Zelira Therapeutics Ltd (ASX:ZLD) (OTCQB:ZLDAF) has revealed positive Phase 1b/2a results confirming that ZLT-101 therapy achieved the primary endpoint of a statistically significant improvement in Insomnia Severity Index scores in patients diagnosed with chronic insomnia.
The Phase 1b/2a trial recruited 24 chronic insomnia patients, aged between 25-70.
The study was a randomised, double-blind, cross-over design involving 14 nights of ZTL-101 and 14 nights of placebo, separated by a one-week washout period.
Primary endpoint 1: safe and well tolerated
A total of 36 non-serious adverse events possibly related to ZTL-101 medication were recorded from 17 participants.
The most frequently reported adverse event was xerostomia (dry mouth) (22.2% of all events) followed by dizziness (16.7%), headache (11.1%) and feeling abnormal (11.1%).
All adverse events were classified as mild and had either resolved (97.5%) overnight or soon after waking each day or were resolving at the end of the trial.
Primary endpoint 2: significant change in ISI scores
Compared to baseline Insomnia Severity Index (ISI) scores (18.0±3.7) a significant decrease was observed following ZTL-101 (12.9±5.3).
The magnitude of decrease in ISI scores following ZTL-101 and placebo were 5.2±4.3 and 0.0±3.3, respectively.
Importantly, the ISI scores following ZTL-101 and placebo were significantly different (p<0.001). >< 0.001).
Principal investigator for the study and director at the Centre for Sleep Science at the University of Western Australia professor Peter Eastwood said: “This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia.
“Its also the first trial to use the Insomnia Severity Index, arguably the current gold standard in this field, to measure the efficacy of a medicinal cannabis product to treat insomnia symptoms.
“The fact that ZLT-101 treatment achieved a statistically significant improvement in ISI scores is very impressive, particularly given the relatively short two-week dosing window.
“The lack of serious adverse or persistent mild adverse events is also encouraging given the reported safety issues for several already approved insomnia therapies.
“Taken together, these results suggest ZLT-101 has potential as a novel treatment for Insomnia.”
“Worlds first clinically validated cannabis medicine for insomnia”
Havilah Resources Ltd (ASX:HAV) will increase rare earth study work at several Curnamona Craton tenements in South Australia after the discovery potential was confirmed by independent expert Ken Collerson.
Collerson noted geochemical similarities with carbonatites from the largest rare earth elements (REE) deposit in the world at Bayon Obo in China to Havilahs Kalkaroo Copper Gold Project and Croziers copper prospect, which has encouraged the company to carry out REE mineralogical and metallurgical recovery studies on drill samples over the next few months.
REE are of relevance and strategic importance given the Australian Governments recent efforts in promoting international investment in the development of critical minerals resources within Australia.
Collerson also observed that because the REE may be recovered as a by-product of the copper-gold concentration process at Kalkaroo, this could potentially provide an economic advantage for the Kalkaroo project compared to those projects that are solely REE based.
Kalkaroo Copper project “at an economic advantage”
Havilah technical director Dr Chris Giles said: “The value upside for Havilah is that if REE can be economically recovered in a mineral concentrate as a byproduct of the standard copper and gold recovery processes it could provide a further revenue stream for the Kalkaroo copper-gold project.
“As Professor Collerson has observed, this potentially puts Kalkaroo at an economic advantage compared with stand-alone REE producers.
“The critical questions for Havilah are what mineral(s) host the REE and can the REE be recovered and concentrated to produce a saleable, direct shipping by-product along with copper concentrates?
“Without detracting from our other work, these are the questions that we propose to address with experimental work over the next few months in collaboration with local well credentialed academic experts.”
Havilah proposes to investigate the REE recovery options, with the following key tasks planned:
Complete shallow drill holes at the Kalkaroo project and Croziers prospect areas to obtain samples that are suitable for metallurgical recovery studies;
Lake Resources N.L. (ASX:LKE) is witnessing an increasing interest in lithium players and projects in northern Argentina, where the lithium brine producer's flagship Kachi Lithium Brine Project is located.
Lakes Kachi and other 100%-owned leases are in a prime location among the lithium sectors largest players within the Lithium Triangle, where about 40% of the worlds lithium is produced.
