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NEW YORK, June 18, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc.(NASDAQ: TGTX),today announcedthe presentation of data from the ULTIMATE I & II global, active controlled, Phase 3 trials evaluatingublituximab, the Companys investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide,in patients with relapsing forms of multiple sclerosis (RMS), during the 7th Congress of the European Academy of Neurology (EAN).This data was previously presented at the American Academy of Neurology (AAN) 73rd Annual Meeting.

Oral Presentation Title: Ublituximab versus teriflunomide in relapsing multiple sclerosis (RMS): Results of the Phase 3 ULTIMATE I and II trials

The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion (150mg over four hours). The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Additionally, data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in the third quarter of 2021.

Data highlights from the ULTIMATE I & II Phase 3 studies in patients with RMS include:

Primary Endpoint: Annualized Relapse Rate (ARR) Results

MRI Results

No Evidence of Disease Activity (NEDA) Results

Prespecified Pooled Disability Results

Ublituximab was generally well tolerated with no unexpected safety signals. Overall, the proportion of patients in the ublituximab group with adverse events was similar to the teriflunomide group in a pooled analysis of both studies (approximately 88% in each treatment group); the most common adverse event associated with ublituximab was infusion related reactions (47.7% of patients who received ublituximab experienced at least one infusion-related reaction vs. 12.2 percent for the teriflunomide group).

ABOUT THE ULTIMATE I & II TRIALSULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Both studies have met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide. Key secondary MRI endpoints have also been met. Data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted Q3 2021. Additional information on these clinical trials can be found at http://www.clinicaltrials.gov (NCT03277261; NCT03277248).

ABOUT UBLITUXIMAB Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1

ABOUT TG THERAPEUTICS, INC.TG Therapeuticsis a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from theU.S.FDA for UKONIQ(umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development.For more information, visitwww.tgtherapeutics.com, and follow us on Twitter@TGTherapeuticsandLinkedin.

UKONIQ is a trademark ofTG Therapeutics, Inc.

Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II studies and the Companys plans and timelines for submission of a Biologics License Application (BLA) for ublituximab for the treatment of relapsing forms of Multiple Sclerosis (RMS).

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with theU.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II trials that we announce or publish may change, or the perceived product profile may be impacted, as more data or additional endpoints (including efficacy and safety) are analyzed; the risk that safety issues will emerge despite our belief that there were no unexpected safety signals identified in the ULTIMATE I & II trials ; our ability to complete the BLA submission for ublituximab in RMS within the timeline projected and the risk that FDA will not accept the submission; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS for efficacy, safety or other issues or, if approved, that we will not receive regulatory approval within the timeline projected; the risk that if approved, ublituximab will not be commercially successful; our ability to expand our commercial infrastructure, and successfully launch, market and sell ublituximab in RMS if approved; the Companys reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including ublituximab; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2020and in our other filings with theSEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

_________________________________________________________

1.MS Prevalence. National Multiple Sclerosis Society website.https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020.2.Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.

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TG Therapeutics Announces Presentation of Data from the - GlobeNewswire

As a young teenager, PJ Crocombe had no idea about the career and life opportunities available outside his remote Northern Territory community of Wadeye.

But at age 13 he got a place on the Thamarrurr Youth Indigenous Corporation's programgiving boys and girls from the Daly River region the chance to go to Bright in regional Victoria to finish school.

"Bright has opened so many opportunities for me," he said.

"I did Year 7 and 8 there. Then in Year 9 I got offered a full scholarship at Scotch College in Melbourne, and now I'm atMelbourne Uni doing a Bachelor of Arts majoring in Indigenous studies."

He is now 21 and a director and mentor himself on he corporation's programhelping young people in Wadeye break out of a cycle of welfare dependence.

ABC News: Jane Bardon

While attending school in Bright the young people are caredfor and mentored by Aboriginal house parents in two group homes for girls and boys.

When they finish school their mentors help them prepare for and secure their first jobs.

Many of them start working in the Dumu Balcony training cafe in Bright.

"And also at the brewery, we had someone working there, and then at the school, two people graduated last year and they're working at the school. And then we have another one working in carpet laying," Mr Crocombe said.

ABC News: Jane Bardon

He said he and other young people from Wadeye had to learn basic life skills as part of their training.

"So, for example, time is a different concept in Wadeye, if you tell someone to show up, at say, one, they'll show up at three, or show up earlier and say: you weren't there," he said.

"So training them to really be on time is one of the key parts of the training, and then just work readiness."

Wadeye is one of the NT'slargest remote communities, with a population of 2,300, and half of working-age adults registered as unemployed.

