is in a position to commence its pivotal study, it will need to source funds to complete the trial. However, what will influence its capacity to raise funds is the rate at which it recruits into its 300 patient pivotal study, as well as into the 20 patient pilot study.
The company expects to build out to 30 sites for the 300 patient pivotal study. So far, the company has about 12 sites that have agreed to participate in the study, or are in the process of doing so.
However, the inclusion criteria for the study is for patients with unresectable, locally advanced, pancreatic cancer. This group of patients accounts for about 25% of newly diagnosed pancreatic cancer patients. Thus the pool in Australia of eligible new patients each year would be about 800 (25% of 3,200) and in the US about 13,400 (25% of 53,670).
The administration of Oncosil, a radiotherapy, is more complicated than the current standard-of-care used to treat pancreatic cancer (in the US), gemcitabine and nab-paclitaxel, which are both delivered by IV infusion. This usage difference has the potential to either reduce the patient intake pool or increase the drop-out rate, and partly because Oncosil must be ordered in 28 days in advance of administration.
We iterate our comments from Bioshares 659: “Investors with a longer term outlook may prefer to wait until the company completes the 20 patient safety arm component of its 300 patient trial, with safety confirmed and a sense of how the trial will recruit is established.”
Oncosil is capitalised at $44 million. Bioshares recommendation: Speculative Hold Class C
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