The region has seen increased acquisition activity recently with Orocobre Limited (ASX:ORE) (TSE:ORL) entering into an agreement to acquire 100% of Advantage Lithium Corp (CVE:AAL) (OTCQX:AVLIF).
Advantage Lithiums Cauchari Lithium Project contains 4.8 million tonnes of measured and indicated lithium carbonate resource and lies only 20 kilometres from Orocobres producing Olaroz lithium facility.
Ganfeng – Lithium Americas project
Earlier this month, world-leading lithium manufacturer Ganfeng Lithium Co Ltd (SHE:002460) agreed to pay US$16 million to Read More – Source
Ants may be tiny critters with tiny brains, but these social insects are capable of collectively organizing themselves into a highly efficient community to ensure the colony survives. And it seems that the social dynamics of how division of labor emerges in an ant colony is similar to how political polarization develops in human social networks, according to a recent paper in the Journal of the Royal Society Interface.
"Our findings suggest that division of labor and political polarization—two social phenomena not typically considered together—may actually be driven by the same process," said co-author Chris Tokita, a graduate student in ecology and evolutionary biology at Princeton University. "Division of labor is seen as a benefit to societies, while political polarization usually isn't, but we found that the same dynamics could theoretically give rise to them both."
Tokita and his adviser/co-author, Corina Tarnita, were collaborating with a group at Rockefeller University that was using camera tracking to study ants—specifically, how division of labor emerges in very small groups (between 12-16 ants). Their job was to devise a model for a behavioral mechanism that would explain the patterns that the Rockefeller people had observed in their experiments. "Originally, we thought social interactions might play a part," Tokita told Ars. "But it turns out we didn't need to think about social interactions to capture their results."
Tokita was familiar with the growing body of research in the social sciences involving opinion dynamics models—that is, how people's opinions can change over time as they interact with and influence each other. And he noticed that the emergence of political polarization within such models was similar to how division of labor emerges among ant colonies.
He thought it should be possible to combine the response threshold model he'd developed for the ants' social dynamics with the basic mechanism behind political polarization: a feedback loop between social influence and interaction bias. Social influence is the tendency of individuals to become similar to those they interact with, while interaction bias describes our tendency to interact with others who are already like us.
In Tokita's original ant model, the ants choose their jobs within the colony based on which need meets a critical internal threshold. For example, if one ant has a lower threshold for hunger, it will be more likely to go forage for food, while another ant with a low threshold for concern about the colony's larvae will devote more time to the nursery. Over time, each ant will have more interactions with other ants with thresholds similar to its, leading to the natural emergence of two groups: foragers and care providers.
This is usually a positive development, since it allows for the efficient functioning of the colony. However, Tokita and Tarnita found that if you add a strong feedback loop between social influence and interaction bias into the model, the two groups soon become so divided that they rarely interact at all, to the detriment of the colony as a whole.
According to Tokita, when only social influence is present, individuals interact randomly and become similar, so no division of labor naturally develops. When only interaction bias is present, individuals don't differentiate, so you don't get social factions. When both social forces are present, a strong feedback loop develops between them, resulting in both division of labor and polarized social networks. As both social influence and interaction bias increase, individual behavior becomes more specialized (biased) and individuals increasingly interact with those who are similar.
"We basically showed that there are critical tipping points where you expect individuals to diverge in their behavior, and that's when there is a strong enough bias towards those [most similar] to you," said Tokita. Interaction bias might still exist below that threshold, but it probably won't be strong enough to produce the strong feedback loop that further reinforces the polarization.
According to Tokita, it is possible to reduce that strong divide simply by interacting a little bit more with those who are less like us, and/or letting our internal thresholds shift a little so we are a little less like our current "in" group. This essentially erases the differences. When that happens, "You don't get division of labor, yRead More – Source
When we opened up that brand-new computer when we were kids, we didnt think of all of the third-party work that made typing in that first BASIC program possible. There once was a time when we didn't have to worry about which companies produced all the bits of licensed software or hardware that underpinned our computing experience. But recent malware attacks and other security events have shown just how much we need to care about the supply chain behind the technology we use every day.
The URGENT/11 vulnerability, the subject of a Cybersecurity and Infrastructure Security Agency advisory issued last July, is one of those. It forces us to care, because it affects multiple medical devices. And it serves as a demonstration of how the software component supply chain and availability of support can affect the ability of organizations to update devices to fix security bugs—especially in the embedded computing space.
