• Clarity Pharma reports success in Phase 1 study
  • Antisense gets approval in Turkey
  • Radiopharm to list on Nasdaq Capital Market


Radiopharmaceutical specialist, Clarity Pharma (ASX:CU6), has announced favourable results from its Phase I clinical trial, with the share price up 3% this morning on the news.

The Phase 1 trial of 64Cu SAR-bisPSMA in prostate cancer was found to be safe and well tolerated by trial participants.

The data is currently being presented via a poster at the American Society of Clinical Oncology Genitourinary Symposium in San Francisco.

The Phase 1 trial, also called PROPELLER trial, evaluated 30 patients with confirmed prostate cancer prior to undergoing radical prostatectomy (surgical removal of the prostate), and lymph node dissection (removal).

In addition to the primary and secondary endpoints, the study also compared the diagnostic properties of Clarity’s 64Cu SAR-bisPSMA versus current approved standard-of- care, 8Ga PSMA-11.

The comparison evaluated prostate cancer detection and the intensity of product uptake within the same lesions.

The higher the uptake, the brighter and more visible the lesion appears on the scan.

The results showed greater uptake into cancer lesions for 64Cu SAR-bisPSMA, which may enable diagnosis of additional and smaller lesions.

“We are continuing to work diligently towards the start of the diagnostic Phase III trial of SAR-bisPSMA in the US in order to make this product available to the patients who need it most,” said Clarity executive chairman, Dr Alan Taylor.


Antisense gets OK in Turkey

Antisense Therapeutics (ASX:ANP) surged 10% after announcing that it has received regulatory authority approval from the Turkish regulator to conduct its Phase IIb trial.

The Phase IIb is a double-blind, placebo controlled trial which is studying the effects of lead drug ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD).

This first trial approval by a regulatory authority is an important milestone, affirming the quality of the trial design and critically, in providing the ‘green light’ for patient enrolment.

The study aims to enrol and randomise 45 boys with DMD from multiple clinical trial sites in Europe and Australia.

Following the initial six-month regimen of either placebo, 25 mg or 50 mg ATL1102 once weekly (blinded phase), the boys will continue into a further six-month open label treatment period.

The company expects trial approvals in Bulgaria, the UK and Australia to come through in a staggered manner, depending on the respective regulator’s timelines.


Radiopharm goes to Nasdaq

Radiopharm Theranostics (ASX:RAD) announced that it has initiated the process to obtain a secondary listing on the Nasdaq Capital Market.

The Nasdaq listing will take the form of a Level 2 American Depositary Receipt program, with each American Depositary Share representing 100 ordinary shares.

This means there will be no raising of any capital, and will just complement the existing primary listing of RAD shares on the ASX.

The decision to go to Nasdaq is is part of an ongoing strategy to expand the company’s reach to US institutional and retail investors.

“We are confident that obtaining a listing on Nasdaq will complement our loyal existing Australian shareholder base by expanding Radiopharm’s access to investors globally, and thereby driving increased shareholder value with enhanced liquidity for all shareholders,” said Riccardo Canevari, CEO of Radiopharm.


Other notable ASX healthcare news today

Opthea (ASX:OPT) announced that its Phase 2b study results of OPT-302, have been published online in Ophthalmology, the journal of the American Academy of Ophthalmology.

The results demonstrated that monthly intravitreal administration of 2.0 mg OPT-302 with ranibizumab standard of care has met the primary efficacy endpoint of the study.

Neurotech (ASX:NTI) rose 2% after announcing that a Human Research Ethics Committee (HREC) approval has been secured to extend its Phase I/II Autism Spectrum Disorder (ASD) clinical trial.

Based on today’s HREC extension, individual patients can continue to receive NTI164 for an additional six months over the 54 week treatment period.

This represents a total of 80 weeks or 1.5 years of daily NTI164 treatment, which will generate a substantial amount of additional safety data for Neurotech.



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