Paradigm Biopharmaceuticals Ltd (ASX:PAR) expects to release results for its Zilosul treatment for osteoarthritis under the US Food and Drug Administration's (FDA) Investigational New Drug expanded access program (EAP) in early August.
The results will include a video detailing the patients under the EAP and their previous struggles with osteoarthritis caused by joint issues during their professional NFL careers and will highlight outcomes and results after completion of the Zilosul ® treatment program.
All patients have completed their follow-up screenings and the EAP database has been locked for data cleaning and preparation of patient results.
The company said it remained focused on its IND submission to the FDA for the remainder of 2020.
The Paradigm team and its consultants continue to compile the necessary information and data for submission towards the end of the fourth quarter.
Shares have been as much as 13.5% higher to $3.21.
Paradigm Biopharmaceuticals is continuing to prepare information requested by the Therapeutic Goods Administration (TGA) for the next stage of submission for the Provisional Approval determination for the use of Zilosul in the treatment of osteoarthritis.
It will update the market on the progress of this process in the fourth quarter this year.
There is additional new data on 67 patients treated under the Special Access Scheme (SAS) program and the company expects to report on 35 patients in the third quarter with the remaining patient data expected to be available in early fourth quarter this year.
The data will be presented, using the same endpoints and product identified for Paradigms Phase 3 trials. This will take the total number of SAS patients reported on with the proposed Phase 3 endpoints to over 100 patients.
Commercial research deal
Paradigm Biopharmaceuticals is in the process of finalising a commercial research agreement with an unnamed Australian university.
The research program will investigate the safety and efficacy of injectable Pentosan Polysulfate Sulfate (iPPS) in a viral-induced respiratory disease model.
Additional details on this agreement will be released to the market once this has been completed.
Proposed Phase III
The primary and secondary endpoints for Paradigms proposed Phase 3 trial will be
➢ Reduced WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain from baseline; and
➢ Improved Patient Global Impression of Change (PGIC).
Paradigm plans to conduct two randomized controlled Phase 3 clinical trials consisting of 750 patients in the first Phase 3 trial and 400 patients in the second Phase 3 trial (confirmatory study).
Paradigm expects to receive notification from the Ethics Committee on its MPS-1 (Mucopolysaccharidosis) clinical program in the current quarter.
It is also expecting feRead More – Source
Saudi women in Sydney: Sisters’ bodies lay undiscovered for a month
Australian police are baffled after the bodies of two Saudi women, believed to have lain undiscovered for a month, were found in a Sydney apartment.
Sisters Asra Abdullah Alsehli, 24, and Amaal Abdullah Alsehli, 23, were found dead on 7 June in separate beds at home in the suburb of Canterbury.
Police, who were called to the property for a welfare check, said the women are believed to have died in early May.
But despite “extensive inquiries”, they still do not know how or why.
The sisters moved to Australia from Saudi Arabia in 2017 and may have sought asylum, The Sydney Morning Herald reported. Police refused to confirm this, saying they do not comment on residential status.
A human rights organisation said it should be established whether the women fled Saudi Arabia because of domestic violence or harsh laws governing women. However, there is no evidence this is the case.
Police said they had been in contact with the women’s family, which is assisting them with inquiries.
Lina al-Hathloul, head of monitoring and communications at Saudi human rights organisation ALQST, said it “would not be the first case” of Saudi women who were killed abroad after fleeing domestic violence.
“There are no protections for women who are victims of domestic violence in Saudi Arabia, so they flee abroad,” she told the BBC.
She added: “I’m not saying that is the case here, just that we need a thorough investigation. It is frustrating not to have any information.”
According to the Sydney Morning Herald, there had been signs that something was wrong.
Last year, the women told their building manager they thought someone was tampering with their food deliveries, the paper reported.
A plumber who visited the apartment also said he believed there was “something mysterious” going on, and that police had been called in the past over concerns for the women.
New South Wales Police issued a renewed plea to the public on Wednesday, saying “any piece of information” could be the key to solving this case.
The local community is close-knit, police said in a statement, asking anyone who may have known or seen the women to come forward.
A report from Australian current affairs programme Four Corners in 2019 found 80 Saudi women had tried to seek asylum in Australia in recent years. Many of them were fleeing male guardianship laws.
Australia election: Why is Australia’s parliament so white?
