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A medical play developing CBD-based treatments for cardiovascular diseases

It can be hard to wrap your head around the number of…
The post A medical play developing CBD-based treatments for cardiovascular diseases appeared first…

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Source: Cardiol Therapeutics Inc. Adapted from Lee W-S et al. (2016). Mol. Med. 22, 136-146

It can be hard to wrap your head around the number of diseases and conditions that people live with every day, but almost everyone knows someone that is affected by heart disease.

Around 73,000 people in the United States live with acute myocarditis and approximately 38,000 live with recurrent pericarditis, but there are several intriguing medical plays that are advancing unique treatments, and one among those that is clearly ahead of the pack.

Myocarditis is inflammation of the heart muscle (myocardium) that can reduce the heart’s ability to pump blood and pericarditis is the swelling and irritation of the thin, saclike tissue surrounding the heart.

Both can cause sharp chest pain, shortness of breath, and rapid or irregular heart rhythms. Many viruses have been linked to myocarditis, including those that cause the common cold (adenovirus); COVID-19; hepatitis B and C; parvovirus.

Focusing on this area of medicine is a clinical-stage life sciences company, Cardiol Therapeutics Inc. (TSX:CRDL).

The Company is engaged in the research and clinical development of cannabidiol (CBD) as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases (CVD). Its lead product candidate, CardiolRx™, is a pharmaceutically produced oral CBD formulation that is currently being evaluated in a Phase II/III multi-national study, the LANCER trial. The trial is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence of CardiolRx™ has on key biomarkers associated with heart disease.

The LANCER trial came about because of circumstances falling out from the COVID-19 pandemic. It will provide valuable information for the Company’s focus – inflammatory heart disease.

It is the Company’s most advanced trial since last year and the team has expanded it into Brazil and Mexico. Cardiol has also modified the protocol such that initially when they were only enrolling non-vaccinated patients, now vaccinated patients can participate in the trial, plus other parameters that have been included to further increase the potential patient pool.

Cardiol has also received Investigational New Drug (IND) authorization from the U.S. Food and Drug Agency (FDA) to conduct clinical studies to evaluate CardiolRx™ in two orphan drug indications:

One is a Phase II multi-national trial in acute myocarditis, expected to commence imminently, and the other is a multicenter Phase II open-label pilot study in recurrent pericarditis, to run in parallel.

The Phase II multi-national trial:

Acute myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle, which may result in chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances.

Given the risk of significant heart failure associated with acute myocarditis, current intervention includes drugs commonly administered for heart failure. However, no generally accepted treatment exists for acute myocarditis.

Compelling evidence has already been published that supports CBD’s anti-inflammatory and anti-fibrotic properties, promoting its use for inflammatory heart disease.

Source: Cardiol Therapeutics Inc.

A publication in the Journal of the American College of Cardiology found that CBD has properties that can reduce inflammation and protect heart function, in a model of diabetic cardiomyopathy. It was also noted to significantly decrease cardiac fibrosis (scarring of the heart muscle) in a non-ischemic model of heart failure. Data published in an issue of Molecular Medicine also found that it can reduce cardiac inflammatory cytokine levels in a model of experimental autoimmune myocarditis (inflammatory heart failure).

Cardiol believes it has the opportunity to develop its oral CardiolRx™ formulation as an orphan drug for the treatment of acute myocarditis and recurrent pericarditis.

A major cause of sudden death in children and young adults, acute myocarditis can progress to dilated cardiomyopathy and heart failure. Severe cases can lead to extensive intensive care unit visits and expensive hospital costs.

The Phase II double-blind, randomized, placebo-controlled acute myocarditis study is designed to study the safety and tolerability of CardiolRx™ as well as its impact on myocardial recovery in patients presenting with acute myocarditis. It is expected to enroll 100 patients in 20 to 30 clinical centres across North America, Latin America, Europe, and Israel.