The town is periodically riven by inter-clan violence.

Three of the program's mentors, with their Dumu cafe cook Benny Mullumbuk, recently rode motorbikes 3,800 kilometresfrom Bright to Darwin to raise the profile of the program.

Dallas Mugarra is among the program's mentors who completed the ride this week.

ABC News: Jane Bardon

"In our communities a lot of young people depend on dole and there's not enough jobs, so we're doing something that makes people understand how to not have to depend on someone else to solve your problem, you have to go and do it yourself, take control of your life," he said.

The ride included stops atremote communities along the way, where the mentorscomparedtheir programwith those run by other Aboriginal community groups.

"This ride was to raise awareness and send a message that anything is possible, to anyone out there who is struggling," Bright house parent and mentor Leon Kinthari said.

"On the way we saw and met some of the Indigenous people out there who are doing similar things, and to raise money for the programthat we have.

"Because in remote communities like Wadeye young people are not getting a chance.

"It's really hard for them to stay focused and understand about the western world that is out there."

Supplied:Thamarrurr Youth Indigenous Corporation

Mr Crocombe said even after starting university he saw how it easy it was to get sucked into violence between Wadeye's Aboriginal clans.

"I came back and I was in Wadeye working on a youth programduring the holidays and I got caught up in the family ruffles, and that was not good," he said.

"Then I thought, 'Ineed to get back to Melbourne', so I moved back down, got myself sorted.

"It is really easy to get sucked into it."

Withthe new perspective he hasgained from travelling around Australia and overseas, he has realisedhow limiting life can be for young people who never have the opportunity to leave Wadeye.

"It's really challenging, because where you grew up is all you know," he said.

The group can't offer enough places to families who want them.

Mr Kinthari is happy his son Marcus has now had the opportunity to go through the program.

ABC News: Jane Bardon

"He went through school, right up to Year 12 and then graduated, and he chose to be a PE teacher in [a] Bright school, so I'm really happy with him, I'm really proud, and I guess when he grows up, he's already focused on chasing his goal," he said.

Following their ride, the mentorsare continuing to share their message through social media.

"It's about staying focused, keep going to school, and just smile a lot," Mr Kinthari said.

See the rest here:
The young Aboriginal people inspiring their peers to reject welfare and strive for careers - ABC News

Russian President Vladimir Putin attends a session of the St. Petersburg International Economic Forum (SPIEF) in Saint Petersburg, Russia, June 4, 2021. Sputnik/Vladimir Smirnov/Kremlin via REUTERS

MOSCOW, June 13 (Reuters) - President Vladimir Putin has said Russia would be ready to hand over cyber criminals to the United States if Washington did the same for Moscow and the two powers reached an agreement to that effect.

Putin made the comments in an interview aired in excerpts on state television on Sunday ahead of a June 16 summit with U.S. President Joe Biden in Geneva. Ties between the powers are badly strained over an array of issues.

The Russian leader said he expected the Geneva meeting to help establish bilateral dialogue and revive personal contacts, adding that important issues for the two men included strategic stability, Libya and Syria, and the environment.

Putin also praised Biden for having shown "professionalism" when the United States and Russia agreed this year to extend the New START nuclear arms control treaty.

The White House has said Biden will bring up ransomware attacks emanating from Russia at the meeting. That issue is in the spotlight after a cyber attack disrupted the North American and Australian operations of meatpacker JBS USA.

A Russia-linked hacking group was behind that attack, a U.S. source familiar with the matter said last week.

Asked if Russia would be prepared to find and prosecute cyber criminals, Putin said Russia's behaviour here would depend on formal agreements being reached by Moscow and Washington.

Both sides would have to commit to the same obligations, he said.

"If we agree to extradite criminals, then of course Russia will do that, we will do that, but only if the other side, in this case the United States, agrees to the same and will extradite the criminals in question to the Russian Federation," he said.

The question of cyber security is one of the most important at the moment because turning all kinds of systems off can lead to really difficult consequences, he said.

Reporting by Tom BalmforthEditing by David Goodman

Our Standards: The Thomson Reuters Trust Principles.

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Putin says Russia would accept conditional handover of cyber criminals to U.S. - Reuters

Vice President Harris attends a meeting with CEOs about economic development in the Northern Triangle on May 27. She plans to meet with entrepreneurs on her trip to the region this week. // AP, Jacquelyn Martin

When Vice President Kamala Harris arrives in Guatemala on Sunday for her first foreign trip in office, she'll follow the same politically treacherous path President Joe Biden took when he was in the role. The mission: to help solve deep-seated problems driving tens of thousands of Central American people to try to seek asylum at the U.S-Mexico border.

