Polarean upbeat on results of pilot study

The AIM-traded firm said it has received ‘Notice of Allowance’ on the latest US Patent Application 15/120,013, titled "Hyperpolarized Noble Gas Production Systems with Nanocluster Suppression, Detection, and/or Filtering and Related Methods and Devices", to which it had exclusive rights.

It said the patent, together with its knowledge, had led to increasing levels of polarisation for its gas-hyperpolarisation platform for MRI.

That was reportedly “key” to advancing image quality, exploring new applications and increasing the overall efficiency of the company's polarisers.

Polarean also reported completion of the pilot study prior to Phase III clinical trials, reporting that in anticipation of its phase III Trials comparing hyperpolarised 129-Xenon gas MRI to 133Xe scintigraphy - a widely-used imaging technique - it commissioned a pilot study at one of its trial sites.

The pilot study was conducted to validate the study design and the proposed analysis methods of the phase III Trials, along with the proposed analytical methods that would be used in the trials.

“The pilot study enrolled ten COPD patients across a range of disease severity,” the Polarean board explained.

“Each patient underwent scanning by both 129Xe MRI and 133Xe scintigraphy.

“COPD patients were selected for the pilot study due to their expected similarity to the patients that will participate in the phase III Trials and the relative ease of their recruitment.”

Polarean said all scanning protocols were identical to those that would be used in the phase III trials.

It said the scans for each modality were quantified by a standard six-zone analysis to calculate the percentage of lung function contributed by each of the six lung zones, as well as the total right lung function.

“This pilot study of 10 patients, which is representative of population for the phase III trials, gives the company confidence in its trial design.”

Polarean said that meant the chosen methodology was appropriate, and should maximise the probability that both the primary and secondary endpoints of the phase III Trials would accurately reflect the comparative values of 129Xe MRI versus 133Xe scintigraphy.

It said its phase III clinical trials were now scheduled to start in mid-August.

They are 'head-to-head' non-inferiority trials versus 133Xe scintigraphy, with the aim to pursue a “structural claim” for the use of its product as a contrast agent.

The phase III trials would evaluate two patient populations - candidate patients for lung lobe resection and lung transplant procedures - and would total 80 patients in aggregate.

In those populations, lung function information would be obtained and non-inferiority against 133Xe scintigraphy would be compared.

Polarean said it currently expected data collection for the phase III trials to complete during the third quarter of 2019, and if the trials are successful, it aimed to submit its new drug application with the same claim as the approved comparator 133Xe drug, "for the evaluation of pulmonary function, for imaging the lungs", shortly thereafter.

“Polarean is a drug-device company and will undertake 'head to head' non-inferiority clinical trials,” said chief executive officer Richard Hullihen.

“We took the opportunity to reduce the risk in our pivotal trials by commissioning the pilot study to directly test the workflow and analytical and measurement methodology of our trials on 10 patients which comprise 25% of each indication’s trial population.

“We are pleased with the results of the pilot study and look forward to providing further updates regarding the Phase III Trials as appropriate.”