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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…



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

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

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NYC biotech LB Pharmaceuticals eyes $75M for new take on decades-old schizophrenia drug

As Karuna Therapeutics wraps up its FDA approval request for what could be the first new type of schizophrenia drug in decades, another East Coast biotech…



As Karuna Therapeutics wraps up its FDA approval request for what could be the first new type of schizophrenia drug in decades, another East Coast biotech is raising $75 million to test an adjusted version of a decades-old medicine for the disorder next year.

LB Pharmaceuticals has secured about $35 million so far and expects another $40 million in the round, according to an SEC filing on Thursday. Per the financial document, its board includes directors associated with Vida Ventures, Pontifax, Deep Track Capital and TCGX, a crossover firm that has invested in multiple nine-figure biotech financings in recent months, including Carmot Therapeutics, Alkeus and Upstream Bio.

LB declined to comment.

The New York City biotech plans to run a Phase II trial of a chemically differentiated form of amisulpride, a D2 and D3 antagonist that has been available in Europe and more than 50 countries for decades, according to an investor deck from June. Sanofi marketed it as Solian, which generated €135 million in sales in 2002 for the French Big Pharma. It’s since become available as a generic.

LB’s board includes Piero Poli, CEO of Swiss drugmaker Rivopharm, which produces generic amisulpride. In February 2020, Acacia Pharma secured FDA approval for an IV formulation of amisulpride in certain postoperative patients with nausea, marketing it as Barhemsys.

With its methylated version of amisulpride, LB says its oral asset LB-102 has the potential to be more effective at lower doses by improving blood-brain barrier permeability, per the investor deck. Its new chemical structure gives LB-102 IP protection until “at least 2037.” LB has positioned the drug as a blockbuster treatment that could generate $1 billion or more in annual sales, pointing to antipsychotic prescriptions in the EU with an average price of $2,000 per month.

The drug is set to go into Phase II testing in adults with acute schizophrenia in the first quarter of next year, per the June document.

The company expects to enroll about 350 people at 25 sites, testing whether three doses of the drug are better than placebo based on the commonly used schizophrenia clinical trial measure known as PANSS, or Positive and Negative Syndrome Scale. Karuna’s M1/M4-preferring muscarinic agonist KarXT has passed two Phase III trials that use that measure, leading to massive financing hauls for the biotech and Cerevel Therapeutics. Boston-based Karuna plans to submit its approval request to the FDA this quarter. Meanwhile, Sumitomo and Otsuka’s ulotaront failed a Phase III on the PANSS test two months ago.

LB expects the study to focus on in-patients for four weeks. Pending the mid-stage results, the company would likely then take LB-102 into multiple Phase III trials in 2025, with plans to submit an NDA in 2028, per the June presentation. The company sees schizophrenia as the first step, with potential for studies in depression, bipolar depression and other indications.

Zachary Prensky

The drug developer is led by a former family office manager, CEO Zachary Prensky. LB’s medical chief is Anna Eramo, who previously ran clinical and medical affairs at Lundbeck’s US operations and worked on the development of Rexulti, approved for schizophrenia and other indications. Science chief Andrew Vaino and chief financial officer Marc Panoff were previous executives at Retrophin.

Prensky co-founded LB with Vincent Grattan, a pharmacist who came across amisulpride in the 2000s while working on medication managements in multiple prisons. “As many are aware, correctional facilities are de facto mental health hospitals, and I wanted to make sure we were stocking the most reliable medications,” he told Psychiatric News in 2021.

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Dana-Farber, Brigham breakup could lead to a ripple effect for CGT clinical trials for cancer

Dana-Farber Cancer Institute announced on Sept. 14 that it is securing a new joint venture with Beth Israel Deaconess Medical Center, marking a breakup…



Dana-Farber Cancer Institute announced on Sept. 14 that it is securing a new joint venture with Beth Israel Deaconess Medical Center, marking a breakup of its decadeslong adult cancer care partnership with Brigham and Women’s Hospital.

The news shocked Brigham, which had been negotiating a partnership extension with Dana-Farber for the past 15 months, according to the Boston Globe.

There are around 20 ongoing cell therapy clinical trials under the Dana-Farber Brigham Cancer Center, which comprises 12 treatment centers with experts from Dana-Farber and Brigham working together. Brigham also has its own gene and cell therapy institute and a lab dedicated to next-generation, genetically-modified CAR-T cell therapies for cancer.

With the Dana-Farber contract set to end in 2028, concerns have been raised about the impact on current cell and gene therapy (CGT) studies and ones that are scheduled to start, due to the complex nature of the treatments involved.

Jason Foster

Manufacturing CGTs is a skill- and labor-intensive process. Ori Biotech CEO Jason Foster told Endpoints News that hospitals and research centers often work together to make them on-site for clinical trials, with highly skilled experts from the specialty centers playing a key role. UK-based Ori develops technologies that automates CGT manufacturing.

At Dana-Farber Brigham Cancer Center’s cellular therapies program, cells are processed at an outside commercial facility or at the Connell and O’Reilly Families Cell Manipulation Core Facility.

When such partnerships come to an end, “that kind of [specialist] knowledge loss is something that will impact both the trajectory of [CGT] trials, but also the time it takes to get these products to patients,” Foster added.

These potential negative impacts on trials would only compound preexisting barriers to access to CGTs, including high costs and lengthy manufacturing processes. Estimates suggest that 25% of patients die while waiting for CAR-T treatments, according to ASCO Post.

Lee Buckler

Lee Buckler, senior vice president of advanced therapies at Blood Centers of America, told Endpoints in an email that collaboration between research institutes and healthcare providers was of significant — if not critical — value to the testing of CGTs.