More recently, Cardiol received IND authorization from the FDA to conduct a Phase II open-label pilot study designed to evaluate the tolerance and safety of CardiolRx™ in patients with recurrent pericarditis. The study will also assess the improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™.

Although generally self-limited and not life-threatening, acute pericarditis is diagnosed in 0.2% of all cardiovascular in-hospital admissions and is responsible for 5% of emergency room admissions for chest pain in North America and Western Europe. Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4–6 weeks following an episode of acute pericarditis. These recurrences appear in 15% to 30% of acute cases and usually within 18 months. Further, up to 50% of patients with a recurrent episode of pericarditis experience more recurrences.

Since both acute myocarditis and recurrent pericarditis are orphan diseases in the United States, CardiolRx™ is eligible for orphan drug status under the FDA’s Orphan Drug Designation (ODD) program. The ODD program provides significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees.

Looking ahead:

Medical plays often have very elaborate timelines, but the targets are always in motion.

This year, Cardiol Therapeutics has a lot of potentially exciting milestones remaining to achieve. Once the analysis of its trials is released, it will be like the starting pistol of a race has been fired, leading to more studies and product development.

Source: Cardiol Therapeutics Inc.

Financial position:

In terms of finances, Cardiol Therapeutics sits on more stable ground than many others in the biotech space, which is one of its biggest differentiators. Where many medical plays are often sufficiently cashed to operate to the next year, trials often take much longer, especially if it doesn’t conclude on schedule or see an unfavourable result in the end.

Cardiol has reduced this risk and is well funded to 2024, solidly supporting its research and clinic development programs.

Source: Cardiol Therapeutics Inc.

Meet the team:

Cardiol Therapeutics is led by a top team of who’s who of inflammatory heart disease across the board.

The Company’s President and Chief Executive Officer, David Elsley, MBA came to the role having served as founder and former President and CEO of Vasogen Inc. He has more than 30 years of experience developing, financing and managing the corporate development of life sciences companies.

His time at Cardiol represents his second take at success in cardiac research and brings with him much of his same team who has been focused on treating heart failure.

Dr. Guillermo Torre-Amione, MD, Ph.D., Chairman of Cardiol Therapeutics is a board-certified cardiologist who studied under renowned Dr. Michael DeBakey, whose claim to fame is the first successful heart transplant in North America. Dr. Torre is a Professor of Cardiology at the Methodist Hospital Research Institute, Professor of Medicine at the Weill Cornell Medical College of Cornell University, and President of TecSalud. Former Chief of the Heart Failure Division and former medical director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.

Recently, the Company appointed Teri Loxam, MBA and Chris Waddick, MBA, CPA, CMA to its Board of Directors.

Loxam has over 25 years of experience in the pharmaceutical, life sciences, and entertainment industries. Her diverse roles included strategy, investor relations, finance, and communications.

Loxam joined Kira Pharmaceuticals in November 2021 as Chief Operating Officer and Chief Financial Officer. In this role, she oversees finance, operations, and strategic functions for the company. Prior to joining Kira, Loxam served as Chief Financial Officer at SQZ Biotech. She was instrumental in helping the company raise over $200 million in private and public funding. This includes taking the company public through an IPO on the NYSE in October 2020.

Waddick has over 30 years of experience in financial and executive roles in the biotechnology and energy industries. He has substantial knowledge of public company management and corporate governance, and in designing, building, and managing financial processes, procedures, and infrastructure.

Waddick has served as Chief Financial Officer and Corporate Secretary of Cardiol since August 16, 2018. He serves as Executive Vice President and Chief Financial Officer for a private Ontario energy company.

Waddick has also spent more than twelve years at Vasogen Inc. While serving as Chief Financial Officer and Chief Operating Officer, the company grew from a start-up to an organization employing over 250 employees. Vasogen went public on the TSX and the NASDAQ, reaching a market capitalization of over US$1 billion.