"She is really picking up where then-Vice President Biden left off," said Symone Sanders, press secretary to Harris.

The record number of migrants has created a humanitarian challenge, as well as massive political headache for the Biden administration. Polling indicates it's a red flag for President Biden, with approval of his handling of immigration much worse than his overall job approval rating.

Biden asked Harris to take on the problem though not all of it. Her portfolio, like his in 2014 and 2015, is to try to address the root causes of the migration crisis. Republicans have criticized Harris for not visiting the border, taking their own trips to draw attention to conditions there.

On her trip, Harris will meet with the Mexican President Andrs Manuel Lpez Obrador and Guatemalan President Alejandro Giammattei, as well as civil society groups and business leaders.

"We have the capacity to give people hope," Harris said at a recent White House event to promote business investments in the region. "And hope, in particular in this case, that if they stay, help is on the way."

Harris' focus is on countries known as the Northern Triangle: Guatemala, Honduras and El Salvador. They've been hit by natural disasters and have problems with violence, corruption and poverty that go back decades. The pandemic has only made matters worse. Six years ago, then-Vice President Biden was in Guatemala talking about some of the very same problems.

"Let me be frank: some in my own government and in the U.S. Congress have asked me, 'How do we know this isn't just going to be business as usual? How is this any different than anything that's come before?'" Biden said on that trip, back in 2015. "Well, the president and I believe that this is the time that it will be different."

But it wasn't different. The leaders have changed, but the problems in the region persist.

"It's really clear we have a refugee crisis in our hemisphere," said Cecilia Muoz, a top aide to former President Barack Obama when he gave Biden this very same vice presidential portfolio. By running the same play now, Biden is signaling that the administration is taking this seriously, Muoz said.

Corruption a top priority: Ziga

The top priority for the United States is getting tough on corruption and anti-democratic practices by governments in the region, said Ricardo Ziga, the State Department's special envoy to Central America.

"This is not us imposing the United States, or imposing U.S. values, or imposing U.S. laws," Ziga told NPR. "All we are saying is, comply with law that is on the books and comply with local demands for accountability."

The message may not go over well. U.S.-Mexico relations have hit some bumps lately, especially when it comes to sharing security intelligence, and U.S. funding of Mexican free speech groups.

Lpez Obrador had a good working relationship with former President Donald Trump, who was focused on Mexico stopping Central American migrants from getting to the U.S. border, but otherwise stayed out of Mexico's affairs, said Carlos Heredia, a Mexican economist at the Center for Research and Teaching in Economics.

"So now it is different. And the president of Mexico does not feel comfortable dealing with a neighbor that is opinionated and has a lot to say about issues that should be of common interest," Heredia said.

Mexico's approach to the migration issue continues to rely heavily on the police and military, said Tonatiuh Guillen Lopez, a researcher at the National Autonomous University of Mexico who resigned as head of Mexico's Immigration Institute after Lpez Obrador sent in the military to stop migrants.

"We still have the control, police, migration plan that was imposed on Mexico by President Trump," Guillen said.

Despite still enjoying high popularity, Lpez Obrador is facing rising criticism for his attacks on the media, defunding independent institutions and publicly criticizing judges who rule against his populist policies. But Mariana Aparicio Ramirez of the Binational Mexico-United States Relationship Observatory said she expects the meeting will focus more on cooperation than U.S. concerns over these issues.

Vaccines on the way

Harris has already announced $310 million in funding to help with immediate food shortages and disaster recovery in the region. She will also arrive with good news about U.S. vaccine sharing. The administration is donating U.S.-produced vaccines to Mexico and the Northern Triangle countries as part of a larger plan to share millions of doses with countries in need.

But beyond this short-term aid, a question looming over Harris's trip is how to make sure this time really will be different from previous U.S. efforts.

"We are taking a very critical eye at the programs that have and have not been successful and looking to scale up ones that have been," said Mazin Alfaqih, a senior adviser to Harris focused on the Northern Triangle. "We're also looking to broaden partnerships, understanding that the U.S. government and foreign assistance alone cannot tackle this problem."

But Alfaqih said Harris needs willing partners in the region. That's something that stymied previous U.S.-led efforts, said Jos Crdenas, who served in the George W. Bush administration.

"The problem year after year is that entrenched interests in these countries are not interested in economic reform," Crdenas said. "They will tell the Yankees everything that they want to hear, but when the Yankees leave, it's back to business as usual."

And while the work Harris is undertaking could yield long-term improvements, Crdenas says there's an immediate political crisis with damning images and heart-wrenching stories coming from the border. He says the Biden administration's softer approach to border enforcement is likely drawing migrants to try to make it, creating pull factors in addition to the strong push factors in these countries.

