Original-Research: Cardiol Therapeutics - von GBC AG
Einstufung von GBC AG zu Cardiol Therapeutics
Unternehmen: Cardiol Therapeutics
Anlass der Studie: Research Comment
Kursziel: 17,49 CAD
Kursziel auf Sicht von: 31.12.2022
Analyst: Julien Desrosiers; Felix Haugg
On August 24th, Cardiol Therapeutics received FDA Clearance of Investigational New Drug (IND) Application for Phase II Clinical Trial of CardiolRx(TM) for Acute Myocarditis.
Phase II trial details
The company's Investigational New Drug (IND) application approval allows Cardiol Therapeutics to commence a Phase II, multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx(TM), as well as its impact on myocardial recovery in patients presenting Acute Myocarditis.
More specifically, Cardiol's Acute Myocarditis study is expected to enroll 100 patients at clinical centers in the United States and Europe. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with Acute Myocarditis.
The study has been designed by an independent steering committee comprising distinguished thought leaders in Heart Failure and Myocarditis from international centers of excellence, including: the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, Charité Hospital Berlin, and the University of South Florida Health Morsani College of Medicine/Tampa General Hospital Heart and Vascular Institute.
Comments from the Company
'IND clearance to proceed with our Phase II clinical trial of CardiolRx in patients with Acute Myocarditis represents another major milestone for Cardiol as we continue to pursue the development of new treatment options for patients with inflammatory Heart Disease,' said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. 'We look forward to further studying the cardioprotective potential of CardiolRx in this rare but potentially devastating condition that remains an underdiagnosed cause of Acute Heart Failure, sudden death, and chronic dilated Cardiomyopathy.'
GBC Research report update
As per our Initial Coverage report, we planned for an approval of the Phase II clinical trial of CardiolRx in patients with Acute Myocarditis to be received in Q3 2021. We are pleased to see the company being on track at this point.
We view the approval of the IND Phase II clinical trials as a critical development for the company.
This new step marks the beginning of a new phase for Cardiol Therapeutics as treatment for Acute Myocarditis is, according to our forecast, the main value driver for the company in the near future. We estimate patient enrollment could begin as early as within the next few months. We maintain our forecast of the phase II results to be announced in Q1 2023 and our target price and rating remain unchanged.
As of August 2021, the company has appointed Dr. Guillermo Torre-Amione as its new chairman. M. Guillermo has served as an independent director since August 2018.
Dr. Guillermo Torre-Amione
Dr. Torre-Amione received his medical degree from Tecnológico de Monterrey, Campus Monterrey in 1985 and earned a PhD in Immunology from the University of Chicago in 1990. He subsequently completed his training in Internal Medicine and Cardiology with subspecialty training in Cardiac Transplantation and Interventional Cardiology at Baylor College of Medicine in Houston Texas.
Dr. Torre-Amione was presiding the Heart Failure and Cardiac Transplantation Section at the Methodist Hospital in Houston from 1995 to 2010. He then became a full Professor of Medicine at Weill Cornell Medical College at The Methodist Hospital in Houston in 2008. During his tenure at The Methodist Hospital he was a board member of the Heart and Vascular Center, and established the Cardiac Transplantation research endowment. Furthermore, he was a board member of St Thomas University in Houston Texas.
After 26 years in the United States, he returned to Mexico to become President of TEC Salud at the Tecnológico de Monterrey. He is currently an active member of the staff of both the San Jose Tec de Monterrey Hospital and Zambrano Hellion Medical Center. He also maintains an academic appointment at the Methodist Hospital in Houston.
M. Torre-Amione has carried out more than 100 clinical research projects, holds several patents in the field of Heart Failure and has published over 170 peer reviewed professional articles.
We believe that Dr. Torre-Amione is an important step forward in the company's leadership composition. Cardiol Therapeutics will be greatly enhanced by his vast experience in both scientific and clinical research on Heart Failure, including the design and execution of pivotal clinical trials in this area.
As of September 7th, 2021, the company has appointed Michael J. Willner to its Board of Directors.
Michael J. Willner earned a bachelor's degree in Accounting and Finance from the University of South Florida and a law degree from Emory University, where he was a member of the Emory Law Review. Prior to entering the legal profession, Mr. Willner worked for the former Arthur Andersen & Company, a national accounting firm, where he practiced in the tax department. Following that, he worked for Milbank, Tweed, Hadley & McCloy, one of the nation's most prominent international law firms, in New York City.
In 1990, Mr. Willner founded Willner Capital, Inc., an investment firm specialized in public and private equities, as well as debt instruments. Since over 30 years, Willner Capital focuses on fundamental analysis and event-driven tactics. Willner Capital has made major investments in the biotechnology and pharmaceutical cannabinoid industries over the last decade, focusing on clinical-stage firms seeking to solve unmet medical needs.
The New York Times Business Section has quoted Mr. Willner on his investments in the pharmaceutical side of the marijuana industry, and he has participated in various panel discussions and advisory boards.
These three news reports combined together strengthen unquestionably our confidence in Cardiol Therapeutics' overall chances of success.
Target price: 17,49 CAD (confirmed)
Die vollständige Analyse können Sie hier downloaden: http://www.more-ir.de/d/22889.pdf
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Date and time of completion of this research: 08/09/2021 (06:20 pm) Date and time of first distribution: 09/09/2021 (02:00 am)
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