Health Check: There's no Biden time as Clarity launches prostate cancer study aimed at early detection
Clarity is poised to launch its second phase III prostate cancer imaging trial
LTR Pharma shares swell 30% on the back of local chemist deal
Trajan shares measure up at 70% above their current value
In launching its second phase III trial pitched at US regulatory approval for nuclear medicine diagnostics, Clarity Pharmaceuticals (ASX:CU6) channels the experiences of both Joe Biden and our own Barnaby Joyce.
This week it emerged that the former president is being treated for an aggressive prostate cancer.
After the federal election campaign, Nationals MP Joyce revealed he underwent an operation after being diagnosed early, thanks to a GP visit and a routine prostate specific antigen (PSA) test.
Clarity executive chair Dr Alan Taylor says news that Biden's cancer had metastasised to the bone 'is yet another reminder that no man is safe from this insidious disease'.
About 3.3 million US men have prostate cancer, while Joyce joins more than 250,000 Australian blokes with the malady.
'These large numbers highlight the need for more timely and accurate diagnosis to safely and effectively treat the cancer with suitable therapies,' Taylor says.
Dubbed Amplify, Clarity's trial tests the efficacy of its copper-isotope based agent - 64Cu-SAR-bisPSMA - to diagnose prostate cancer recurrence.
Enrolling around 220 patients at local and US sites, the single arm, open label study will test for rising or detectable signs of the telltale PSA after initial definitive treatment.
The patients will be evaluated on the day of administration and 24 hours thereafter.
Clarity also has started recruiting for a 383-patient, 20-site trial. This one is to image patients with confirmed prostate cancer prior to undergoing radical prostatectomy (prostate removal).
Clarity hopes the data will support earlier positive I/II trial results and pave the way for eventual US Food & Drug Administration (FDA) approval.
Peer review suggests Trajan is undervalued
Broker Bell Potter opines that there's almost 70% of upside in shares in Trajan Group (ASX:TRJ), which makes scientific instruments and related consumables for the biological, environmental and food testing sectors.
The firm says recent results from Trajan's global peers point to destocking of customer inventory that had swelled post pandemic.
The firm notes demand for liquid chromatography and mass spectrometry testing – the mainstay of Trajan's business.
There's also swelling need to test for PFAS, the so-called 'forever chemicals' prevalent in our water and soil.
'Recent environmental legislation in the US appears to be a key long-term driver of a sector that could exceed US$200 billion of value,' the firm says.
Trajan reported softer March quarter sales, owing to 'geopolitical and trade tensions'. But the company is benefiting from the destocking trend, with signs of a recovery in the subdued pharmaceutical sector.
Bell Potter forecasts revenue of $162.5 million for the year to June 30, 5% higher, with last year's net loss of $25.3 million morphing into a slender $2.7 million profit.
Bell Potter values Trajan at $1.50 per share.
LTR Pharma firms up on pharmacy deal
LTR Pharma's (ASX:LTP) nasal spray mist, erectile dysfunction treatment Spontan will become available at 600 more local pharmacies, under a tie-up with the Terry White Chemmart chain.
An alternative to oral meds such as Viagra, Spontan is yet to be approved by the local Therapeutic Goods Administration (TGA).
But it can be accessed under the TGA's Special Access Scheme and Authorised Prescriber Scheme.
The company describes the tie-up as a 'pivotal milestone in LTR Pharma's access and readiness' strategy.
'Patients can now have their Spontan prescriptions filled at participating pharmacies nationwide, providing a direct pathway from healthcare professional to pharmacy dispensing.'
LTR has also produced new barcoded commercial packaging for Spontan, incorporating TGA-compliant labelling, patient information materials, and pharmacy-standard barcodes.
'These barcodes are designed to enable integration with future telehealth platforms, providing patients with a direct and streamlined pathway to healthcare professionals for consultation and prescribing.'
Terry White Chemmart is owned by the ASX-New Zealand listed EBOS Group (ASX:EBO).
Earlier, LTR struck a deal with drug wholesaler Symbion to distribute to 3900 pharmacies.
The company says the special access usage will add to its 'real world' evidence about Spontan's efficacy.
This will support LTR's plans to seek TGA and FDA marketing approval.
LTR also plans to launch a variant called Roxus in the US in 2026, under a pre-approval compounding pharmacy pathway.
Trials to date show that Spontan is absorbed into the blood 470% faster than traditional ED tablets, with men ready for action in as little as five minutes.
The company cites a global market of 330 million ED suffers, with the US accounting for 30 million.
Fly away, little birdie
Having formed Nyrada (ASX:NYR) eight years ago, Noxopharm (ASX:NOX) is severing links with its grown-up 'child' by disposing of its 18% Nyrada stake.
If only ejecting 20-something kidults from the family hotel – er, home – were just as easy.
The holding is being acquired by a syndicate of current and new Nyrada holders, with Nyrada's board and management accounting for about 26%.
Nyrada is furthering its small molecule lead drug candidate NYR-BI03, to treat ischemic stroke, traumatic brain injury and myocardial ischemia-reperfusion injury (incurred when blood supply is restored, ironically).
Nyrada has launched a first-in-human phase I trial is underway, covering neuroprotection and cardio protection.
Noxopharm, meanwhile is focused novel treatments for cancer and inflammation, including improving the safety of genetic medicines.
Noxopharm says the $2.5 million of non-dilutive funds in part will support its upcoming Heracles clinical trial, targeting the autoimmune disease lupus.
Noxopharm's Nyrada stake consists of a tad over 33.3 million CHESS Depository Interests.
This stock is being sold via an off-market process at 7.5 cents a pop - a 25% discount to yesterday's closing price.
Nyrada listed in 2020. Both companies now have market valuations of around $20 million, so my do those teenagers grow.
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