Climate change having 'irreversible' impact on Antarctica
It argues the large changes now unfolding are putting even more pressure on the global climate, sea level and ecosystems.
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The Australian
5 hours ago
- The Australian
LTR Pharma's ED spray makes peer-reviewed journal
LTR Pharma's phase I pharmacokinetic study of nasal spray mist to treat erectile dysfunction published in leading peer-reviewed journal Publication validates five times faster onset, strengthening regulatory pathway and physician adoption LTR Pharma is targeting the US$3.7 billion ED market with SPONTAN and its other intranasal vardenafil formulation ROXUS Special Report: Results of LTR Pharma's phase I pharmacokinetic (PK) study of SPONTAN, its nasal spray mist to treat erectile dysfunction, have been published in the peer-reviewed European Journal of Pharmaceutical Sciences. The publication provides independent validation of SPONTAN – LTR Pharma's (ASX:LTP) lead intranasal vardenafil formulation for ED – including ultra-rapid onset, showing peak plasma concentrations in just 10 minutes compared with 45 minutes for conventional oral ED tablets. Mean Tmax values were 12 minutes for SPONTAN versus 56 minutes for tablets, confirming consistent rapid absorption across participants. Tmax refers to the time it takes for a drug to reach its maximum concentration (Cmax) in the bloodstream after administration. The European Journal of Pharmaceutical Sciences is a leading international peer-reviewed publication that highlights high-impact research in pharmaceutical sciences and drug delivery. Publication in the journal requires rigorous peer review by independent scientific experts and represents significant third-party validation of clinical data quality. LTR Pharma said publication in the journal adds substantial credibility to LTR's regulatory dossier as the company advances towards full commercialisation. "This peer-reviewed validation marks a transformative milestone for LTR Pharma. We now have independent scientific confirmation that our technology delivers what ED patients have been seeking for decades - true spontaneity,' executive chairman Lee Rodne said. About the PK study The randomised crossover study in 18 healthy male volunteers compared SPONTAN nasal spray (5 mg vardenafil) with oral vardenafil tablets (10 mg). Key clinical findings included: Ultra-rapid onset – SPONTAN reached peak plasma concentration (Tmax) in a median of 10 minutes versus 45 minutes for oral tablets, with mean values of 12 minutes versus 56 minutes respectively. Superior efficiency – Despite half the dose, SPONTAN achieved higher bioavailability per milligram, with dose-normalised Cmax of 2.58 ng/mL/mg versus 1.67 ng/mL/mg for oral administration. Comparable duration – Similar half-life of ~4 hours for both formulations, supporting sustained therapeutic effect. Manageable tolerability – Safety profile consistent with the PDE5 inhibitor class, with no serious adverse events reported. While the study specifically evaluated SPONTAN, the PK data support the company's broader intranasal delivery platform for vardenafil, which also includes ROXUS. Both products leverage the same rapid-onset technology, providing LTR with multiple commercial opportunities in different market segments from a single validated drug delivery platform. Targeting increased spontaneity Importantly, the publication notes that current oral PDE5 inhibitors face significant limitations, including delayed onset of 30 minutes to two hours, reduced efficacy with food intake, and the need for careful timing around sexual activity. These factors contribute to discontinuation rates of ~4% per month, with lack of spontaneity cited as a primary reason for treatment abandonment. The study authors concluded that 'intranasally delivered vardenafil is associated with more rapid onset of action with similar plasma concentrations'. They said that 'this differential pharmacokinetic profile has potentially important clinical implications given the overall safety and efficacy profile of PDE5 inhibitors in the treatment of ED, especially in men seeking sexual spontaneity'. Chief medical officer Professor Geoff Strange noted the peer-reviewed publication provided robust scientific validation of SPONTAN's 'game-changing pharmacokinetic profile'. 'The data clearly demonstrate that our intranasal delivery technology achieves the desired therapeutic levels in under 10 minutes – addressing the spontaneity challenge that drives part of the 50% of patients discontinuing oral ED treatments within their first year,' he said. 'From a clinical perspective, this represents a fundamental advancement in how PDE5 inhibitors can be administered, with the potential to significantly improve treatment adherence and patient satisfaction." SPONTAN is currently available in Australia through the Therapeutic Goods Administration Special Access Scheme, while it is targeting approval in other key markets. LTR Pharma is advancing a US Food and Drug Administration (FDA) regulatory submission via the 505(b)(2) pathway for SPONTAN approval with the US ED market valued at US$3.7 billion. The company said the journal publication strengthens its clinical evidence package for regulatory authorities. This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