"The president knew just what kind of buzz saw he was sending his vice president into when he gave her this assignment," said Benjamin Gedan, who worked on Obama's National Security Council and is now at the Wilson Center. He says Harris has an impossible assignment because there's an expectation that she should somehow be able to deliver immediate results.

The problems in the region are all interconnected. Without cutting corruption and violence, it's hard to convince companies to invest. Without investments, job opportunities are limited and people look to America. But all the migration drains human capital, making the region less attractive for business investment.

"One of the ways to help reduce the impulse of migration is to really create a sense of participation in the local economy and opportunities for that to happen," said Eric Farnsworth, who worked on these issues in the Clinton Administration and is now at the Council of the Americas. "That will require some investment, and I think the investment will materialize if the conditions there are appropriate."

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Harris Heads To Guatemala And Mexico As Part Of A 'Buzz Saw' Assignment | NPR - Houston Public Media

Thank you for your report highlighting the governments grab of GPs data (GPs warn over plans to share patient data with third parties in England, 30 May) and the accompanying editorial (The Guardian view on medical records: NHS data grab needs explaining, 30 May). There are even more issues than you cite.

First, the governments website is disingenuous and misleading. At the top it says patients can opt out at any time; at the bottom it says that when opting out, all existing information will be retained only new information will not be collected. It states that there is no deadline, but if you opt out after your records have been uploaded, the existing information will not be deleted.

Second, the websites assurances of anonymity are worthless. Few people realise how easy it is to identify individuals from medical records, even if obvious personal details are removed. If there is enough information to be useful, most patients will be identifiable.

Third, a massive centralised database cannot be adequately secured against serious attack or accidental breach. There are other less risky means of achieving the same ends, as demonstrated by the Covid research cited in the editorial.

Fourth, there is no discussion of what will actually be shared the data or access to the data. If the data itself is shared, there is no way to control how it is used once it is in the hands of a third party; if only the ability to query the data under monitored conditions is shared, the holder remains in control.

And finally, there is minimal detail on the governance of access to the information, and no mention of any independent body responsible either to the public or to the medical professions.

NHS data is a major potential resource for medical research. However, its use must be carefully managed and controlled, both to retain public trust and to satisfy medical ethics. I strongly support your call for the programme to be scrapped and restarted with suitable technology and safeguards.Alan RectorEmeritus professor of medical informatics, University of Manchester

Your editorial said: Allowing access to NHS data has led to some groundbreaking research, notably helping to identify dexamethasone as an effective Covid therapy.

This is not relevant to the issue of data scraping from primary care. Patients recruited into the Recovery trial give consent before they are randomised into the study. As you can see on the studys website, data for the trial is collected within the hospital. Some data may be collected later from NHS Digital or other databases, but patients are able to withdraw consent for collection of their data from other sources at any time.Irene StrattonOxford

The headline on your report implies that all doctors are opposed to NHS Digitals General Practice Data for Planning and Research scheme itself. In contrast, your article shows that the Royal College of General Practitioners and the British Medical Association were involved in planning the scheme. Their concern is about the way NHS Digital has failed to communicate with patients about it, leaving this to general practitioners, who have been poorly informed themselves.

Explanations are clearly needed, especially about the handling of sensitive data and the projects for which permission can be obtained, as social media is now increasingly full of misinformation. NHS Digital and Health Data Research UK seem to be disinclined to provide the explanations needed, GPs are too busy and Matt Hancock could not be trusted. In this vacuum, why doesnt the Guardian commission some of the researchers hoping to use the data to explain their research and how it will benefit the public, especially as the first example that NHS Digital cites is to Research the long-term impact of coronavirus on the population?Alison MacfarlaneProfessor of perinatal health, City, University of London

Ive been invited by our clinical commissioning group to an understanding and using patient data workshop (GPs urged to refuse to hand over patient details to NHS Digital, 1 June). Date of meeting: 29 June. Date of deadline for opting out my medical record from the big upload: 23 June.Robert OultonGodalming, Surrey

For those readers who wish to opt out of the NHS data grab (The Tories have worked out how to pull off an NHS data grab: do it during a pandemic, 5 June), the NHS Digital website will send you round in circles. Just go to the web page medconfidential.org/how-to-opt-out and you will find the link instantly. The completed form must be handed physically to your GP surgery by the 23 June deadline.Celia BerridgeRodmell, East Sussex

Have an opinion on anything youve read in the Guardian today? Please email us your letter and it will be considered for publication.

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The NHS data grab: why we should be concerned about plans for GPs records - The Guardian