URGENT/11 is a vulnerability in the Interpeak Networks TCP/IP stack (IPNet), which was licensed out to multiple vendors of embedded operating systems. IPNet also became the main networking stack in Wind River VxWorks, until Wind River acquired Interpeak in 2006 and stopped supporting IPNet. (Wind River themselves were acquired by Intel in 2009 and spun off in 2018.) But the end of support didnt stop several other manufacturers from continuing to use IPNet. When critical bugs were discovered in IPNet, it set off a scare from the numerous medical device manufacturers that run it as part of their product build.
The average medical or Internet of Things (IoT) device relies on multiple free software or open source utilities. These pieces of software are maintained by any number of third parties—often by just one or two people. In the case of Network Time Protocol (ntp)—software that is in billions of devices—its code is maintained by a single person. And when the OpenSSL Heartbleed vulnerability came out in 2014, the OpenSSL project had two developers working on it. While there are many more developers working on it now, the Heartbleed crisis is emblematic of what happens when we use free software in our devices—the software gets adapted, not really patched, and not really maintained on the device, and little benefit goes back to the project.
Companies are under constant pressure to develop products and reduce expenses. To save time to market and reduce costs, hardware manufacturers often build products using reference designs. These designs come with Board Support Packages, which contain the code and drivers needed to successfully install and run an operating system on the given design. Sometimes they also come with utilities to perform diagnostics, hardware debugging, or monitoring on the devices.
But the Board Support Package is not always updated to address vulnerabilities or newer operating systems. This is the case with many Android devices that continue to be used but don't get software updates—because of kernel changes that the board support packages and drivers do not support. Oftentimes the device manufacturer needs to update these packages for every new version of an operating system. It then needs to rebuild the new version of their operating system and applications on top of it. Third-party components, such as cameras or additional sensors, also need to have their drivers updated. The amount of work needed to do this is significant and requires a degree of testing similar to that of a brand-new device.
Larger manufacturers, such as Samsung, are capable of absorbing the costs and are able to provide device updates at a lower price because they control numerous market segments (display, memory, etc.). Apple is also capable of providing these updates for a number of years because of their control of the supply chain behind their devices, including the processors, and their move away from third-party intellectual property.
But for other manufacturers, the high cost of updating board support packages, associated drivers (when they exist), and applications makes upgrading devices to a whole new version of an operating system difficult. And it often isn't possible to update even one specific component. As a result, the expectations set by the major software companies dont carry over well to markets where you dont sell as many devices, and there is tremendous market pressure to increase earnings.
Medical devices arent smartphones
This sort of thing might not be perceived as a huge problem for consumer devices such as smartphones, where manufacturers try to drive a constant hardware upgrade cycle. But there's an expectation that medical devices will be used longer than other devices—they're considered capital expenses, written into construction budgets for new facilities.
Asking medical device vendors to commit to long-term support for components and long-term supply chain support has a corresponding cost that will be borne by end users. Because of the expense of supporting these devices, many organizations will drop manufacturer support and use a third-party company to provide tech support and device management instead. This removes the incentive for manufacturers to provide additional support.
And medical device vendors don't always have the flexibility to upgrade their underlying platforms because of the way they license components. Since third-party components are usually licensed for a prebuilt function, the license may only allow for their use with a certain version of an operating system or kernel.
While the Linux community has been nothing short of incredible at maintaining older kernel versions and addressing security issues long after newer kernel versions have been released, putting that patched kernel in place takes significant work. There are a lot of dependencies between all the parts, and its very difficult to maintain everything to be able to provide security updates for a particular device or operating system as well as Microsoft, Apple, or IBM Red Hat do at scale. And older kernel and library versions mean that newer software isnt going to be as easy to port over and use, if at all. Getting Apache 2.4 to run on Red Hat Enterprise Linux 5.x, for instance, was an arduous task.
No easy fix
Overcoming the challenges these issues pose to the security of medical devices will be difficult. The Federal Drug Administration's effort to mandate a software bill of materials through their Premarket CybersecurityRead More – Source
BERLIN — German Chancellor Angela Merkels government Wednesday approved a law that forces social media platforms to proactively report illegal content such as death threats or incitement of hatred to law enforcement authorities.