News.com.au
5 hours ago
- News.com.au
Antarctic climate shifts threaten 'catastrophic' impacts globally
Abrupt and potentially irreversible changes in Antarctica driven by climate change could lift global oceans by metres and lead to "catastrophic consequences for generations", scientists warned Wednesday. More broadly, a state-of-knowledge review by a score of top experts revealed accelerating shifts across the region that are often both cause and effect of global warming, according to a study published in Nature. "Antarctica is showing worrying signs of rapid change across its ice, ocean and ecosystems," lead author and Australian National University professor Nerilie Abram told AFP. "Some of these abrupt changes will be difficult to stop." Shifts in different facets of Antarctica's climate system amplify each other and have accelerated the pace of warming globally as well, she said. The study looked at evidence of abrupt change -- or "regime shifts" -- in sea ice, regional ocean currents, the continent's ice sheet and ice shelves, and marine life. It also examined how they interact. Floating sea ice does not add to sea level when it melts. But its retreat does replace white surfaces that reflect almost all of the Sun's energy back into space with deep blue water, which absorbs the same amount instead. Ninety percent of the heat generated by manmade global warming is soaked up by oceans. - Retreating sea ice - After increasing slightly during the first 35 years that satellite data was available, Antarctic sea ice cover plunged dramatically over the last decade. Since 2014, sea ice has retreated on average 120 kilometres (75 miles) from the continent's shoreline. That contraction has happened about three times faster in 10 years than the decline in Arctic sea ice over nearly 50. The "overwhelming evidence of a regime shift in sea ice" means that, on current trends, Antarctica could essentially become ice free in summer sooner than the Arctic, the study found. This will speed up warming in the region and beyond, and could push some marine species toward extinction. Over the last two years, for example, helpless emperor penguin chicks perished at multiple breeding grounds, drowning or freezing to death when sea ice gave way earlier than usual under their tiny feet. Of five sites monitored in the Bellingshausen Sea region in 2023, all but one experienced a 100 percent loss of chicks, earlier research reported. Unlike sea ice, ice sheets and the ice shelves to which they are connected are on -- or supported by -- land. The world would need to heat up by five degrees Celsius compared with pre-industrial levels to melt the entire Antarctic ice sheet, which would lift global oceans an almost unimaginable 58 metres (nearly 200 feet). - Point of no return - But global warming to date -- on average about 1.3C -- is fast approaching a threshold that would cause part of the ice sheet to generate at least three metres of sea level rise, flooding coastal areas inhabited today by hundreds of millions, the study said. "Unstoppable collapse of the West Antarctic Ice Sheet is one of the most concerning global tipping points," said Abram. "The evidence points to this being triggered at global warming well below 2C." Another potential risk is the collapse of the Antarctic Overturning Circulation, a system of ocean currents that distribute heat and nutrients within the the region and globally. A "rapid and substantial slowdown" of the currents has already begun, and evidence from the previous interglacial period -- between two ice ages -- before our own, 125,000 years ago, points to an abrupt stagnation of the system under conditions similar to those seen today. "This would lead to widespread climate and ecosystem impacts," ranging from an intensification of global warming to a decrease in the ocean's capacity to absorb CO2, the study reported. Ultimately, the only way to slow down the interlocking changes is to stop adding more planet-warming gases into the atmosphere. "The greenhouse gas emission decisions that we make over the coming decade or two will lock in how much ice we will lose and how quickly it will be lost," Abram said. mh/jxb
News.com.au
7 hours ago
- News.com.au