With this year’s election, political parties did have a window to slightly improve this. But they chose not to in most cases, critics say.
Tu Le grew up the child of Vietnamese refugees in Fowler, a south-west Sydney electorate far from the city’s beaches, and one of the poorest urban areas in the country.
The 30-year-old works as a community lawyer for refugees and migrants newly arrived to the area.
Last year, she was pre-selected by the Labor Party to run in the nation’s most multicultural seat. But then party bosses side-lined her for a white woman.
It would take Kristina Kenneally four hours on public transport – ferry, train, bus, and another bus – to get to Fowler from her home in Sydney’s Northern Beaches, where she lived on an island.
Furious locals questioned what ties she had to the area, but as one of Labor’s most prominent politicians, she was granted the traditionally Labor-voting seat.
Ms Le only learned she’d been replaced on the night newspapers went to print with the story.
“I was conveniently left off the invitation to the party meeting the next day,” she told the BBC.
Despite backlash – including a Facebook group where locals campaigned to stop Ms Kenneally’s appointment – Labor pushed through the deal.
“If this scenario had played out in Britain or the United States, it would not be acceptable,” says Dr Tim Soutphomassane, director of the Sydney Policy Lab and Australia’s former Race Discrimination Commissioner.
“But in Australia, there is a sense that you can still maintain the status quo with very limited social and political consequences.”
An insiders’ game
At least one in five Australians have a non-European background and speak a language at home other than English, according to the last census in 2016.
Some 49% of the population was born or has a parent who was born overseas. In the past 20 years, migrants from Australia’s Asian neighbours have eclipsed those from the UK.
But the parliament looks almost as white as it did in the days of the “White Australia” policy – when from 1901 to the 1970s, the nation banned non-white immigrants.
“We simply do not see our multicultural character represented in anything remotely close to proportionate form in our political institutions,” says Dr Soutphomassane.
Compared to other Western multicultural democracies, Australia also lags far behind.
The numbers below include Indigenous Australians, who did not gain suffrage until the 1960s, and only saw their first lower house MP elected in 2010. Non-white candidates often acknowledge that any progress was first made by Aboriginal Australians.
Two decades ago, Australia and the UK had comparably low representation. But UK political parties – responding to campaigns from diverse members – pledged to act on the problem.
“The British Conservative Party is currently light years ahead of either of the major Australian political parties when it comes to race and representation,” says Dr Soutphomassane.
So why hasn’t Australia changed?
Observers say Australia’s political system is more closed-door than other democracies. Nearly all candidates chosen by the major parties tend to be members who’ve risen through the ranks. Often they’ve worked as staffers to existing MPs.
Ms Le said she’d have no way into the political class if she hadn’t been sponsored by Fowler’s retiring MP – a white, older male.
Labor has taken small structural steps recently – passing commitments in a state caucus last year, and selecting two Chinese-Australian candidates for winnable seats in Sydney.
But it was “one step forward and two steps back”, says party member and activist Osmond Chiu, when just weeks after the backlash to Ms Le’s case, Labor “parachuted in” another white candidate to a multicultural heartland.
Andrew Charlton, a former adviser to ex-PM Kevin Rudd, lived in a harbour mansion in Sydney’s east where he ran a consultancy.
His selection scuppered the anticipated races of at least three diverse candidates from the area which has large Indian and Chinese diasporas.
Party seniors argued that Ms Kenneally and Mr Charlton – as popular and respected party figures – would be able to promote their electorates’ concerns better than newcomers.
Labor leader Anthony Albanese also hailed Ms Kenneally as a “great Australian success story” as a migrant from the US herself.
But Mr Chiu says: “A lot of the frustration that people expressed wasn’t about these specific individuals.
“It was about the fact that these were two of the most multicultural seats in Australia and these opportunities – which come by so rarely – to select culturally diverse candidates were squandered.”
He adds this has long-term effects because the average MP stays in office for about 10 years.
The frustration on this issue has centred on Labor – because the centre-left party calls itself the “party of multiculturalism”.
But the Liberal-National government doesn’t even have diversity as a platform issue.
One of its MPs up for re-election recently appeared to confuse her Labor rival for Tu Le, sparking accusations that she’d mixed up the two Asian-Australian women – something she later denied. But as one opponent said: “How is this still happening in 2022?”
Some experts like Dr Soutphommasane have concluded that Australia’s complacency on areas like representation stems from how the nation embraced multiculturalism as official policy after its White Australia days.