In a news release, Chairman Torre commented on the appointments.

We are delighted that Teri and Chris have agreed to join our Board of Directors. Their extensive and diversified experience will be invaluable to our continued growth and success as we advance the development of important new anti-fibrotic and anti-inflammatory therapeutics for the treatment of heart disease.”

Also serving on the board of directors is Colin G. Stott, BSc (Hons), Chief Operating Officer of Alinova Biosciences Ltd. He has three decades worth of experience in pre-clinical and clinical development, with specific expertise in the development of cannabinoid-based medicines.

He was the former Scientific Affairs Director, International and R&D Operations Director for GW Pharmaceuticals plc, a world leader in the development of cannabinoid therapeutics. A world authority on cannabidiol, he was largely responsible for the success of Epidiolex® and strongly feels that, whereas Epidiolex® was focused on neuroinflammation, he believes that inflammation, at the heart is, is something that he could be treating.

Investment summary:

There is a lot happening at Cardiol Therapeutics to energize investor excitement. Looking at its intellectual property, the Company boasts a comprehensive portfolio that covers and protects the formulation of CardiolRx™ as well as its formulations that target indications of heart disease.

When you look at a company like Cardiol, its main formulation being used for its clinical trials, CardiolRx™, consists of a molecule, CBD, that has been safely used anecdotally for thousands of years. CBD has also been FDA approved to treat rare forms of child-onset epilepsy successfully and safely in thousands of children. Virtually every mammal on earth has an endocannabinoid system in the body that is very receptive to various cannabinoids, including CBD.

The company is developing CBD formulations to reduce inflammation and fibrosis of the heart to treat diseases that impact the lives of thousands of people and their loved ones.

For the latest on the Company, visit cardiolrx.com.

The post A medical play developing CBD-based treatments for cardiovascular diseases appeared first on The Market Herald.

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Spread & Containment

Decrease in Japanese children’s ability to balance during movement related to COVID-19 activity restrictions

A team of researchers from Nagoya University in central Japan investigated how restrictions on children’s activities during the COVID-19 pandemic affected…

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A team of researchers from Nagoya University in central Japan investigated how restrictions on children’s activities during the COVID-19 pandemic affected their life habits and their abilities to perform physical activities. By comparing medical examination data before and after the onset of the pandemic, they found that physical functions among adolescents deteriorated, including their dynamic balance. They also found that the children had higher body fat levels and worse life habits. Rather than a lack of exercise time, this may have been because of a lack of quality exercise due to activity restrictions.  

Credit: Credit must be given when image is used

A team of researchers from Nagoya University in central Japan investigated how restrictions on children’s activities during the COVID-19 pandemic affected their life habits and their abilities to perform physical activities. By comparing medical examination data before and after the onset of the pandemic, they found that physical functions among adolescents deteriorated, including their dynamic balance. They also found that the children had higher body fat levels and worse life habits. Rather than a lack of exercise time, this may have been because of a lack of quality exercise due to activity restrictions.  

During the COVID-19 pandemic, in Japan, as in other countries, schools and sports clubs tried to prevent the spread of infection by reducing physical education and restricting outdoor physical activities, club activities, and sports. However, children who are denied opportunities for physical activity with social elements may develop bad habits. During the pandemic, children, like adults, increased the time they spent looking at television, smartphone, and computer screens, exercised less, and slept less. Such changes in lifestyle can harm adolescent bodies, leading to weight gain and health problems. 

Visiting Researcher Tadashi Ito and Professor Hideshi Sugiura from the Department of Biological Functional Science at the Nagoya University Graduate School of Medicine, together with Dr. Yuji Ito from the Department of Pediatrics at Nagoya University Hospital, and  Dr. Nobuhiko Ochi and Dr. Koji Noritake from Aichi Prefectural Mikawa Aoitori Medical and Rehabilitation Center for Developmental Disabilities, conducted a study of Japanese children and students in elementary and junior high schools, aged 9-15, by analyzing data from physical examinations before and during the COVID-19 pandemic. They evaluated the children’s muscle strength, dynamic balance functions, walking speed, body fat percentage, screen time, sleep time, quality of life, and physical activity time.  

