• Imaging specialist Clarity opens patient recruitment in Australia and will start Phase 2 trial soon
  • Another imaging specialist Optiscan has made a FDA Pre-Market Notification 510(k) submission 
  • Recce Pharma says dosing of Cohort 7 of its Phase 1 trial has been completed

Clarity Pharma (ASX:CU6) surged 9% this morning after announcing the opening of recruitment in Australia for its imaging trial of lead product SAR-Bombesin in prostate cancer.

The BOP Phase II investigator-initiated trial (IIT) will recruit up to 30 patients led by Prof Louise Emmett at St Vincent’s Hospital in Sydney.

The BOP trial will be assessing the safety of 64Cu-SAR-Bombesin as well as looking at the diagnostic potential for men with negative prostate specific membrane antigen (PSMA).

The trial will be imaging with 64Cu SAR-Bombesin on the day of administration, as well as at later time points.

Approximately 20% of prostate cancers with biochemical recurrence (BCR) are PSMA-PET negative.

These patients are therefore unlikely to respond to therapeutic PSMA-targeted products, and currently have few treatment options available to them.

Given that prostate cancer is one of the largest indications in oncology, there is a significant unmet medical need in this segment.

The SAR-Bombesin product targets the Gastrin Releasing Peptide receptor (GRPr) found on up to 100% of prostate cancers as well as many other cancers.

As such, Clarity’s product could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers.

“We believe that SAR-Bombesin has potential to provide large patient populations with accurate and precise detection and treatment of cancers that express the target and deliver clinical, environmental and logistical benefits enabled by the copper isotope pairing,” said Clarity’s executive chairman, Dr Alan Taylor.

Optiscan submits FDA application

Another imaging company, Opstican Imaging (ASX:OIL), also rose 8% after announcing an FDA Pre-Market Notification 510(k) submission of its InVivage device.

InVivage is a non-invasive, instantaneous form of oral imaging, targeting the severe health consequences of late-stage diagnosis of oral cancers and precancerous lesions.

The technology platform enables real-time, non-destructive, 3D, in-vivo imaging at the sub-cellular level which aims to provide physicians, surgeons and pathologists with high resolution microscopic images.

Optiscan’s CEO Professor Camile Farah said this FDA submission is a true landmark achievement for the company.

“This is a key step towards strengthening the commercialisation of the InVivage device, and bringing our revolutionary imaging and real-time pathology technology to the world.

“This submission strengthens the path for commercialisation of InVivage, which is aligned with our new strategic direction, as we continue to move forward in our go-to-market plans as well as actively look to diversify our product offering.”

Recce Pharma completes Cohort 7 of Phase 1

Recce Pharma (ASX:RCE) says 10 subjects in Cohort 7 of its Phase 1 clinical trial in Recce 327 (R327) have been intravenously dosed with R327 at 6,000mg.

An independent Safety Committee Cohort 7 data review is now underway, and Recce anticipates recommendation to proceed to a Cohort 8.

The company notes 6,000mg as being broadly efficacious in animal models previously.

James Graham, CEI of Recce Pharma said: “We are thrilled to have completed dosing of 6,000mg (6 grams) via 1 hour I.V. infusion in our Phase I clinical trial.”

“Achieving a 120-fold increase from Cohort 1 (50mg) with anticipation to soon begin a Cohort 8 continues to build the safety and tolerability profile as a potential new-class of anti-infectives.”

According to PEW Charitable Trust’s global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.

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