As with Telix Pharmaceuticals, Clarity is eying a more effective prostate cancer therapy. Pic via Getty Images
Health & Biotech
Radiopharmacy group Clarity Pharmaceuticals (ASX:CU6) will move to phase II of its prostate cancer therapy trial after the first stanza produced “excellent” results.
In the trial, dubbed Secure, 92% of pre-chemotherapy participants (12 out of 13) experienced a drop of 35% or more in their levels of the prostate-specific antigen – PSA – a tell-tale sign of the disease.
The trial is testing Clarity’s copper isotope-based therapy, 67Cu-SAR-bisPSMA.
With the safety watchdogs happy, the trial moves from dose escalation to cohort expansion (phase II) stage, with the number of cycles (dosages) upped from four to six.
The number of enrolled patients increases from 14 to 24.
The last group, cohort four, showed PSA levels continuing to drop in three participants, with an 80%-plus reduction in three cases and a ‘complete response’ in a fourth.
Across all four cohorts, 68% of participants showed PSA reduction, despite the vast majority of the participants (77%) only receiving a single dose.
The company said most of the patients that didn’t respond to the treatment were in the advanced metastatic stage and were in the lowest-dose cohort.
They also had the highest PSA levels when starting the study.
Clarity executive chairman Alan Taylor says the dose escalation approach has not been used wisely in other studies.
“By gradually increasing the dose from one cohort to the next, we have minimised the risk of adverse events and established a favourable safety profile for patients, while also demonstrating that [the therapy] is effective.”
While the market for PSA-targeting therapies is tipped to be worth US$10-15 billion by 2030, many treatments are substandard – and hence the opportunity.
It’s a point not lost on golden stock Telix Pharmaceuticals (ASX:TLX), which has commercialised a prostate cancer imaging product.
But Telix also has a phase III prostate cancer therapeutic trial in train, as well as mid-stage efforts for kidney, brain and blood cancers.
Race Oncology (ASX:RAC) has signed an $8.6 million work order with contract research organisation George Clinical International.
This is to carry out a phase I trial of its repurposed drug candidate, bisantrene.
Bisantrene, or RC220, has anti-cancer properties, but the real point of interest is the ability of the molecule to protect the heart against the effects of chemotherapy agents (anthracyclines).
In some cases, the heart damage is worse than the disease.
Apart from ascertaining safety and dose optimisation, the study will assess the cardioprotective effects.
Enrolling up to 53 adult patients with advanced tumours, the contractor will carry out the open-label, dose escalation trial at sites in Australia, Hong Kong and South Korea.
The patients will receive bisantrene (an anthracycline) along with the standard-of-care chemotherapy, doxorubicin.
The final trial cost will depend on the number of recruited patients and “other variables of trial execution”.
The trial will use a Bayesian design, which avails of probability theory and prior knowledge to maximise the value of an experiment’s results.
This allows for the trial to be carried out with greater flexibility and speed.
The owner of the Travelan anti-diarrhoea brand, Immuron (ASX:IMC) has struck a distribution deal to sell an irritable bowel syndrome (IBS) treatment in Australia and New Zealand.
While Travelan is derived from colostrum (cow’s milk), the IBS treatment ProIBS is derived from a plant.
The active ingredient, AVH-200 has gel-forming components that supports the intestinal mucosal barrier.
Immuron describes the five-year compact, with Sweden’s Calmino Group AB, as a “collaborative fee-free agreement that includes all marketing and sales activities of ProIBS.”
A common condition, IBS affects around three out of 10 people, with females more likely to be afflicted.
Symptoms include abdominal pain or discomfort, stomach bloating and wind, chronic diarrhoea or constipation.
ProIBS fits into the broader digestives and intestinal market, which Immuron cites as a $221 million a year local sector growing at 3.35% per year.
Developed by Calmino, ProIBS has been on the shelves of Swedish apothecaries for more than a decade.
While retirement and aged care is a growing sector given the ageing populace, Regis Healthcare (ASX:REG) remains the only substantive ASX-listed Australian provider following the buyout of Japara, Aveo and Estia Health.
But New Zealand is experiencing the same demographic trends, which makes the ASX-listed Oceania Healthcare (ASX:OCA) one to watch.
Oceania is little known in investor circles here, but it bears a NZ$600 million ($540 million) market cap and operates 46 facilities across Kiwiland.
In a market update his morning, Oceania reported a third (December) quarter sales volume increase of 29%, with resales up 6%.
Management is pleased with sales at its latest developments: the Helier and Waterford in Auckland and Awatere in Hamilton.
“We have a clear priority to continue to increase our sales cadence,” CEO Suzanne Dvorak says.
“Unsold stock remains our biggest lever to reduce debt.”
Speaking of which, Oceania has also refinanced its $NZ500 million syndicated bank debt facility, with “optimal pricing and extended tenor” and no change to covenants.
“The group has no requirement for additional capital or bank borrowings”.
Oceania reported a September half loss of $NZ17.1 million, an unwelcome turnaround from the previous $NZ35.2 million surplus.
The deficit mainly was due to impairments related to a particular site, the refurbished Elmwood in Auckland.
Underlying earnings gained 2.7% to $NZ38.6 million.
The company paused its dividend, citing the need to reduce gearing and improve financial flexibility before resuming payments.
New Zealand is also home to the $NZ3 billion market cap Ryman Healthcare. This one is only NZ-listed, but has extensive operations here.
At Stockhead, we tell it as it is. While Race Oncology is a Stockhead advertiser the company did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