The researchers found that after the onset of the pandemic, children were more likely to have decreased balance ability when moving, larger body fat percentage, report spending more time looking at TV, computers or smartphones, and sleep less. Since there were no changes in the time spent on physical activity or the number of meals eaten, Sugiura and his colleagues suggest that the worsening of physical functions was related to the quality of exercise of the children. The researchers reported their findings in the International Journal of Environmental Research and Public Health.  

“Since the outbreak of the novel coronavirus in Japan after April 2020, children have not been able to engage in sufficient physical education, sports activities, and outdoor play at school. It became clear that balance ability during movement was easily affected, lifestyle habits were disrupted, and the percentage of body fat was likely to increase,” explained Ito. “This may have been because of shorter outdoor playtime and club activities, which impeded children’s ability to learn the motor skills necessary to balance during movement.” 

“Limitations on children’s opportunities for physical activity because of the outbreak of the novel coronavirus have had a significant impact on the development of physical function and lifestyle and may cause physical deterioration and health problems in the future,” warned Ito. “Especially, the risk of injury to children may increase because of a reduced dynamic balance function.” 

The results suggest that even after the novel coronavirus becomes endemic, it is important to consider the effects of social restrictions on the body composition of adolescents. Since physical activities with a social element may be important for health, authorities should prioritize preventing the reduction of children’s physical inactivity and actively encourage them to play outdoors and exercise. The group has some recommendations for families worried about the effects of school closings and other coronavirus measures on their children. “It is important for children to practice dynamic balance ability, maintaining balance to avoid falling over while performing movements,” Ito advised. “To improve balance function in children, it is important to incorporate enhanced content, such as short-term exercise programs specifically designed to improve balance functions.” 


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Government

Contradictions, Lies, And “I Don’t Recalls”: The Fauci Deposition

Contradictions, Lies, And "I Don’t Recalls": The Fauci Deposition

Authored by Techno Fog via The Reactionary,

Today, Missouri Attoney General…

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Contradictions, Lies, And "I Don't Recalls": The Fauci Deposition

Authored by Techno Fog via The Reactionary,

Today, Missouri Attoney General Eric Schmitt released the transcript of the testimony of Dr. Anthony Fauci. As you might recall, Fauci was deposed as part of an ongoing federal lawsuit challenging the Biden Administration’s violations of the First Amendment in targeting and suppressing the speech of Americans who challenged the government’s narrative on COVID-19.

Here is the Fauci deposition transcript.

And here are the highlights…

EcoHealth Alliance - the Peter Daszak group - is knee-deep in the Wuhan controversy, having been funded by the Fauci’s NIH for coronavirus and gain of function research in China (and having worked with the Chinese team in Wuhan). What does Fauci say about EcoHealth Alliance? Over two years after the COVID-19 pandemic began, and after millions dead worldwide, he’s “vaguely familiar” with their work.

In early 2020, Fauci was put on notice that his group - NIAID - had funded EcoHealth alliance on bat coronavirus research for the past five years.

This coincided with early reports - directly to Fauci, from Jeremy Ferrar and Christian Anderson - “of the possibility of there being a manipulation of the virus” based on the fact that “it was an unusual virus.”

Fauci conceded that he was specifically made aware by Anderson that “the unusual features of the virus” make it look “potentially engineered.”

Fauci couldn’t recall why he sent an article discussing gain of function research in China to his deputy, Hugh Auchincloss, telling him it was essential that they speak on the phone. He couldn’t recall speaking with Auchincloss via phone that day. But remarkably, Fauci did remember assigning research tasks to Auchincloss

Fauci was evasive on conversations with Francis Collins about whether NIAID may have funded coronavirus-related research in China, eventually stating “I don’t recall.”