‘No statistically significant decline': Arctic sea ice loss dramatically slows since 2005
A dramatic slowdown in Arctic sea ice loss over the past 20 years has been observed by scientists, who say the finding 'may sound surprising' but is consistent with human-induced global warming trends. Researchers from the University of Exeter, in a study published this month in the journal Geophysical Research Letters, analysed Arctic sea ice cover using two different datasets of satellite measurements, from 1979 to the present. 'Over the past two decades, Arctic sea ice loss has slowed considerably, with no statistically significant decline in September sea ice area since 2005,' they wrote. 'This pause is robust across observational data sets, metrics, and seasons.' Focusing on September, when sea ice cover is at its minimum, they found sea ice declined by 0.35 and 0.29 million square kilometres per decade between 2005 and 2024. Compared with the longer-term rate of decline since 1979 of 0.78 to 0.79 million square kilometres per decade, that marked a 55 per cent to 63 per cent slowdown. The 20-year period was the slowest rate of sea ice loss since records began, and four to five times slower than the peak 20-year period of 1993 to 2012. The researchers said the findings were consistent with climate models that show pauses in sea ice loss across multiple decades can happen, offset by 'natural climate variations' even as greenhouse gas emissions continue to rise. Climate models suggest the chances of such a slowdown were about 20 per cent. Comparing the current slowdown to similar pauses in model simulations, 'we see that it could plausibly continue for another five to 10 years, although the same slowdown makes a faster-than-average sea ice decline more likely in the coming years', they wrote. 'Summer sea ice conditions in the Arctic are at least 33 per cent lower than they were at the beginning of the satellite record nearly 50 years ago,' Dr Mark England, who led the study while at the University of Exeter and is now at UC Irvine, said in a statement. 'Given this — and the indisputable fact of human-driven climate change — it may seem surprising to find a temporary slowdown in Arctic sea ice loss. 'It is, however, entirely consistent with climate model simulations and is likely due to natural climate variability superimposed on the human-driven long-term trend. This is only a 'temporary reprieve' and before long the rate of sea ice decline will catch up with the longer term rate of sea ice loss. 'It's like the analogy of a ball bouncing down a hill where the hill is climate change, given by Professor Ed Hawkins. The ball continues going down the hill but as it meets obstacles in its path, the ball can temporarily fly upwards or sideways and not seem to be travelling down at all — that trajectory is not always smooth but we know that at some point the ball will careen towards the bottom of the hill.' When the current slowdown ends, climate modelling suggests the rate of sea ice loss could accelerate to 0.6 million square kilometres per decade faster than the longer-term trend. The researchers estimate that the current pause has a nearly one in two chance of lasting another five years, and a 25 per cent chance of lasting another 10 years. While most of the evidence from climate models suggest natural climate variations had played a large part in slowing the 'human-driven loss of sea ice', the modelling was inconclusive whether 'changes in the human influence on climate (the 'forced response') have also contributed'. 'Overall, while it may sound surprising that Arctic sea ice loss has slowed down even as global temperatures hit record highs, the climate modelling evidence suggests we should expect periods like this to occur somewhat frequently,' they wrote. It comes as a separate study from researchers at UNSW Sydney and the ANU, published today in the journal Nature, warns of 'catastrophic consequences' for Antarctica unless urgent actions are taken to cut global carbon emissions. 'Rapid change has already been detected across Antarctica's ice, oceans and ecosystems — and this is set to worsen with every fraction of a degree of global warming,' said lead author Dr Nerilie Abram, chief scientist at the Australian Antarctic Division (AAD). Dr Abram said the sudden loss of sea ice in the region has a range of knock-on effects. 'This includes making the floating ice shelves around Antarctica more susceptible to wave-driven collapse,' she said. She warned the West Antarctic Ice Sheet (WAIS) was at severe risk of collapse as global carbon dioxide levels continue to rise. This loss would raise sea levels by more than three metres, threatening coastal cities and communities worldwide. 'Such a collapse would result in catastrophic consequences for generations to come,' she said.