A Brigham spokesperson said that the hospital is one of the largest recipients of NIH funding and does not expect any changes to trials already under agreement, adding it would continue to be a leader in the CGT space. “We are also planning for a new, state of the art Brigham facility which will include the medical oncology specialty,” the spokesperson said.

Dana-Farber did not respond to Endpoints before deadline.

Problems with CGT trials could be both the cause and the effect of partnership breakdowns. Buckler said that general hospitals are often reluctant to facilitate the kinds of clinical trial protocols associated with innovative CGTs, which may drive research centers to align with partners more willing to prioritize them.

Under the new partnership with Beth Israel, Dana-Farber plans to create a free-standing state-of-the-art cancer hospital, which it said would have the flexibility to “incorporate the innovations and technology in cancer care that Dana-Farber’s and BIDMC’s researchers and clinicians are developing every day.”

Vered Caplan

But a dedicated cancer hospital is not necessarily better at carrying out CGT trials than a general hospital with a tightly-integrated cancer specialty.

“I’ve seen general hospitals with tremendous capabilities and specific hospitals with tremendous capabilities — it really depends on the particular hospital,” Orgenesis CEO Vered Caplan told Endpoints in an interview. Germantown, MD-headquartered Orgenesis rolls out CGT mobile processing units and labs for cancer treatment to hospitals.

Regardless, the breakup means Dana-Farber must convince patients that its program with Beth Israel will provide at least the same quality care as the Brigham partnership, while Brigham must rebuild its specialist capabilities without Dana-Farber expertise.

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Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

By all accounts, Zelensky came away from his Washington visit with…



Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

By all accounts, Zelensky came away from his Washington visit with nothing new. Biden did announce a fresh $325 million aid package for Ukraine from already committed funds, but the hoped-for long range missile approval never came (however, more cluster bombs are being sent). And as we detailed Thursday, House Republican leadership once again failed to move forward on a mere procedural vote for the Pentagon funding bill, due in large part to GOP members rejecting Biden's proposed $24 billion more in Ukraine aid.

Thursday's package announced by Biden, as Zelensky visited the White House and Capitol Hill, was run-of-the-mill and entirely to be expected. "Today I approved the next tranche of U.S. security assistance to Ukraine including more artillery, more ammunition, more anti-tank weapons and next week, the first U.S. Abrams tanks will be delivered to Ukraine," Biden said.

As for the earlier in the day (Thurs.) meeting with Congressional leaders, House Speaker Kevin McCarthy explained when asked why the Ukrainian leader's request to address Congress was denied, "Zelensky asked for a joint session, we just didn't have time. He's already given a joint session."


Instead in a closed-door meeting, Zelensky later acknowledged he discussed with lawmakers "the battlefield situation and priority defense needs."

But if there is any level of consolation for Kiev, it's seen in the Pentagon announcement which came late in the day Thursday. Facing potential US government shutdown on Oct.1st, given at this point Congress is not expected to pass the 12 appropriations bills needed to fund government operations before next fiscal year, the Pentagon has said it will exempt its operations supporting Ukraine from a shutdown. 

The military typically suspends any activities not deemed vital to national security during government shutdowns, thus the DoD is in effect saying Ukraine aid remains "vital to national security". 

"Operation Atlantic Resolve is an excepted activity under a government lapse in appropriations," Pentagon spokesman Chris Sherwood told Politico, in reference to the operational name still used for actions supporting Kiev.

But Politico points out a potential shutdown would still negatively impact US support to Ukraine:

Sherwood noted that while DOD’s activities related to Ukraine will continue, furloughs and other activities halted under the shutdown could still have a negative impact.

"Training would happen, but depending on whether or not there were certain personnel that were not able to report for duty, for example, that could have an impact," said Pentagon spokesperson Brig. Gen. Patrick Ryder on Thursday.

This Pentagon exemption to keep Ukraine-related support active during a government shutdown seems to be the only significant thing Zelensky came away with. 

It appears to have been the main object of discussion when Zelensky met with Secretary of Defense Lloyd Austin in Washington during the trip. The Pentagon said this was "to reaffirm the steadfast US support for Ukraine."

Meanwhile, Bloomberg takes note of Zelensky "showing the strain" amid increasing divisions among allies:

The Ukrainian president allowed a dispute with one of his biggest allies to spin out of control at the United Nations General Assembly this week, and that’s just a hint of the tensions building behind the scenes.

Zelenskiy has been leading his country through Russia’s brutal assault for 19 months, all the time fighting on another front to wring the weapons and finance he needs from his US and European supporters. Now he suspects that President Joe Biden’s commitment is wavering and other leaders may be taking their cue from the US, according to a person who met with him recently.

He grew very emotional at times during that discussion, the person said, and was scathing in his criticism of nations that he said weren’t delivering weapons quickly enough.

Washington's lackluster greeting of Zelensky this week (compared to how he was received in December 2022) came simultaneous to Poland declaring it will no longer arm Ukraine, amid a fierce diplomatic spat over blockage of Ukraine grain imports by Warsaw, to protect Polish farmers.

The Economist is also taking note of the significant mood shift among Western allies...

A "long war" indeed... given a G7 leader from a European country has told reporters this week that the West is prepared for a years-long war, something likely to last some six or seven years, according to the quote.

"A senior official from one European G-7 country said the war may last as much as six or seven more years and that allies need to plan financially to continue support for Kyiv for such a long conflict," Bloomberg wrote.

Tyler Durden Fri, 09/22/2023 - 10:15

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