The phrase “I don’t recall” was prominent in Fauci’s deposition. He said it a total of 174 times:

For example, Fauci couldn’t remember what anyone said on a call discussing whether the virus originated in a lab:

During that same call, Fauci couldn’t recall whether anyone expressed concern that the lab leak “might discredit scientific funding projects.” He also couldn’t recall whether there was a discussion about a lab leak distracting from the virus response. Fauci did remember, however, that they agreed there needed to be more time to investigate the virus origins - including the lab leak theory.

What else couldn’t Fauci remember? Whether, early into the pandemic, his confidants raised concerns about social media posts about the origins of COVID-19.

Yet Fauci did admit he was concerned about social media posts blaming China for the pandemic. He even admitted the accidental lab leak “certainly is a possibility,” contradicting his prior claims to National Geographic where he said the virus “could not have been artificially or deliberately manipulated.”

Fauci also couldn’t recall whether he had any conversations with Daszak about the origins of COVID-19 in February 2020, but admitted those conversations might have happened: “I told you before that I did not remember any direct conversations with him about the origin, and I said I very well might have had conversations but I don't specifically remember conversations.” And he couldn’t recall telling the media early on during the pandemic that the virus was consistent with a jump “from an animal to a human.”

Fauci said he was in the dark on social media actions to curb speech and suspend accounts that posted COVID-19 information that didn’t fit the mainstream narrative: “I’m not aware of suppression of speech on social media.” Yet it was Fauci’s proclamations of the truth, whether about the origins of COVID-19 to the effectiveness of hydroxychloroquine, that led to social media companies banning discussions of contrary information.

Regarding those removals of content, Fauci had no personal knowledge of a US Government/Social Media effort to curb “misinformation.” But he conceded the possibility numerous times.

Then there’s the issue of masks. In February 2020, Fauci informed an acquaintance that was traveling: “I do not recommend that you wear a mask.” Fauci would later become a vocal proponent of masks only two months later.

I’m near my Substack length limit - posting the excerpts does that - but you can see from Fauci’s testimony that his public statements about COVID-19 origins and the necessity to wear a mask didn’t match his private conversations. This has been known for some time, but it’s finally nice to get him on record.

Again, read it all and subscribe here.

Tyler Durden Mon, 12/05/2022 - 21:40

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International

Global Wages Take A Hit As Inflation Eats Into Paychecks

Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook…

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Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook clouded by uncertainties have led to a decline in real wages around the world, a new report published by the International Labour Organization (ILO) has found.

As Statista's Felix Richter reports, according to the 2022-23 Global Wage Report, global real monthly wages fell 0.9 percent this year on average, marking the first decline in real earnings at a global scale in the 21st century.

You will find more infographics at Statista

The multiple global crises we are facing have led to a decline in real wages.

"It has placed tens of millions of workers in a dire situation as they face increasing uncertainties,” ILO Director-General Gilbert F. Houngbo said in a statement, adding that “income inequality and poverty will rise if the purchasing power of the lowest paid is not maintained.”

While inflation rose faster in high-income countries, leading to above-average real wage declines in North America (minus 3.2 percent) and the European Union (minus 2.4 percent), the ILO finds that low-income earners are disproportionately affected by rising inflation. As lower-wage earners spend a larger share of their disposable income on essential goods and services, which generally see greater price increases than non-essential items, those who can least afford it suffer the biggest cost-of-living impact of rising prices.

“We must place particular attention to workers at the middle and lower end of the pay scale,” Rosalia Vazquez-Alvarez, one of the report’s authors said.

“Fighting against the deterioration of real wages can help maintain economic growth, which in turn can help to recover the employment levels observed before the pandemic. This can be an effective way to lessen the probability or depth of recessions in all countries and regions,” she said.

Tyler Durden Mon, 12/05/2022 - 20:00

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