“With the legislative package launched today, were targeting hate crimes with more force than before,” Justice Minister Christine Lambrecht, a Social Democrat, said in a written statement. “In the future, anyone who incites hate and threatens others online will be prosecuted more thoroughly and effectively.”
The law approved Wednesday is one of two pending proposals to further toughen Germanys online hate speech rules, which are considered some of the most stringent in the world. Before taking effect, the law still needs to pass both chambers of Germanys parliament.
Sparring between Mike Bloomberg and the leading Democratic candidates erupted hours before Wednesday nights debate, previewing whats expected to be a tense night as the billionaire businessman meets his rivals onstage for the first time.
NEW DELHI (AFP) – An Indian wrestler whose family story was immortalised by Bollywood is hoping to create a blockbuster of her own by becoming her country's first world champion in the high-octane sport of mixed martial arts (MMA).
Ritu Phogat, who initially followed her father and two elder sisters into wrestling, is now charting a new path after making an explosive MMA debut in November.
Phogat's father Mahavir, and her sisters Geeta and Babita were the subject of 2016 movie "Dangal", telling the story of the wrestling coach who raised his daughters to become Commonwealth champions.
But Ritu, 25, is forging a different career. After winning her first MMA fight in less than three minutes, she will face China's Wu Chiao Chen at this month's ONE Championship fight night in Singapore, which will be held behind closed doors because of the coronavirus.
The youngest Phogat daughter is trading an attempt at an Olympic medal to tackle MMA, but she said she was attracted by the lure of making history in her new sport.
"I got a chance to train with the best in Singapore and there was no looking back," she told AFP during a promotional event in New Delhi.
"There was the 2020 Olympic Games but I thought that I would do well in mixed martial arts. I have come with an aim of becoming the first girl from India to become a world champion in mixed martial art."
The nimble but strongly built Phogat said wrestlers were a good fit for the fast-growing contact sport, which is yet to take off in India.
"Top seven champions in mixed martial arts are wrestlers, so I believe that wrestlers have an edge in this sport with their ability to take down the opponent," she said.
"It is all a matter of skill. You just have to practise hard. I think MMA is not much different from wrestling in terms of preparation." Phogat, who said she was inspired by watching Russia's Khabib Nurmagomedov and Conor McGregor of Ireland, admitted she was running a risk by switching sports.
DORTMUND (AFP) – Brazil superstar Neymar has criticised Paris Saint-Germain's handling of his recent injury after scoring in the 2-1 defeat at Borussia Dortmund, which leaves the French club facing the prospect of another early Champions League exit.
After missing four games in the last fortnight with a rib injury, the Brazilian superstar looked short of match fitness in Tuesday's last-16, first-leg, defeat at Dortmund.
Norwegian goal-machine Erling Braut Haaland scored twice to make him the Champions League joint top-scorer, but Neymar gave PSG a lifeline for the second leg in Paris on March 11.
He tapped home for what could prove a crucial away goal after being set up by France striker Kylian Mbappe in the second half.
Neymar, the world's most expensive player, was critical of the French league champions for not letting him play more before Tuesday's clash.
"It's hard to go four games without playing," said Neymar.
"Unfortunately it wasn't my choice, it was the choice of the club, of the doctors, they made that decision, which I didn't like.
"We had a lot of discussions about it because I wanted to play, I felt good, but the club was afraid and in Read More – Source
Australia batsman Steve Smith says his reception in South Africa has been "lovely" on his first tour since the infamous 'Sandpapergate' scandal, but expects that to change when he steps onto The Wanderers on Friday.
Share this content
JOHANNESBURG: Australia batsman Steve Smith says his reception in South Africa has been "lovely" on his first tour since the infamous 'Sandpapergate' scandal, but expects that to change when he steps onto The Wanderers on Friday.
Australia take on hosts South Africa in the first match of a three-game Twenty20 International series at a ground nicknamed 'The Bull Ring' for its hostile atmosphere, where England's Ben Stokes had an altercation with a fan as recently as last month.
Smith and team mate David Warner were banned by Cricket Australia for a year, and Cameron Bancroft for nine months, after their involvement in an attempt to alter the state of the ball using sandpaper during a test tour of the country in March 2018.
"It's nice to be back playing in South Africa," Smith told reporters on Wednesday. "The last time I was here things didn't end overly well, but Ive also got really fond memories of playing here.