The government of the 1970s, somewhat embarrassed by the past policy, passed racial discrimination laws and “a seat at the table” was granted to migrants and Indigenous Australians.
But critics say this has led to an Australia where multiculturalism is celebrated but racial inequality is not interrogated.
“Multiculturalism is almost apolitical in how it’s viewed in Australia,” Dr Soutphommasane says, in contrast to the “fight” for rights that other Western countries have seen from minority groups.
What is the impact?
A lack of representation in parliament can also lead to failures in policy.
During Sydney’s Covid outbreak in August 2021, Fowler and Parramatta electorates – where most of the city’s multicultural communities reside – were subject to harsher lockdowns as a result of a higher number of cases.
How will things change?
Liberal MP Dave Sharma, the only lawmaker of Indian heritage, has said all parties – including his own – should better recruit people with different backgrounds. He called it a “pretty laissez-faire attitude” currently.
Mr Albanese has urged Ms Le to “hang in there”, insisting she has a future.
But more people like Ms Le are choosing to speak out.
“I think I surprised a lot of people by not staying quiet,” she told the BBC.
“People acted like it was the end of my political career that I didn’t toe the party line. But… none of that means anything to me if it means I’m sacrificing my own values.”
She and other second-generation Australians – raised in a country which prides itself on “a fair go” – are agitating for the rights and access their migrant parents may not have felt entitled to.
“Many of those from diverse backgrounds were saying they felt like they didn’t have a voice – and that my case was a clear demonstration of their suppression, and their wider participation in our political system.”
She and others have noted the “growing distrust” in the major parties. Polls are predicting record voter support for independent candidates.
“This issue…. matters for everyone in Australian society that cares about democracy,” says Mr Soutphommasane.
“If democratic institutions are not representative, their legitimacy will suffer.
Scott Morrison effectively ditches his promise to establish a federal anti-corruption commission
Scott Morrison has effectively abandoned his promise to establish a federal anti-corruption watchdog, confirming he would only proceed with legislation in the new parliament if Labor agreed to pass the Coalition’s heavily criticised proposal without amendments.
Morrison pledged before the 2019 election to legislate a federal integrity body in the parliamentary term that has just ended. The prime minister broke that promise, failing to introduce his own proposal before the 46th parliament was prorogued.
On the hustings on Wednesday, Morrison was asked – given his previous undertaking to create the body – whether he would promise to put his proposal to a vote in the next parliament in the event the Coalition won the 21 May election.
Morrison declined to make that promise. “Our position on this hasn’t changed,” the prime minister said. “Our view has been the same – when the Labor party is prepared to support that legislation in that form, then we will proceed with it.”
The prime minister has attempted to inoculate himself from criticism about breaking an election promise by saying he tabled the integrity commission proposal in the parliament.
Tabling an exposure draft, which is what the prime minister did, is not the same as introducing finished legislation to the House of Representatives or the Senate that is then debated and voted on.
As well as repeatedly fudging what happened in parliament, Morrison has also created the impression the proposal can only proceed if Labor agrees to its passage without amendments.
All governments routinely introduce legislation for debate without any undertaking that it will be passed by the opposition. Labor favours a stronger model than the Coalition’s proposal.
Morrison’s lack of urgency on the issue created tensions within government ranks. Late last year, the Tasmanian Liberal MP Bridget Archer crossed the floor to support independent MP Helen Haines’ bill to establish a federal integrity commission. Archer accused the government of “inertia” over the issue.
At that time, Archer said she was “perplexed” at her own government’s failure to release a revised bill almost three years after it was promised before the last election.
While Morrison clearly wants to move on from the issue, he will face renewed pressure from crossbench independents if the coming election is close enough to deliver a hung parliament.
A number of independents running against Liberals in metropolitan seats have made it clear that establishing a credible national integrity commission will be a key demand in the event any new government – Liberal or Labor – is seeking agreements for confidence and supply.
Haines blasted Morrison’s comments on Wednesday. “Mr Morrison broke an election promise to introduce an anti-corruption commission and his pathway to creating one is still as vague as it was in the last parliament,” she said.
The crossbench independent said it was “nonsense” for the prime minister to claim that he could not proceed unless Labor agreed with the Coalition’s proposal without seeking any amendments. “It would appear we are in the same void as we were before,” Haines said.
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